Clinical trial NCT06943092: Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia
Official title: Efficacy of Piroxicam Versus Diclofenac as Components of Multimodal Analgesic for Post Caesarean Section Analgesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Post Caserean
Keywords: Pentazocine
Piroxicam
Diclofenac
Post caesarean analgesia
Lead sponsor: Federal Teaching Hospital Abakaliki
Sponsor class: OTHER_GOV
First posted: 2025-04-24
Enrollment: 108
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open label randomised controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Postoperative pain
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Abakaliki
country: Nigeria
facility: Alex Ekwueme Federal University Teaching Hospital
state: Ebonyi
Study officials:
References: