Clinical trial NCT03667352: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Condition: Abdominal Bone Flap Cranioplasty; Focus of Study: Perioperative Analgesia
Keywords: Scalp block
Transversus abdominis plane block
Ropivacaine
Clonidine
Lead sponsor: National Institute of Mental Health and Neuro Sciences, India
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference in Postoperative Rescue Analgesia requirement between groups
timeFrame: Measured at 1, 6 and 24 hours postoperatively.
Secondary outcomes:
measure: Difference in intraoperative trend of Heart rate between groups
timeFrame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
measure: Difference in intraoperative trend of Systolic blood pressure between groups
timeFrame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
measure: Difference in intraoperative trend of Diastolic blood pressure between groups
timeFrame: Measured at 10, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes after anaesthesia induction.
measure: Difference in patient reported postoperative pain
timeFrame: Measured at 1, 6 and 24 hours postoperatively.
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Yashoda Hospitals
state: Telangana
Study officials:
References: