Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia

NCT06943092 | Completed

• 1 other identifier: FETHA/REC/VOL2/2019/293
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Multimodal analgesic combination of pentazocine-diclofenac has been found to be superior to pentazocine-piroxicam and was associated with a higher level of maternal satisfaction. our study aims to determine the efficacy of piroxicam when compared with diclofenac as pain relief post caesarean section.

Conditions

Analgesia; Post Caserean

Keywords

Pentazocine; Piroxicam; Diclofenac; Post caesarean analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative pain

  This is the post operative pain within the first 24 hours

  24 hours

Study Arms (2)

Piroxicam group

EXPERIMENTAL

Group A received a single dose of intramuscular Piroxicam 20 mg.The first dose was administered immediately after skin closure. Thereafter, this group received intramuscular Pentazocine 30mg 6 hourly for 24 hours.

Drug: Piroxicam group

Diclofenac group

ACTIVE COMPARATOR

Group B received two doses of intramuscular diclofenac 75 mg.The first dose was administered immediately after skin closure and the second dose was administered 12 hours after the first dose. intramuscular Pentazocine 30mg was given 6 hourly for 24 hours.

Drug: Diclofenac group

Interventions

Piroxicam group DRUG

Experimental drug

Piroxicam group

Diclofenac group DRUG

Active drug

Diclofenac group

Eligibility Criteria

• Age: 15 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women carrying live singleton fetusesat 37-42 weeks' gestational age.
• Consentingparturients who had elective caesarean section, under spinal anaesthesia.
• American Society of Anaesthesiologists (ASA) I-II physical status.

You may not qualify if:

• Caesarean sections under general or epidural anesthesia
• Known allergy to Pentazocine, Diclofenacand or Piroxicam
• Patients with uncontrolled hypertension/ pre-eclampsia or eclampsia
• Multiple gestation
• History of peptic ulcer disease,asthma
• Patients with chronic pain or on long term opioids
• Women with dead fetuses or fetuses with congenital abnormalities
• Patients who are unable to rate the pain due to psychiatric illness or illiteracy.
• Parturients with severe obstetric haemorrhage, and sickle cell haemoglobinopathy
• Those that declined consent to participate in the study despite adequate counselling.

Sponsors & Collaborators

• Federal Teaching Hospital Abakaliki: lead

Study Sites (1)

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, 480101, Nigeria

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open label randomised controlled trial

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 24, 2025
• Study Start: January 11, 2020
• Primary Completion: June 8, 2020
• Study Completion: June 8, 2020
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

NG (1)