AnalgesiaNCT06943092
Piroxicam Versus Diclofenac for Post Caesarean Section Analgesia
A study testing Piroxicam group and Diclofenac group in people with Analgesia and Post Caserean, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Post Caserean
- What is being tested?
- Piroxicam group and Diclofenac group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteNigeria
- Study dates
- 11 Jan 2020to 8 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site
Alex Ekwueme Federal University Teaching Hospital
Abakaliki, Ebonyi State, 480101
About this study
Official title: 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.
Read the 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
- Being tested
- Piroxicam group, Diclofenac group
- Keywords
- Pentazocine, Piroxicam, Diclofenac, Post caesarean analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroxicam groupDrug
Experimental drug
Diclofenac groupDrug
Active drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Diclofenac group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
This is the post operative pain within the first 24 hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2025
- Study start11 Jan 2020
- Primary completion8 Jun 2020
- Study completion8 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Teaching Hospital Abakaliki
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06943092
- Sponsor's protocol ID
- FETHA/REC/VOL2/2019/293
- Status last verified
- Apr 2025
- First submitted
- 14 Apr 2025
- Last updated
- 24 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This will be following publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Piroxicam Versus Diclofenac as Components of Multimodal Analgesic for Post Caesarean Section Analgesia.
- ClinicalTrials.gov ID
- NCT06943092
- Acronym / sponsor ID
- FETHA/REC/VOL2/2019/293
- Conditions
- Analgesia, Post Caserean
- Keywords
- Pentazocine, Piroxicam, Diclofenac, Post caesarean analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Federal Teaching Hospital AbakalikiOther government
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 8 Jun 2020 (actual)
- Study completion
- 8 Jun 2020 (actual)
- First posted
- 24 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Piroxicam group | Experimental | Drug: Piroxicam groupGroup 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. |
| Diclofenac group | Active comparator | Drug: Diclofenac groupGroup 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piroxicam groupExperimental drug | Drug | Piroxicam group |
| Diclofenac groupActive drug | Drug | Diclofenac group |
Primary outcome
Postoperative pain
Time frame: 24 hours
This is the post operative pain within the first 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: No. This will be following publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piroxicam group and Diclofenac group in people with Analgesia and Post Caserean, run by Federal Teaching Hospital Abakaliki at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.