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

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667352
• Other study ID #: DNBT-61/2017
• Status: Completed
• Phase: Phase 4
• Start date: July 15, 2017
• Est. completion date: May 15, 2018

Study information

• Verified date: September 2018
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Unilateral Scalp Block
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.
• Transversus abdominis plane block
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).

Drug:
• Intravenous Fentanyl
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.

Locations

Country	Name	City	State
India	Yashoda Hospitals	Secunderabad	Telangana

Sponsors (1)

Lead Sponsor	Collaborator
Dhritiman Chakrabarti

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.