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

Pre-emptive Pregabalin on Postoperative pain after Laparoscopic Hysterectomy in Benign Gynecologic disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180507002
Enrollment
30
Registered
2018-05-07
Start date
2018-05-08
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain score Postoperative shoulder pain Postoperative quantity of analgesic drug use Adverse effects of pregabalin Pregabalin Postoperative pain Postoperative shoulder pain Laparoscopic hysterectomy

Interventions

A 150 mg pregabalin is given 2 hours before operation,A placebo is given 2 hours before operation
Active Comparator Drug,Placebo Comparator Drug
Pregabalin ,Placebo

Sponsors

Vajira hospital foundation
Lead Sponsor
Vajira hospital foundation
Collaborator

Eligibility

Sex/Gender
Female
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Women ages between 18&#45;60 years old 2. Diagnosis for non&#45;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

Exclusion criteria: 1. Pregabalin or gabapentin allergy 2. Pregnancy or breast feeding women 3. Pathology indicates cancer 4.Known case of Diabetes mellitus&#44; Hypertension&#44; Kidney diseases&#44; or Diseaes&#44; that associates with nausea/vomitting. 5. Known case of Chronic pain disease. 6. Patients who receive other analgesic drugs&#44; anti&#45;emetic drugs or sedative drugs within 24 hours before operation. 7. Patients who have the active&#45;mental disorders 8.Operation time lasts than 4 hours 9.Any complications from operation&#44; for example massive blood loss&#44; injuries to adjacent organs&#44; wound infection etc.

Design outcomes

Primary

MeasureTime frame
postoperative pain 12 hours after administration of pregabalin/ placebo&#44; maximal point of pain visual analog scale

Secondary

MeasureTime frame
postoperative pain 6&#44;12&#44; and 24 hour after administration of pregabalin/ placebo visual analog scale,postoperative shoulder pain 6&#44;12&#44; 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&#44; nausea/vomitting score

Contacts

Public ContactKhemmanat Sanguanwongthong

Obstetrics and Gynecology Department&#44; Faculty of Medicine&#44; Vajira hospital&#44; Navamindradhiraj univers

jobbyhp@gmail.com0818049894

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026