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Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

R

Rajavithi Hospital

Status and phase

Completed
Phase 4

Conditions

Cesarean Delivery

Treatments

Drug: Bupivacaine
Drug: Diclofenac

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

120 patients

Sex

Female

Ages

20 to 50 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

120 participants in 2 patient groups

Group Bupivacaine
Experimental group
Description:
0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
Treatment:
Drug: Bupivacaine
Group Diclofenac
Active Comparator group
Description:
diclofenac 75 mg intramuscular, 2 hours postoperation
Treatment:
Drug: Diclofenac

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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