Effect of Pregabalin on Post Operative Pain in Abdominal Hysterectomy Under Spinal Anesthesia With Intrathecal Morphine

Mahidol University125 enrolled

Overview

This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.

The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

125

Conditions

Post Operative Pain

Interventions

placeboDRUG

Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

PregabalinDRUG

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine 2. Patient can use patient-controlled analgesia (IV PCA) Exclusion Criteria: 1. History of drug allergy to gabapentinoid and related drug 2. History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient 3. Renal disease (Creatinine Clearance \< 60), Liver disease, Seizure disorder and Psychiatric disorder

Locations (1)

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Outcomes

Primary Outcomes

Post Operative Morphine Consumption

Cumulative morphine consumption in the first 24 hours is recorded from IV PCA

Time frame: 6, 12, and 24 hours after operation

Secondary Outcomes

Time to First Analgesia

Time to first analgesia is recorded from IV PCA.

Time frame: 24 hours

Pain Scores on the Visual Analog Scale

Pain score is evaluated by nurses using Numerical Rating Scale (NRS) Minimum score 0 (no pain), Maximum score 10 (worst imaginable pain), lower scores mean a better outcome

Time frame: 24 hours

Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability

Measure sedation score by evaluate and observe; measure pruritus, PONV, dizziness, visual disturbance using questionnaire

Time frame: 24 hours

Number of Patients Evaluating Their Satisfaction

Using four-point scale to evaluate patient satisfaction. Patients indicated if their satisfaction was Unsatisfied, Less Satisfied, Moderately Satisfied, or Good Satisfied.

Time frame: 24 hours

Data from ClinicalTrials.gov

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