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

Dhritiman Chakrabarti

Status and phase: Completed; Phase 4

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

Treatments: Drug: Intravenous Fentanyl; Procedure: Unilateral Scalp Block; Procedure: Transversus abdominis plane block

Study type: Interventional

Funder types: Other

Identifiers

NCT03667352

DNBT-61/2017

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Scalp & TAP Block (Group T)

Experimental group

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.

Treatment:

Procedure: Transversus abdominis plane block

Procedure: Unilateral Scalp Block

Intravenous Fentanyl (Group C)

Active Comparator group

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.

Treatment:

Drug: Intravenous Fentanyl