A Randomized, Double- Blind, Placebo-Controlled Trial of Pre-emptive Pregabalin on Postoperative pain after Laparoscopic Hysterectomy in Benign Gynecologic disease

Phase 1

• Conditions: Postoperative pain scorePostoperative shoulder painPostoperative quantity of analgesic drug useAdverse effects of pregabalin; Pregabalin; Postoperative pain; Postoperative shoulder pain; Laparoscopic hysterectomy

• Registration Number: TCTR20180507002
• Lead Sponsor: Vajira hospital foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-07
• Study Completion: 2018-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Women ages between 18-60 years old
2. Diagnosis for non-cancerous gynecologic disease
3. ASA class 1 or 2
4. BMI < 35 kg/mm2
5. Non emergency surgery conditions
6. Good data communication

Exclusion Criteria

1. Pregabalin or gabapentin allergy
2. Pregnancy or breast feeding women
3. Pathology indicates cancer
4.Known case of Diabetes mellitus, Hypertension, Kidney diseases, or Diseaes, that associates with nausea/vomitting.
5. Known case of Chronic pain disease.
6. Patients who receive other analgesic drugs, anti-emetic drugs or sedative drugs within 24 hours before operation.
7. Patients who have the active-mental disorders
8.Operation time lasts than 4 hours
9.Any complications from operation, for example massive blood loss, injuries to adjacent organs, wound infection etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain 12 hours after administration of pregabalin/ placebo, maximal point of pain visual analog scale

Secondary Outcome Measures

Name	Time	Method
postoperative pain 6,12, and 24 hour after administration of pregabalin/ placebo visual analog scale,postoperative shoulder pain 6,12, and 24 hours after administration of pregabalin/ placebo visual analog scale,The postoperative quantity of analgesic drug use During 24 hours after administration of pregabalin/ placebo milligrams of fentanyl use by patient controlled analgesia,Adverse effects of pregabalin 48 hours after administration of pregabalin/ placebo Sedation score, nausea/vomitting score