Dexmedetomidine Versus Fentanyl Plus Bupivacaine for Epidural Analgesia With General Anesthesia for Lumbar Disc Operations

Phase 4

Completed

• Conditions: Anesthesia
• Interventions: Drug: Bupivacaine; Drug: Fentanyl; Drug: Dexmedetomidine

• Registration Number: NCT03438240
• Lead Sponsor: Ain Shams University

Brief Summary

The purpose of this study is to compare addition of dexmedetomidine or fentanyl to bupivacaine for epidural analgesia in combination with general anesthesia in elective lumbar spine operations as regard hemodynamic stability, postoperative pain control and adverse effects.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-02
• Study Start: 2018-02-12
• Study First Submitted: 2018-02-12
• Study First Submitted QC: 2018-02-16
• Study First Posted: 2018-02-19
• Primary Completion: 2018-07-05
• Study Completion: 2018-08-15
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Physical status American Society of Anesthesiologist (ASA) I or II.
• First time elective lumbar dicsectomy or laminectomy

Exclusion Criteria

• Patients who refuse to participate
• Body mass index (BMI) > 30
• Need an emergency lumbar disc operation
• ASA physical status > II
• Major illnesses (e.g. cardiac, respiratory, renal, liver)
• Coagulation abnormalities
• Hypovolemia
• History of increased intracranial pressure
• Convulsions
• Spinal stenosis
• Infection at needle insertion site
• Other contraindications to epidural procedure
• Allergy or contraindications to the drugs used in the study
• History of addiction or alcohol abuse
• Psychiatric illness or mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group BF	Bupivacaine	Bupivacaine plus Fentanyl
Group BF	Fentanyl	Bupivacaine plus Fentanyl
Group BD	Bupivacaine	Bupivacaine plus Dexmedetomidine
Group BD	Dexmedetomidine	Bupivacaine plus Dexmedetomidine

Primary Outcome Measures

Name	Time	Method
First time to analgesic requirement	First 24 hours postoperatively	After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	First 24 hours postoperatively	Total morphine consumption per twenty four hours will be estimated
Visual analogue scale (VAS)	First 24 hours postoperatively	Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt