Dexmedetomine vs Dexamethasone in TAB Block for Abdominal Surgries

Phase 4

• Conditions: Anesthesia
• Interventions: Drug: Dexmedetomidine

• Registration Number: NCT05323565
• Lead Sponsor: Ain Shams University

Brief Summary

Randomized controlled clinical Trial to compare the efficacy and duration of postoperative analgesia achieved after adding dexmedetomidine or dexamethasone to bupivacaine in TAP block for lower open abdominal surgeries.

Detailed Description

A Comparative study between the use of dexmedetomidine versus dexamethasone as adjuvant to bupivacaine in ultrasound-guided transversus abdominis plane block for post-operative pain relief in patients undergoing lower open abdominal surgeries

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-01
• Study First Submitted: 2022-04-05
• Study First Submitted QC: 2022-04-11
• Last Update Submitted: 2022-04-11
• Study First Posted: 2022-04-12
• Last Update Posted: 2022-04-12
• Primary Completion: 2022-07-01
• Study Completion: 2022-07-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Adult patients, Age 20-60 years. Elective operation under general anesthesia. Physical Status: ASA I and II Patients. Body mass index 25-35 kg/m2.

Exclusion Criteria

• Infection at site of injection.
• Patient refusal.
• Psychiatric or physical illness that lead to inability to cooperate, speak or read.
• Abdominal operations under spinal anesthesia.
• History or evidence of coagulopathy.
• Known allergies to drugs used .
• Preexisting neurological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A (n=15): (Dexamethasone group)	Dexmedetomidine	Patients will receive 20 ml 0.25% bupivacaine plus 4 mg dexamethasone on each side TAB bock.
Group C (n=15): (control group)	Dexmedetomidine	Patients will receive 20 ml 0.25% bupivacaine on each side TAB block.
Group B (n=15): (Dexmedetomidine group)	Dexmedetomidine	Patients will receive 20 ml 0.25% bupivacaine plus 0.5 mcg/kg of dexmedetomidine on each side TAB block.

Primary Outcome Measures

Name	Time	Method
1st time for rescue analgesia	first 24 hours post-operatively	Time to first analgesia requirment(starting from drug injection)

Secondary Outcome Measures

Name	Time	Method
Pain score- Visual Analogue Score (VAS)	First 24 hours post-operatively.	It ranges from 0 indicating no pain till 10 indicating severe intolerable pain with variable degrees of ascending pain in between\] was assessed at 0 min (AT PACU), 2hr,6 hr, 12 hr, 18 hr, and 24 hr postoperatively.

Trial Locations

Locations (1)

Ain Shams University, Faculty of medicine; 🇪🇬 Cairo, Egypt