Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia

NCT ID: NCT06943092

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-11
• Study Completion Date: 2020-06-08

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.

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.

Conditions

Analgesia; Post Caserean

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Piroxicam group

Intervention Type: DRUG

Experimental drug

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.

Group Type: ACTIVE_COMPARATOR

Diclofenac group

Intervention Type: DRUG

Active drug

Interventions

Piroxicam group

Experimental drug

Intervention Type: DRUG

Diclofenac group

Active drug

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Teaching Hospital Abakaliki

OTHER_GOV

Sponsor Role: lead

Responsible Party

Assumpta Nnenna Nweke

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Alex Ekwueme Federal University Teaching Hospital

Abakaliki, Ebonyi State, Nigeria

Countries

Nigeria

Other Identifiers

FETHA/REC/VOL2/2019/293

Identifier Type: -

Identifier Source: org_study_id