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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: Pregabalin; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02285010

Si594/2014

Details and patient eligibility

About

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

Full description

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo in capsule is prescribed to the patient 60 min prior to the surgery.

Treatment:

Drug: placebo

Pregabalin

Active Comparator group

Description:

Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.

Treatment:

Drug: Pregabalin