Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in TAP Blocks

Comparative Study of Ropivacaine and Ropivacaine With Dexmeditomedine in Transversus Abdominis Plane (TAP) Block for Post-operative Analgesia in Patients Undergoing Cesarean Sections

Comparative study of Ropivacaine and Ropivacaine with dexmedetomidine in transversus abdominis plane (TAP) block for post-operative analgesia in patients undergoing Caesarean Section.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Other: Ropivacaine; Drug: Ropivacaine + Dexmedetomidine

Detailed Description

Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. Routine NPO protocols will be followed. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique in Triangle of Petit with 2 inches 24 G needle.

Patients would receive 75 mg of intramuscular diclofenac sodium immediately on shifting to the postoperative care unit (PACU) and a second dose 12 hours later. The time after the TAP block when rescue analgesia was first sought, total dose of required morphine in 24 hours postoperatively, its adverse effects like pruritus, nausea and vomiting will be recorded. VAS will be used to assess post-operative pain (VAS; where 0 = no pain and 10 = worst imaginable pain) during rest and on coughing.

Rescue analgesia would be provided with 6 mg of intravenous morphine and additional doses of 3 mg at 10 minutes interval till VAS was less than 3 or in case of development of adverse effects such as nausea and/or vomiting, respiratory depression (SpO2 <92%, ventilatory frequency rate <10), or occurrence of deep sedation (eyes closed >3 min, Ramsay Score RS >2). An RS on a 6-point scale was used (1=anxious and agitated patient; 2=cooperative patient; 3=asleep patient, brisk response to loud voice; 4=asleep patient, sluggish response to loud voice; 5=no response to loud voice; score of 6=no response to pain). In PACU and in first 24 h post-operatively, MAP, HR, VAS (at rest and on coughing), nausea and vomiting, sedation score (RS) will be recorded on admission to PACU and at 1,4, 8, 12, 18 and 24 hours post-operatively by an observer who will be unaware of the study protocol.

Patients will we assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. Nausea and vomiting will be recorded using a categorical scoring system (0 = none, 1 = nausea, 2 = retching, 3 = vomiting). IV Metoclopramide 10 mg bolus will be offered for any patient with a score >/=1.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Jharkhand
    • Jamshedpur, Jharkhand, India, 831001
      • Tata Main Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• ASA 1 or 2
• Age above 18 years
• Patients for Lower Section Cesarean Section surgery

Exclusion Criteria:

• Patient refusal
• Allergy to study medications
• Localized infection over injection point
• Patients with significant coagulopathies and with contraindications to regional anesthesia
• Patients with a history of cardiac, respiratory, renal or hepatic failure
• Psychological disorders
• Chronic use of pain medications or adrenoreceptors agonists or antagonists.
• BMI >35 or weight < 50 kilograms

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Ropivacaine; Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)	Other: Ropivacaine; Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
Experimental: Ropivacaine + Dexmedetomidine; Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block	Drug: Ropivacaine + Dexmedetomidine; Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine and 1 micrograms/kg dexmedetomidine (combination drug) diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block; Other Names: selective alpha 2 (α2) adrenergic agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Time After the TAP Block When Rescue Analgesia Was First Sought	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Total Dose of Required Morphine in 24 Hours Postoperatively	24 hours
Adverse Effects Like Pruritus, Nausea and Vomiting	24 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Arterial Pressure (MAP): Intraoperative Period	The Mean Arterial Pressure (MAP) of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.	Upto 60 minutes
Heart Rate: Intraoperative Period	The Heart Rate of the patients were recorded from the start of surgery up to 60 minutes at 5, 10, 20, 30, 40, 50, 60 mins. No surgery lasted more than 60 minutes.	60 minutes
Time to Complete Disappearance of Motor Block	During the postoperative recovery, the level of motor block was assessed with Modified Bromage Scale 0 = no paralysis, able to flex hips/knees/ankles; = able to move knees, unable to raise extended legs; = able to flex ankles, unable to flex knees; = unable to move any part of the lower limb The time from subarachnoid block to complete disappearance of motor block (Bromage 0) was recorded in minutes.	24 hours
Duration of Sensory Loss at T10 Level	The duration of sensory loss (from the subarachnoid block) at T10 level was assessed by pin-prick test by a sterile needle in minutes.	24 hours
Mean Arterial Pressure (MAP): Postoperative Period	The Mean Arterial Pressure (MAP) of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.	24 hours
Heart Rate: Postoperative	The Heart Rate of the patients were recorded after shifting from Operation Theater and at 1, 4, 8,12,18 and 24th hour after shifting to the postoperarive area.	24 hours
Visual Analogue Scale at Rest (VAS-R)	Visual Analogue Scale at rest (VAS-R) was used to assess Post-operative Pain at rest. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour	24 hours
Visual Analogue Scale on Coughing (VAS-C)	Visual Analogue Scale on Coughing (VAS-C) Was Used to Assess Post-operative Pain on Coughing. Where: 0 = no Pain and 10 = Worst Imaginable Pain. They were Recorded on Shifting to Postoperative and Then at 1, 4, 8, 12, 18 and 24 Hour	24 hours
Short Assessment of Patient Satisfaction Score (SAPS)	Short assessment of patient satisfaction score(SAPS) was assessed on a 5 point scale at the end of 24 hours on the quality of postoperative analgesia. where: highly dissatisfied; dissatisfied; neither dissatisfied nor satisfied; satisfied; highly satisfied	24 hours

Collaborators and Investigators

• Sponsor: Tata Main Hospital
• Investigators: Principal Investigator: Priti Gehlot, DA, Tata Main Hospital, Jamshedpur, India

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: June 9, 2015
• First Submitted That Met QC Criteria: June 15, 2015
• First Posted (Estimate): June 16, 2015

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: 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; Hypnotics and Sedatives; Anesthetics, Local; Dexmedetomidine; Adrenergic Agonists; Ropivacaine
• Other Study ID Numbers: SR9851450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO