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NCT Number: NCT02285010

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

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

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Key information

Conditions

Post Operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
  • Patient can use patient-controlled analgesia (IV PCA)

Exclusion criteria

  • History of drug allergy to gabapentinoid and related drug
  • History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
  • Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder

Treatment and study plan

Placebo

Drug

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.

Pregabalin

Drug

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.

Other names: Lyrica

Primary outcomes

  1. Post Operative Morphine Consumption

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

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

Secondary outcomes

  1. Time to First Analgesia

    Time frame: 24 hours

    Time to first analgesia is recorded from IV PCA.

  2. Pain Scores on the Visual Analog Scale

    Time frame: 24 hours

    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

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

    Time frame: 24 hours

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

  4. Number of Patients Evaluating Their Satisfaction

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Official study title

Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Nov 6, 2014
Registry last updated
Mar 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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