Dexmedetomidine as an Adjuvant to Bupivacaine in Scalp Block Versus Bupivacaine Alone for Postoperative Pain Management in Patients Undergoing Craniotomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Cumulative postoperative morphine consumption
Study Overview
Brief Summary
This study aims to compare dexmedetomidine as an adjuvant to bupivacaine in scalp block versus bupivacaine alone for postoperative pain management in patients undergoing craniotomy.
Detailed Description
Scalp block is proposed as a multimodal approach to preventing postoperative pain and hemodynamic responses to previous noxious stimulation during the operation.
The use of adjuvants, such as dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, has recently been studied for its analgesic effects. Dexmedetomidine acts additionally to local anesthetics, prolonging their duration of action.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age from 18 to 65 years.
- •Both sexes.
- •American Society of Anesthesiologists (ASA) physical status I or II.
- •Undergoing supratentorial elective planned craniotomies.
Exclusion Criteria
- •Patients refusal.
- •History of known allergy to the used local anesthetic or dexmedetomidine.
- •Bleeding disorders.
- •Evidence of local infection at the site of injection.
- •Emergency craniotomy.
- •Psychotic disorder.
- •Patients who will not be extubated in the operating room after surgery.
Arms & Interventions
Group SB
Patients will receive a scalp block with bupivacaine alone.
Intervention: Scalp block (Other)
Group SD
Patients will receive a scalp block with dexmedetomidine as an adjuvant to bupivacaine.
Intervention: Scalp block + Dexmedetomidine (Other)
Outcomes
Primary Outcomes
Cumulative postoperative morphine consumption
Time Frame: 24 hours postoperatively
If the Visual Analogue Scale (VAS) score is ≥3, rescue analgesia will be administered; intravenous morphine will be given at a dose of 0.05 mg/kg
Secondary Outcomes
- Time for 1st rescue analgesia(24 hours postoperatively)
- Incidence of complications(24 hours postoperatively)
- Heart rate(24 hours postoperatively)
- Mean arterial pressure(24 hours postoperatively)
- Degree of pain(24 hours postoperatively)
Investigators
Omar Ahmed Zakaria Khiralla
Resident of Anaesthesia, Intensive Care Unit and Pain, Faculty of Medicine, Ain shams University, Cairo, Egypt.
Ain Shams University