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OpenTrials
Completed

NCT Number: NCT03259243

Comparison of Efficacy of Bupivacaine for Relief Postoperative Pain in Women Undergoing Laparoscopic Gynecologic Surgery

To comparison of efficacy of Bupivacaine for relief postoperative pain in women undergoing laparoscopic gynecologic surgery

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Waetasleem Chema

Bangkok, 10400, Thailand

About this study

Gynecologic laparoscopic procedures have become more common nowadays because of their benefits in less tissue trauma, less perioperative morbidity and shorter hospital stays compared with laparotomy. But postoperative pain still be the most concerning problems including discomfort at incision sites, Pain due to pneumoperitoneum stretching the intraabdominal cavity and dissection of the abdominal and pelvic viscera.

Visceral pain is at maximal intensity during the first postoperative hours and is exacerbated by coughing, respiratory movements, and mobilization. Because the pain comprises of several factors, multimodal analgesic techniques are needed for effective postoperative analgesia and brought to this study to compare efficacy of Bupivacaine for pain relief postoperatively in women undergoing gynecologic laparoscopic surgery divided into 4 groups including preincision and preclosure Bupivacaine injection collated with placebo group. The result is measurement in postoperative pain score and amount of drug that using to reduce pain

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patient who undergoing gynecologic laparoscopic surgery
  • Patient who agrees to participate in this study
  • Patient able to speak and understand Thai
  • Patient able to complete the questionnaire

Exclusion criteria

  • Patient with history of allergy in any kind anesthetic drug
  • Patient who pregnant
  • Patient who sign for single port gynecologic laparoscopic surgery or NOTE surgery
  • Patient whom the surgery is withhold or canceled
  • Patient whom the surgery is converted to laparotomy

Treatment and study plan

Bupivacaine Hydrochloride

Drug

0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection

Other names: 0.5% Marcaine

Primary outcomes

  1. Postoperative pain after surgery

    Time frame: 24-48 hours after surgery

    Postoperative pain score in intervention and placebo groups

Secondary outcomes

  1. Among of pethidine use

    Time frame: within 48 hours

    Among of pethidine use to reduced postoperative pain

  2. Duration of hospital stay

    Time frame: within 7 days

    Duration of hospital stay after surgery

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

Port Site Infiltration With Bupivacaine for Reduction of Postoperative Pain in Woman Undergoing Gynecologic Laparoscopy: A Randomized, Factorial, Double-Blind, Controlled Trial

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 23, 2017
Registry last updated
Oct 22, 2020

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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