Scalp Block Versus Scalp Infiltration With Dexmedetomidine and Local Anesthetic for Post Craniotomy Pain

Efficacy of Dexmedetomidine as an Adjuvant to Local Anesthetic Agent in Scalp Block and Scalp Infiltration to Control Post Craniotomy Pain

This study has been designed to assess the efficacy of dexmedetomidine as an adjuvant to local anaesthetic agent bupivacaine in scalp nerve block and scalp infiltration to control post craniotomy pain.A third group where patients were administered bupivacaine only infiltration has also been created.

Study Overview

• Status: Completed
• Conditions: Headache
• Intervention / Treatment: Procedure: scalp block; Drug: Dexmedetomidine; Drug: Bupivacaine; Procedure: infiltration

Detailed Description

Patients were randomly allocated into three equal groups by computer generated random numbers. For randomization, the simple random allocation rule was followed, wherein the total sample size (n = 150) was randomly divided into three equal groups. In the event of any case has to be excluded because of requirement of postoperative ventilation, altered sensorium or high grade fever in the post-operative period, the same random number code was allocated to the next patient in order to ensure an equal sample size without any modification to the original random number table. The random numbers were then kept in opaque sealed envelopes, numbered sequentially which were opened just before shifting patient inside operation theatre.

The anaesthesiologist who prepared and administered the study drug were not involved in collection of data. The anaesthesiologist who collected the data from the patient in the postoperative period, the operating surgeon and the patient were blinded to the group assigned to the patient.

Pre-operative Assessment:

Pre-operative anaesthetic evaluation was done on the day prior to the surgery. This included a detailed history regarding physical health, any co-morbid illness, current medications, drug allergy and previous anaesthetic experience. The patient was made familiar about the NRS (0-10, with 0 = no pain, 10 = worst pain ever). A written and informed consent was taken. Patients were fasted and premedicated according to the departmental protocol.

Duration of study period-

Study period started after closure of skin incision of the scalp and continued till 48 hours in the postoperative period

Study groups-

Patients were randomly divided into three groups:

Group BI - Bupivacaine infiltration around surgical incision.

Group BDI - Bupivacaine and dexmedetomidine infiltration around surgical incision

Group BDNB- Bupivacaine and dexmedetomidine used in scalp nerve block.

Anaesthesia Technique-

A standard anaesthesia technique according to the departmental protocol was followed in all the patients. Pre-induction monitoring (Datex- Ohmeda S/5 Avance, Madison, WI, USA) consisted of 5-lead electrocardiography, heart rate, automated non-invasive blood pressure, and pulse oximetry. The patients were then be induced with propofol (1-2 mg/kg) or thiopentone (4-6mg/kg) and trachea were intubated with vecuronium 0.1 mg/kg. Anaesthesia was maintained with intravenous (propofol) or inhalational (isoflurane/sevoflurane/desflurane) anaesthetic agent along with nitrous oxide-oxygen mixture (60:40) and intermittent doses of intravenous vecuronium (0.02 mg/kg). Ventilation was maintained at ETCO2 30 to 35mm Hg. Total fresh gas flow rate was kept at 1-2 L/min. A radial artery catheter was inserted for continuous blood pressure monitoring and blood sampling if indicated. Intraoperative analgesia was maintained with intravenous morphine 0.1mg/kg and morphine repeated at a dose of 0.05 mg/kg if duration of surgery was more than 3 hours. Patients were reversed with neostigmine (0.05mg/kg) and glycopyrolate (0.01mg/kg) after administration of study drugs and were extubated once patient started responding to verbal commands and able to generate adequate tidal volume under spontaneous respiration.

Methods of postoperative analgesia- In all the patients, analgesic procedure was done ensuring proper aseptic precaution at the end of the surgery, after closure of skin incision and before putting the dressings over the incision. Patients were reversed from anaesthesia after the administration of study drugs.

Group BI: The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

Group BDI: The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.

Group BDNB: Scalp nerve blocks were given with15-20 ml of combination of Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept less than 2 mg /kg.

In this group following nerves were blocked-

1. Supra-orbital nerve
2. Supra-trochlear nerve
3. Zygomatico-temporal nerve
4. Auriculo-temporal nerve
5. Posterior auricular branches of the greater auricular Nerve
6. The greater, lesser, and third occipital nerves

Post-operative assessment:

After extubation patients were shifted to the Post anaesthesia care unit (PACU) and assessed for haemodynamic parameters, sedation and any complication at 15 minutes interval till 2hrs and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours. Assessed for cognitive function at 30 min and 60 min.

Patients were followed after discharge for 6 months by telephonic communication at 1, and 3 month interval for presence of chronic pain.

COLLECTION OF DATA-

Preoperative- Age, sex, weight, ASA status, diagnosis, surgery

Intraoperative-

1. Site of incision
2. Duration of surgery
3. Intra-operative analgesia- morphine in mg/kg

Postoperative-

1. Haemodynamic parameters- Heart rate, systolic and diastolic blood pressure, oxygen saturation was recorded at arrival to PACU and every 15 min interval for 2 hours. Then heart rate and systolic and diastolic blood pressure at 4, 8, 12, 16, 20, 24, 36 and 48 hours after surgery.
2. Respiration rate-was recorded at arrival to PACU and every 15 min interval for 2 hours and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours after surgery.

3. Cognitive function- Patients were evaluated for cognitive function 30 minutes after shifting to PACU using a modified self-devised questionnaire of short orientation memory concentration test.

   Whenever the subjects were able to recall and count with minimal mistakes (1 to 3), were regarded as good, with more than 3 mistakes as fair, and if not be able to recall at all, it was regarded as poor. If the cognitive function outcome was poor then same test was repeated at 1 hour after shifting to PACU. If outcome was again poor, then that patient was excluded from the study.

4. Assessment of pain- Postoperative pain was assessed by Numerical rating scale (NRS) where in 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain'. It was assessed at arrival to PACU and at 0, 0.5, 1, 1.5, 2, 4, 8, 12, 16, 20, 24, 36 and 48 hours after surgery.
5. Pain free period- Time of first rescue analgesic administration from the time of test drug administration was recorded.
6. Postoperatively rescue analgesic- When NRS score was ≥ 4, rescue analgesic paracetamol 1gm was administered intravenously and total rescue analgesic requirement in 24 and 48 hrs were noted.
7. Rescue drugs to maintain haemodynamic stability- Any adverse events like bradycardia (Heart rate ≤ 40), hypotension (SBP < 90 mm of Hg) were recorded and treated by rescue drugs: atropine-15µg/Kg and mephenteramine-3mg/dose respectively. Total amount of rescue drug requirement in 24 and 48 hours were noted.
8. Postoperative sedation- Level of sedation was assessed using Modified Ramsay Sedation Scale.

9. Adverse events-

   1. Respiratory depressions (Respiration rate < 8 breaths/min) was recorded and managed accordingly.
   2. Postoperative nausea and vomiting (PONV) was assessed on a 4-point scale. and was treated with ondansetron 0.15 mg/kg intravenously if score was >2.

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Neurosurgical patients
• 18-70 years of age
• ASA class I and II
• Patients undergoing elective craniotomy, who were conscious and oriented to time, person and place and able to understand and use Numerical Rating Scale (NRS)

Exclusion Criteria:

• Patient dull and irritable
• GCS <15
• Craniotomy incision extending beyond scalp (the field of the block) e.g. craniofacial surgery
• Patients treated chronically with analgesics or narcotic medications
• Allergy to local anaesthetics or dexmedetomedine
• Patients planned for post-operative mechanical ventilation

Following patients were excluded from the study during collection of data in the postoperative period:-

• Patients developing fever (≥39°C) in the postoperative period
• Requiring postoperative ventilation (unplanned)
• Having poor cognitive function at 1 hour postoperative period
• GCS <15 in post-operative period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupivacaine,dexmedetomidine scalp block; Bupivacaine (0.25%) and Dexmedetomedine (1 µg/kg). Maximum dose of bupivacaine kept < 2 mg /kg for scalp block	Procedure: scalp block; In this group following nerves were blocked-; Supra-orbital nerve; Supra-trochlear nerve; Zygomatico-temporal nerve; Auriculo-temporal nerve; Posterior auricular branches of the greater auricular Nerve; The greater, lesser, and third occipital nerves; Drug: Dexmedetomidine; Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.; Other Names: Precedex; Dexdor; Drug: Bupivacaine; 20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration; Other Names: Marcaine; Sensorcaine; Marcain
Active Comparator: bupivacaine dexmedetomidine infiltration; The incision site was infiltrated with 15-20 ml bupivacaine (0.25%) and dexmedetomedine (1 µg/kg). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.	Drug: Dexmedetomidine; Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.; Other Names: Precedex; Dexdor; Drug: Bupivacaine; 20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration; Other Names: Marcaine; Sensorcaine; Marcain; Procedure: infiltration; The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.
Active Comparator: bupivacaine infiltration; The incision site was infiltrated with 15-20 ml of bupivacaine (0.25%). {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}. Maximum dose of bupivacaine kept less than 2 mg /kg.	Drug: Bupivacaine; 20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration; Other Names: Marcaine; Sensorcaine; Marcain; Procedure: infiltration; The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post craniotomy pain by Numerical rating scale (NRS)	Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain	Immediately after extubation
post craniotomy pain by Numerical rating scale (NRS)		30 minutes after extubation
post craniotomy pain by Numerical rating scale (NRS)		1 hour after extubation
post craniotomy pain by Numerical rating scale (NRS)		1.5 hours after extubation
post craniotomy pain by Numerical rating scale (NRS)		2 hours after extubation
post craniotomy pain by Numerical rating scale (NRS)		4 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		8 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		12 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		16 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		20 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		24 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		36 hours post extubation
post craniotomy pain by Numerical rating scale (NRS)		48 hours post extubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
chronic pain using Numerical rating scale (NRS)	Numerical rating scale (NRS) is a scale from 0 to 10 where 0 shows 'no pain' and 10 shows 'worst imaginable excruciating pain	1 month
chronic pain using Numerical rating scale (NRS)		3 months
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	15 minutes interval till 2hrs post extubation and then at 4, 8, 12, 16, 20, 24, 36 and 48 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	4 hours
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	8 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	12 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	16 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	20 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	24 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	36 hours.
post operative sedation using Modified Ramsay Sedation Scale	Sedation Score-- by Modified Ramsay Sedation Scale; Anxious/ Agitated/ Restless; Cooperative/ Oriented/ Tranquil; Responds to verbal commands; Brisk response to light glabellar tap or loud noise; Sluggish response to light glabellar tap or loud noise; No Response	48 hours.
rescue analgesic requirement in grams	total rescue analgesic requirement in grams of paracetamol consumed in 24 hours	24 hrs
rescue analgesic requirement in grams	total rescue analgesic requirement in grams of paracetamol consumed in 48 hours	48 hrs

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
heart rate in beats per minute(bpm)	15 minutes interval till 2hrs post extubation	15 minutes interval till 2hrs
heart rate in beats per minute(bpm)		4 hours.
heart rate in beats per minute(bpm)		8 hours.
heart rate in beats per minute(bpm)		12 hours.
heart rate in beats per minute(bpm)		16 hours.
heart rate in beats per minute(bpm)		20 hours.
heart rate in beats per minute(bpm)		24 hours.
heart rate in beats per minute(bpm)		36 hours.
heart rate in beats per minute(bpm)		48 hours.
systolic blood pressure in mm of Hg	15 minutes interval till 2hrs post extubation	15 minutes interval till 2hrs
systolic blood pressure in mm of Hg		4 hours.
systolic blood pressure in mm of Hg		8 hours.
systolic blood pressure in mm of Hg		12 hours.
systolic blood pressure in mm of Hg		16 hours.
systolic blood pressure in mm of Hg		20 hours.
systolic blood pressure in mm of Hg		24 hours.
systolic blood pressure in mm of Hg		36 hours.
systolic blood pressure in mm of Hg		48 hours.
Diastolic blood pressure in mm of Hg	15 minutes interval till 2hrs post extubation	15 minutes interval till 2hrs
Diastolic blood pressure in mm of Hg		4 hours.
Diastolic blood pressure in mm of Hg		8 hours.
Diastolic blood pressure in mm of Hg		12 hours.
Diastolic blood pressure in mm of Hg		16 hours.
Diastolic blood pressure in mm of Hg		20 hours.
Diastolic blood pressure in mm of Hg		24 hours.
Diastolic blood pressure in mm of Hg		36 hours.
Diastolic blood pressure in mm of Hg		48 hours.
SpO2 in percentage		15 minutes interval till 2hours.
SpO2 in percentage		4 hours.
SpO2 in percentage		8 hours.
SpO2 in percentage		12 hours.
SpO2 in percentage		16 hours.
SpO2 in percentage		20 hours.
SpO2 in percentage		24 hours.
SpO2 in percentage		36 hours.
SpO2 in percentage		48 hours.
respiratory rate in breaths per minute	respiratory rate in breaths per minute at 15 minutes interval till 2hrs in post operative period after extubation	15 minutes interval till 2hrs
respiratory rate in breaths per minute		4 hours.
Respiratory rate in breaths per minute		8 hours.
Respiratory rate in breaths per minute		12 hours.
Respiratory rate in breaths per minute		16 hours.
Respiratory rate in breaths per minute		20 hours.
Respiratory rate in breaths per minute		24 hours.
Respiratory rate in breaths per minute		36 hours.
Respiratory rate in breaths per minute		48 hours.
cognitive function using Modified self-devised questionnaire of short orientation memory concentration	Modified self-devised questionnaire of short orientation memory concentration test; What date is it today?; What is the current year?; What is his/her birthday?; Count numbers 1 to 10.; Count reverse numbers from 10 to 1.	30 minutes
cognitive function using Modified self-devised questionnaire of short orientation memory concentration	Modified self-devised questionnaire of short orientation memory concentration test; What date is it today?; What is the current year?; What is his/her birthday?; Count numbers 1 to 10.; Count reverse numbers from 10 to 1.	60 minutes
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	15 minutes interval till 2hrs
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	4 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	8 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	12 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	16 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	20 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	24 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	36 hours.
post operative nausea vomiting using Postoperative Nausea and Vomiting Scale	Postoperative Nausea and Vomiting Scale; No PONV: Absence of any emesis or nausea.; Mild PONV: Patient having only mild nausea / one emetic episode / nausea lasting for less than 10 minutes and where no antiemetic is required.; Moderate PONV: Patient has 1-2 emetic episodes / moderate to severe nausea and antiemetic therapy is required.; Severe PONV: Patient has more than 2 emetic episodes / is nauseated more than twice & more than one antiemetic required.	48 hours.

Collaborators and Investigators

• Sponsor: NAVNEH SAMAGH
• Collaborators: Postgraduate Institute of Medical Education and Research, Chandigarh

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 3, 2016
• First Submitted That Met QC Criteria: August 10, 2016
• First Posted (Estimate): August 15, 2016

Study Record Updates

• Last Update Posted (Estimate): August 15, 2016
• Last Update Submitted That Met QC Criteria: August 10, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: dexmedetomidine; nerve block; anesthesia infiltration
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: NK/1062/MD/13422-423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided