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
Overview
- Phase
- Phase 4
- Intervention
- Unilateral Scalp Block
- Conditions
- Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
- Sponsor
- Dhritiman Chakrabarti
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Difference in Postoperative Rescue Analgesia requirement between groups
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Dhritiman Chakrabarti
Assistant Professor
National Institute of Mental Health and Neuro Sciences, India
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
Arms & Interventions
Scalp & TAP Block (Group T)
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.
Intervention: Unilateral Scalp Block
Scalp & TAP Block (Group T)
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.
Intervention: Transversus abdominis plane block
Intravenous Fentanyl (Group C)
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: Intravenous Fentanyl
Outcomes
Primary Outcomes
Difference in Postoperative Rescue Analgesia requirement between groups
Time Frame: 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 Outcomes
- 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.)