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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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Unilateral Scalp Block
Transversus abdominis plane block
Intravenous Fentanyl
Sponsored by
Dhritiman Chakrabarti
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia focused on measuring Scalp block, Transversus abdominis plane block, Ropivacaine, Clonidine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yashoda Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scalp & TAP Block (Group T)

Intravenous Fentanyl (Group C)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Difference in intraoperative trend of Heart rate between groups
Heart rate measured intraoperatively will be compared between the groups.
Difference in intraoperative trend of Systolic blood pressure between groups
Systolic blood pressure measured intraoperatively will be compared between the groups.
Difference in intraoperative trend of Diastolic blood pressure between groups
Diastolic blood pressure measured intraoperatively will be compared between the groups.
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.

Full Information

First Posted
September 10, 2018
Last Updated
September 12, 2018
Sponsor
Dhritiman Chakrabarti
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1. Study Identification

Unique Protocol Identification Number
NCT03667352
Brief Title
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
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 15, 2017 (Actual)
Primary Completion Date
May 15, 2018 (Actual)
Study Completion Date
May 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dhritiman Chakrabarti

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
Keywords
Scalp block, Transversus abdominis plane block, Ropivacaine, Clonidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scalp & TAP Block (Group T)
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous Fentanyl (Group C)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Unilateral Scalp Block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plane block
Other Intervention Name(s)
TAP block
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Intravenous Fentanyl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in Postoperative Rescue Analgesia requirement between groups
Description
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.
Time Frame
Measured at 1, 6 and 24 hours postoperatively.
Secondary Outcome Measure Information:
Title
Difference in intraoperative trend of Heart rate between groups
Description
Heart rate measured intraoperatively will be compared between the groups.
Time Frame
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Title
Difference in intraoperative trend of Systolic blood pressure between groups
Description
Systolic blood pressure measured intraoperatively will be compared between the groups.
Time Frame
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Title
Difference in intraoperative trend of Diastolic blood pressure between groups
Description
Diastolic blood pressure measured intraoperatively will be compared between the groups.
Time Frame
Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
Title
Difference in patient reported postoperative pain
Description
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.
Time Frame
Measured at 1, 6 and 24 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Yashoda Hospitals
City
Secunderabad
State/Province
Telangana
ZIP/Postal Code
500003
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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