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

Ain Shams University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Anesthesia

Interventions

BupivacaineDRUG

patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%

FentanylDRUG

Plus 50 µg fentanyl

DexmedetomidineDRUG

Plus 50 µg dexmedetomidine

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Ain Shams University hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

First time to analgesic requirement

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.

Time frame: First 24 hours postoperatively

Secondary Outcomes

Total opioid consumption

Total morphine consumption per twenty four hours will be estimated

Time frame: First 24 hours postoperatively

Visual analogue scale (VAS)

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

Time frame: First 24 hours postoperatively

Data from ClinicalTrials.gov

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