PainreliefNCT06845930
Rectal Versus Intramuscular Diclofenac for Pain Relief Following Caesarean Section
A study testing Rectal Diclofenac and Intramuscular diclofenac in people with Painrelief and Postoperative, run by Assumpta Nnenna Nweke at 1 site in Nigeria.
Trial summary
Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Painrelief, Postoperative
- What is being tested?
- Rectal Diclofenac and Intramuscular diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNigeria
- Study dates
- 19 Apr 2021to 18 Sep 2021
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Elective caesarean section at term with spinal anaesthesia;E
Who cannot join
- Allergy to NSAIDS
- Bleeding diathesis
- Use of general anesthesia
- Chronic liver disease
- History of renal disease
- Asthma in pregnancy
Show all 11Show fewer
- Emergency Cesarean section
- Morbid obesity
- Sickle cell anaemia patients
- Hypertensive disorders of pregnancy
- Refusal to give consent
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: Rectal Versus Intramuscular Diclofenac for Pain Relief Following Elective Caesarean Section at Alex Ekwueme Federal University Teaching Hospital Abakaliki: A Randomized Controlled Trial
Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Read the detailed description
Background: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Aim: This study is designed to compare the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.
Methods: This was a randomized equivalence controlled trial conducted among pregnant women booked for elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital Abakaliki, comparing the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective caesarean section at term. One arm received 100mg of suppository diclofenac and the other arm received 75mg of intramuscular diclofenac. These doses were repeated every 12hours for 24 hours. Pain scoring was done at 1, 6, 12, 18 and 24 hours after administration of the drugs. The data obtained was analysed using IBM SPSS software (version 23, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be statistically significant.
- Conditions
- Painrelief, Postoperative
- Being tested
- Rectal Diclofenac, Intramuscular diclofenac
- Keywords
- Rectal diclofenac, Caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal DiclofenacDrug
Rectal diclofenac, 100mg administered immediately after skin closure then 12 hourly for 24 hours.
Intramuscular diclofenacDrug
Intramuscular diclofenac, 7mg administered immediately after skin closure then 12 hourly for 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Rectal diclofenac | Experimental | Participants had 100mg of rectal diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. Receives: Drug: Rectal Diclofenac |
| Intramuscular diclofenac | Active comparator | Participants had 75mg of intramuscular diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. Receives: Drug: Intramuscular diclofenac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score after the administration of the rectal and intramuscular diclofenac
Pain score at different intervals with either rectal or intramuscular diclofenac immediately after skin closure. This pain assessment was done with visual analogue scale ranging from 0 to 10. zero represents no pai while ten represents the worst possible pain.
Measured: 24 hours after the last dose
Secondary outcomes (1)
maternal side effects and need for additional analgesia
Number of participants with local irritation at the site of injection or insertion of drug,headache,dizziness and loss of appetite. a Also the number of participants requiring additional analgesia
Measured: 24 hours after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start19 Apr 2021
- Primary completion18 Sep 2021
- Study completion18 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainreliefStudies 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 randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assumpta Nnenna Nweke
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Assumpta Nnenna Nweke, Federal Teaching Hospital Abakaliki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845930
- Sponsor's protocol ID
- AEFUTHA/REC/VOL 3/2020/038
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Versus Intramuscular Diclofenac for Pain Relief Following Elective Caesarean Section at Alex Ekwueme Federal University Teaching Hospital Abakaliki: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06845930
- Acronym / sponsor ID
- AEFUTHA/REC/VOL 3/2020/038
- Conditions
- Painrelief, Postoperative
- Keywords
- Rectal diclofenac, Caesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assumpta Nnenna NwekeOther government
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 18 Sep 2021 (actual)
- Study completion
- 18 Sep 2021 (actual)
- First posted
- 25 Feb 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.
Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Detailed description
Background: Caesarean section (CS) is one of the commonest major Obstetric surgeries worldwide and its rate has markedly increased globally. Pain control is an integral part of enhancement of recovery after caesarean section and NSAIDs have been used in combination with opioids for post-operative pain management in recent times. There are sparse data on maternal satisfaction with suppository diclofenac or any data from our centre that compared the intramuscular and rectal routes of diclofenac administration. Hence this study was conceived to compare the efficacy of rectal diclofenac and intramuscular diclofenac as an adjunct to intramuscular pentazocine in the management of post-operative pain in women who have elective caesarean section.
Aim: This study is designed to compare the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital, Abakaliki.
Methods: This was a randomized equivalence controlled trial conducted among pregnant women booked for elective Caesarean section at Alex-Ekwueme Federal University Teaching Hospital Abakaliki, comparing the efficacy of rectal diclofenac with that of intramuscular diclofenac as pain relief among women after elective caesarean section at term. One arm received 100mg of suppository diclofenac and the other arm received 75mg of intramuscular diclofenac. These doses were repeated every 12hours for 24 hours. Pain scoring was done at 1, 6, 12, 18 and 24 hours after administration of the drugs. The data obtained was analysed using IBM SPSS software (version 23, Chicago II, USA) and the intention to treat concept. A difference with a P value of ≤ 0.05 was taken to be 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 randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Rectal diclofenac | Experimental | Drug: Rectal DiclofenacParticipants had 100mg of rectal diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. |
| Intramuscular diclofenac | Active comparator | Drug: Intramuscular diclofenacParticipants had 75mg of intramuscular diclofenac administered immediately after skin closure by the researcher. The medication was repeated every 12hourly for 24 hours. For all the participants, 30 mg pentazocine was given intramuscularly every 6 hours for 24 hours. |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Elective caesarean section at term with spinal anaesthesia;E
Key exclusion criteria (11 listed)
- Allergy to NSAIDS
- Bleeding diathesis
- Use of general anesthesia
- Chronic liver disease
- History of renal disease
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 |
|---|---|---|
| Rectal DiclofenacRectal diclofenac, 100mg administered immediately after skin closure then 12 hourly for 24 hours. | Drug | Rectal diclofenac |
| Intramuscular diclofenacIntramuscular diclofenac, 7mg administered immediately after skin closure then 12 hourly for 24 hours. | Drug | Intramuscular diclofenac |
Primary outcome
Pain score after the administration of the rectal and intramuscular diclofenac
Time frame: 24 hours after the last dose
Pain score at different intervals with either rectal or intramuscular diclofenac immediately after skin closure. This pain assessment was done with visual analogue scale ranging from 0 to 10. zero represents no pai while ten represents the worst possible pain.
1 secondary outcome
maternal side effects and need for additional analgesia
Time frame: 24 hours after the last dose
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 25 Feb 2025.
- Individual participant dataSharing planned: No
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 Rectal Diclofenac and Intramuscular diclofenac in people with Painrelief and Postoperative, run by Assumpta Nnenna Nweke 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 1 inclusion and 11 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 25 Feb 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?
Pain score after the administration of the rectal and intramuscular diclofenac (time frame: 24 hours after the last dose). 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 25 Feb 2025.