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

Study Overview
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Brief Summary
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This study assesses efficacy of scalp block and Ultrasound guided transverse abdominis plane (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 (ABFC).

Detailed Description
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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.

Official Title
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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

Conditions
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Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia

Intervention / Treatment
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* Procedure: Unilateral Scalp Block
* Procedure: Transversus abdominis plane block
* Drug: Intravenous Fentanyl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scalp & TAP Block (Group T)<br>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. | Procedure: Unilateral Scalp Block<br>* 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.<br>Procedure: Transversus abdominis plane block<br>* 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).<br>* Other names: TAP block;|
| Active Comparator: Intravenous Fentanyl (Group C)<br>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. | Drug: Intravenous Fentanyl<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Postoperative Rescue Analgesia requirement between groups | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in intraoperative trend of Heart rate between groups | Heart rate measured intraoperatively will be compared between the groups. | Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction. | 
| Difference in intraoperative trend of Systolic blood pressure between groups | Systolic blood pressure measured intraoperatively will be compared between the groups. | Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction. | 
| Difference in intraoperative trend of Diastolic blood pressure between groups | Diastolic blood pressure measured intraoperatively will be compared between the groups. | Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction. | 
| Difference in patient reported postoperative pain | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Scalp block, Transversus abdominis plane block, Ropivacaine, Clonidine