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Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

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ClinicalTrials.gov Identifier: NCT03039426
Recruitment Status : Unknown
Verified October 2017 by Rajavithi Hospital.
Recruitment status was:  Recruiting
First Posted : February 1, 2017
Last Update Posted : October 10, 2017
Sponsor:
Information provided by (Responsible Party):
Rajavithi Hospital

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

Condition or disease Intervention/treatment Phase
Cesarean Delivery Drug: Bupivacaine Drug: Diclofenac Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : June 30, 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Experimental: Group Bupivacaine
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Drug: Bupivacaine
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration

Active Comparator: Group Diclofenac
diclofenac 75 mg intramuscular, 2 hours postoperation
Drug: Diclofenac
diclofenac 75 mg intramuscular, 2 hours postoperation




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039426


Locations
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Thailand
Natthida Mekwongtrakarn Not yet recruiting
Bangkok, Thailand, 10400
Contact: Natthida Mekwongtrakarn, MD    +66812588470    m_natthida@hotmail.com   
Contact: Suphet Tuipae, MD    +66812588470    m_natthida@hotmail.com   
Rajavithi Hospital Recruiting
Bangkok, Thailand
Contact: Rajavithi Hospital    +6623548108    m_natthida@hotmail.com   
Sponsors and Collaborators
Rajavithi Hospital

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Responsible Party: Rajavithi Hospital
ClinicalTrials.gov Identifier: NCT03039426     History of Changes
Other Study ID Numbers: RJBUPI
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: October 10, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diclofenac
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action