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

Phase 4

Completed

• Conditions: Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
• Interventions: Procedure: Unilateral Scalp Block; Drug: Intravenous Fentanyl; Procedure: Transversus abdominis plane block

• Registration Number: NCT03667352
• Lead Sponsor: Dhritiman Chakrabarti

Brief Summary

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

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 Timeline

• Study Start: 2017-07-15
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Status Verified: 2018-09
• Study First Submitted: 2018-09-10
• Study First Submitted QC: 2018-09-10
• Study First Posted: 2018-09-12
• Last Update Submitted: 2018-09-12
• Last Update Posted: 2018-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Patients undergoing Abdominal bone flap replacement.

Exclusion Criteria

1. Motor and comprehensive aphasia,
2. Disoriented mental state or Inability to follow commands.
3. Hypersensitivity to amide local anesthetics,
4. Bone flap site infection
5. Coagulation disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scalp & TAP Block (Group T)	Unilateral Scalp Block	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.
Scalp & TAP Block (Group T)	Transversus abdominis plane block	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.
Intravenous Fentanyl (Group C)	Intravenous Fentanyl	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.

Primary Outcome Measures

Name	Time	Method
Difference in Postoperative Rescue Analgesia requirement between groups	Measured at 1, 6 and 24 hours postoperatively.	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.

Secondary Outcome Measures

Name	Time	Method
Difference in intraoperative trend of Heart rate between groups	Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.	Heart rate measured intraoperatively will be compared between the groups.
Difference in intraoperative trend of Systolic blood pressure between groups	Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.	Systolic blood pressure measured intraoperatively will be compared between the groups.
Difference in intraoperative trend of Diastolic blood pressure between groups	Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.	Diastolic blood pressure measured intraoperatively will be compared between the groups.
Difference in patient reported postoperative pain	Measured at 1, 6 and 24 hours postoperatively.	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.

Trial Locations

Locations (1)

Yashoda Hospitals; 🇮🇳 Secunderabad, Telangana, India