Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia

Efficacy of Piroxicam Versus Diclofenac as Components of Multimodal Analgesic for Post Caesarean Section Analgesia.

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Post Caserean
• Intervention / Treatment: Drug: Piroxicam group; Drug: Diclofenac group

Detailed Description

ABSTRACT Background: Postoperative pain is unavoidable after caesarean section. It constitutes a big challenge to patient's recovery and maternal-infant bonding. The importance of adequate pain control cannot be over emphasized but there is no gold standard for post caesarean section analgesia. A multimodal approach to post caesarean section pain control has been shown to enhance analgesia and reduce side effects but the right combination of analgesics is yet to be determined.

Objective: To compare the efficacy of Pentazocine and Piroxicam versus Pentazocine and Diclofenac for post caesarean section analgesia within first 24 hours.

Method: Eligible participants undergoingelective caesarean section atAlex Ekwueme Federal University Teaching Hospital Abakaliki (AEFUTHA) and St Patrick's Mile 4 Hospital Abakaliki were randomized into two groups, A and B, of 54 participants each using computer generated list of random numbers. Group A receiveda single dose of intramuscular Piroxicam 20mg, while group B received two doses of intramuscular Diclofenac 75mg given 12 hours apart. Participants in both groups also received intramuscular Pentazocine 30mg 6 hourly for 24 hours. The first dose of the drugs was administered immediately after skin closure. The primary outcome measure was control of postoperative painwithin the first 24 hours after caesarean section assessed using visual analogue scale, while the secondary outcome measures were the maternal drug side effects (epigastric pain, nausea etc) and participants' satisfaction. Data obtained was entered into a predesigned sheet and analyzed using Statistical Package for Social Science (IBM SPSS) software (version 24, Chicago II, USA). A difference with a p-value <0.05 was considered statistically significant.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nigeria
  • Ebonyi
    • Abakaliki, Ebonyi, Nigeria, 480101
      • Alex Ekwueme Federal University Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion criteria

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Piroxicam group; 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; Experimental drug
Active Comparator: Diclofenac group; 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; Active drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	This is the post operative pain within the first 24 hours	24 hours

Collaborators and Investigators

• Sponsor: Federal Teaching Hospital Abakaliki

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2020
• Primary Completion (Actual): June 8, 2020
• Study Completion (Actual): June 8, 2020

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 22, 2025
• First Posted (Actual): April 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Diclofenac; Piroxicam; Pentazocine; Post caesarean analgesia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Diclofenac; Piroxicam
• Other Study ID Numbers: FETHA/REC/VOL2/2019/293

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This will be following publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No