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NCT Number: NCT03039426

Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection

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Key information

Conditions

Cesarean Delivery

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Natthida Mekwongtrakarn, Bangkok, Thailand

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About this study

Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017
  • Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor
  • Pregnant women more than 20 years of age
  • Gestational age more than 37 week
  • Cesarean section under regional or general anesthesia
  • Ability to communicating, writing and reading Thai language

Exclusion criteria

  • Inability to communicating or writing or reading Thai language
  • Contraindicated to bupivacaine or diclofenac or morphine
  • Pregnant women with emergency conditions
  • Have one or more complication of pregnancy
  • Intraoperative arrhythmia
  • Pregnant women less than 20 years of age
  • Regional anesthesia with morphine

Treatment and study plan

Bupivacaine

Drug

0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration

Diclofenac

Drug

diclofenac 75 mg intramuscular, 2 hours postoperation

Primary outcomes

  1. Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale

    Time frame: 2, 6 and 24 hours post-operation

  2. Compared rescued dose of morphine injection

    Time frame: Within 24 hours post-operation

Sponsors and collaborators

Lead sponsor

Department of Medical Services Ministry of Public Health of Thailand

Other Gov

Registry information

Official study title

A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 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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