- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03667352
Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties
Efficacy Of Scalp Block And Ultrasound Guided TAP Block With Clonidine As Adjuvant To Ropivacaine Versus Intravenous Fentanyl On Intraoperative Hemodynamics And Perioperative Analgesia In Abdominal Bone Flap Cranioplasties: A Prospective, Randomised, Double Blind Study
Study Overview
Status
Intervention / Treatment
Detailed Description
Scalp blocks with local anaesthetic agents along with general anaesthesia provides intraoperative and postoperative analgesia by blunting the hemodynamic responses to noxious stimuli. The transversus abdominis plane "TAP" block, a regional anaesthesia technique that provides analgesia following abdominal surgery. It involves a single large bolus injection of local anaesthetic into an anatomical space between the internal oblique and transversus abdominis muscles.
Ropivacaine is less cardio toxic, less arrhythmogenic, less toxic to central nervous system (CNS) than bupivacaine, and it also has intrinsic vasoconstrictor property. Clonidine is an alpha-2 receptor agonist, which has a known property of reducing requirement of analgesics in the perioperative period.
This study aimed to assess the efficacy of scalp block and TAP block with 1µg/kg clonidine as adjuvant to 0.2% ropivacaine versus intravenous fentanyl (0.1µg/kg/hr) on intraoperative hemodynamics and perioperative analgesia in abdominal bone flap cranioplasties.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Telangana
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Secunderabad, Telangana, India, 500003
- Yashoda Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients undergoing Abdominal bone flap replacement.
Exclusion Criteria:
- Motor and comprehensive aphasia,
- Disoriented mental state or Inability to follow commands.
- Hypersensitivity to amide local anesthetics,
- Bone flap site infection
- Coagulation disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Scalp & TAP Block (Group T)
Group T received 0.2% Ropivacaine + clonidine 1µg/kg mixture, for ipsilateral scalp block (10ml),TAP block under USG guidance (20ml) and intravenous saline 0.1ml/kg/hr (sham infusion) for continuous infusion.
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Scalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves.
The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1).
It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study).
Other Names:
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Active Comparator: Intravenous Fentanyl (Group C)
Group C received saline, for ipsilateral scalp block (10ml) and TAP block under USG guidance (20ml) and I.V fentanyl 1 µg/kg/hr as analgesic.
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Fentanyl is a commonly used opioid drug administered for analgesia in the perioperative period.
It may be used as either intermittent bolus administration or continuous infusion or a combination of the two.
Usual infusion doses range from 1-2 microgram/kg/hr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in Postoperative Rescue Analgesia requirement between groups
Time Frame: Measured at 1, 6 and 24 hours postoperatively.
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Postoperative rescue analgesia (Inj. paracetamol 1gm I.V) if patient reported pain measured by visual analogue score was ≥ 4. Visual analogue scale (VAS) is a self reported score for estimation of pain which ranges between 1 (no pain) to 10 (worst possible pain). VAS score interpretation: No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10. |
Measured at 1, 6 and 24 hours postoperatively.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in intraoperative trend of Heart rate between groups
Time Frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Heart rate measured intraoperatively will be compared between the groups.
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Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Difference in intraoperative trend of Systolic blood pressure between groups
Time Frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Systolic blood pressure measured intraoperatively will be compared between the groups.
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Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Difference in intraoperative trend of Diastolic blood pressure between groups
Time Frame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Diastolic blood pressure measured intraoperatively will be compared between the groups.
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Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
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Difference in patient reported postoperative pain
Time Frame: Measured at 1, 6 and 24 hours postoperatively.
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Postoperative pain measured by measured by visual analogue scoring system (VAS). Range: 1-10. No pain - 1, Mild pain <4, Moderate pain 4-7, Severe pain >7, Worst possible pain =10. |
Measured at 1, 6 and 24 hours postoperatively.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Perceptual Disorders
- Agnosia
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Fentanyl
Other Study ID Numbers
- DNBT-61/2017
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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