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

NCT03667352 | Completed Phase 4

• 1 other identifier: DNBT-61/2017
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Scalp block; Transversus abdominis plane block; Ropivacaine; Clonidine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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.

• 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.

• 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.

• Difference in patient reported postoperative pain

  Measured at 1, 6 and 24 hours postoperatively.

Study Arms (2)

Scalp & TAP Block (Group T)

EXPERIMENTAL

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; Procedure: Transversus abdominis plane block

Intravenous Fentanyl (Group C)

ACTIVE COMPARATOR

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

Interventions

Unilateral Scalp Block PROCEDURE

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.

Scalp & TAP Block (Group T)

Transversus abdominis plane block PROCEDURE

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).

Also known as: TAP block

Scalp & TAP Block (Group T)

Intravenous Fentanyl DRUG

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.

Intravenous Fentanyl (Group C)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Abdominal bone flap replacement.

You may not qualify if:

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

Sponsors & Collaborators

• Dhritiman Chakrabarti: lead

Study Sites (1)

Yashoda Hospitals

Secunderabad, Telangana, 500003, India

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: July 15, 2017
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: September 14, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)