Cesarean Section PainNCT04538391
Intra Incisional Infiltration of Bupivacaine Versus Meloxicam on Post Cesarean Section Pain Relief
A study of Cesarean Section Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Pain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Mar 2019to 9 May 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 21-40 years
- Elective C.S at term
- Patient having no medical disorders
- Patient with no obstetrical complications
Who cannot join
- extreme of reproductive age
- allergy to local anesthetic infiltration agent
- any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
- refusal to participate in the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief
Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.
Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
Read the detailed description
study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020
- Conditions
- Cesarean Section Pain
- Being tested
- local ifiltration Bupivacaine, Meloxican and placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local ifiltration Bupivacaine, Meloxican and placeboDrug
no other intervention done
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Active comparator | included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. Receives: Drug: local ifiltration Bupivacaine, Meloxican and placebo |
| meloxicam group | Active comparator | included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. Receives: Drug: local ifiltration Bupivacaine, Meloxican and placebo |
| placebo group | Active comparator | included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline. Receives: Drug: local ifiltration Bupivacaine, Meloxican and placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores
Assessment of pain scores after Cesarean section
Measured: immediately after the intervention
Postoperative analgesic requirements
Assessment of Postoperative analgesic requirements
Measured: immediately after the intervention
time of first dose of analgesia
Determination of time of first dose of analgesia
Measured: immediately after the intervention
Secondary outcomes (4)
Postoperative fever
Assessment of Postoperative fever
Measured: immediately after the intervention
onset of mobilization
Assessment of onset of mobilization
Measured: immediately after the intervention
side effects of medications
Assessment of side effects of medications
Measured: immediately after the intervention
Pain assessment by visual analogue scale
Post-operative pain assessment was done using a 10-point visual analogue scale
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start3 Mar 2019
- Primary completion5 Mar 2020
- Study completion9 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section PainStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group A (bupivacaine group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. Group B (meloxicam group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsibai Anter, Menoufia Obstetrics and Gynecology Group
- Investigators
- Mohamed E Anter, MD, Principal investigator, Menoufia University hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04538391
- Sponsor's protocol ID
- 12/2019OBSGN38
- Status last verified
- Aug 2020
- First submitted
- 24 Aug 2020
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: through the E-maill address
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Versus Meloxicam Infiltration on Post Cesarean Section Pain Relief
- ClinicalTrials.gov ID
- NCT04538391
- Acronym / sponsor ID
- 12/2019OBSGN38
- Conditions
- Cesarean Section Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 3 Mar 2019 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 9 May 2020 (actual)
- First posted
- 4 Sep 2020 (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.
Investigation: compare the effect of local infiltration of incision site with bupivacaine and local infiltration with meloxicam in women undergoing cesarean sections on postoperative pain relief and analgesic requirement.
Condition: post cesarean sections analgesia intervention: infiltration of incision bupivacaine versus meloxicam Phase: Not applicable
Detailed description
study type: randomized clinical trial actual enrollment: 119 allocation: Random intervention model: three groups assignment masking: open lebal primary purpose: pain relief after Cesarean section actual study start: March 3, 2019 Primary Completion: March 5, 2020 actual study completion date: May 9, 2020
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Group A (bupivacaine group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. Group B (meloxicam group): included 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. Group C (placebo group): included 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline.
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Active comparator | Drug: local ifiltration Bupivacaine, Meloxican and placeboincluded 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with 20 ml of 0.25% bupivacaine hydrochloride. (Marcaine, 25% vial, Astra Zeneca) diluted in 20 ml of 0.9% saline. |
| meloxicam group | Active comparator | Drug: local ifiltration Bupivacaine, Meloxican and placeboincluded 35 patients in which and subcutaneous tissue (upper and lower flaps) were infiltrated with meloxicam 15mg (Anticox 2 ampoule 15mg/3ml, ADWIA Pharmaceuticals). diluted in 20 ml of 0.9% saline. |
| placebo group | Active comparator | Drug: local ifiltration Bupivacaine, Meloxican and placeboincluded 35 patients in which skin and subcutaneous tissue was infiltrated with 20 ml 0.9% saline. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 21-40 years
- Elective C.S at term
- Patient having no medical disorders
- Patient with no obstetrical complications
Key exclusion criteria (4 listed)
- extreme of reproductive age
- allergy to local anesthetic infiltration agent
- any medical disorders or obstetrical complications as ante partum hemorrhag, pre-eclampsia
- refusal to participate in the trial.
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 |
|---|---|---|
| local ifiltration Bupivacaine, Meloxican and placebono other intervention done | Drug | bupivacaine group, meloxicam group, placebo group |
Primary outcome
Postoperative pain scores
Time frame: immediately after the intervention
Assessment of pain scores after Cesarean section
Postoperative analgesic requirements
Time frame: immediately after the intervention
Assessment of Postoperative analgesic requirements
time of first dose of analgesia
Time frame: immediately after the intervention
Determination of time of first dose of analgesia
4 secondary outcomes
Postoperative fever
Time frame: immediately after the intervention
onset of mobilization
Time frame: immediately after the intervention
side effects of medications
Time frame: immediately after the intervention
Pain assessment by visual analogue scale
Time frame: immediately after the intervention
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 4 Sep 2020.
- Individual participant dataSharing planned: No. through the E-maill address
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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.
Mohamed E Anter, MD principal investigator
Menoufia University hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cesarean Section Pain, run by Menoufia University at 1 site in Egypt.
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 4 inclusion and 4 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 4 Sep 2020. 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 Egypt. 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 scores (time frame: immediately after the intervention). The study lists 3 primary outcomes in all. 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 4 Sep 2020.