Postoperative PainNCT04108975
Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain
A study testing Rectus muscle reapproximation during CS and Rectus muscle non reapproximation during CS in people with Postoperative Pain, run by Assiut University.
Trial summary
The aim of this study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Rectus muscle reapproximation during CS and Rectus muscle non reapproximation during CS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Oct 2022
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Primigravida
- Single pregnancy
- Term at >37 weeks
- Maternal age between 18 and 35 yrs
- Spinal anaesthesia.
- No other medical diseases.
Who cannot join
- • prior laparotomy
- vertical skin incision
- chronic analgesia use
- allergy to opioid or nonsteroidal anti-inflammatory drugs
- body mass index more than or equal to 40.
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.
Read the detailed description
In recent years, Cesarean deliveries have increased dramatically worldwide. In Egypt, 52% of women give birth by Cesarean Section according to the 2014 Demographic and Health survey. Despite the rising incidence of Cesarean section, controversy about the optimal surgical method of Cesarean section still remains. Obstetricians use a variety of surgical techniques to reduce post-operative adhesions after Cesarean section, such as parietal peritoneal closure and rectal muscle approximation. They believe that adhesions may result from exposure of an opened intraperitoneal cavity to the subfascial space which can be prevented by approximating the rectus muscle or closing the parietal peritoneum. In addition, rectus muscle approximation may be considered to reduce the risk of persistent rectus muscle diastasis. However, different studies showed a controversy and inconsistency in the practice of rectus muscle re-approximation among surgeons. Some obstetricians agree that the rectus muscles can regain their right anatomic position by themselves and that suturing them together does not add any benefit. Even though, one of their main concern against rectus muscle approximation is its potential association with increased post operative pain, hence the importance of this prospective randomized controlled study. The aim of the investigator's study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.
- Conditions
- Postoperative Pain
- Being tested
- Rectus muscle reapproximation during CS, Rectus muscle non reapproximation during CS
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus muscle reapproximation during CSProcedure or surgery
Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.
Rectus muscle non reapproximation during CSProcedure or surgery
During CS rectus muscle non reapproximation will be done.
| Study group | Role | What they receive |
|---|---|---|
| Rectus muscle reapproximation group | Active comparator | Rectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures Receives: Procedure: Rectus muscle reapproximation during CS |
| Rectus muscle non reapproximation group | Active comparator | No rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position Receives: Procedure: Rectus muscle non reapproximation during CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain: 4 point verbal rating scale (VRS)
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale.
Measured: 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start1 Oct 2019 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelraheem Ali, Assiut University
- Investigators
- Ahmed Aboalfadl, Professor, Study director, Assiut UniversityDiaa Abdelaal, Professor, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04108975
- Sponsor's protocol ID
- Rectus muscle reapproximation
- Status last verified
- Sep 2019
- First submitted
- 26 Sep 2019
- Last updated
- 30 Sep 2019
- Results posted
- 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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Effect of Rectus Muscle Reapproximation Versus Non Reapproximation During CS on Postoperative Pain
- ClinicalTrials.gov ID
- NCT04108975
- Acronym / sponsor ID
- Rectus muscle reapproximation
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 30 Sep 2019 (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.
The aim of this study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.
Detailed description
In recent years, Cesarean deliveries have increased dramatically worldwide. In Egypt, 52% of women give birth by Cesarean Section according to the 2014 Demographic and Health survey. Despite the rising incidence of Cesarean section, controversy about the optimal surgical method of Cesarean section still remains. Obstetricians use a variety of surgical techniques to reduce post-operative adhesions after Cesarean section, such as parietal peritoneal closure and rectal muscle approximation. They believe that adhesions may result from exposure of an opened intraperitoneal cavity to the subfascial space which can be prevented by approximating the rectus muscle or closing the parietal peritoneum. In addition, rectus muscle approximation may be considered to reduce the risk of persistent rectus muscle diastasis. However, different studies showed a controversy and inconsistency in the practice of rectus muscle re-approximation among surgeons. Some obstetricians agree that the rectus muscles can regain their right anatomic position by themselves and that suturing them together does not add any benefit. Even though, one of their main concern against rectus muscle approximation is its potential association with increased post operative pain, hence the importance of this prospective randomized controlled study. The aim of the investigator's study is to assess the effect of rectus muscle re-approximation by 3 interrupted simple sutures versus tighting it by 3 vertical mattress sutures during cesarean delivery on postoperative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus muscle reapproximation group | Active comparator | Procedure: Rectus muscle reapproximation during CSRectus muscle reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures |
| Rectus muscle non reapproximation group | Active comparator | Procedure: Rectus muscle non reapproximation during CSNo rectus muscle reapproximation will be done based on the fact that rectus muscle can regain its position |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- • Primigravida
Key exclusion criteria (5 listed)
- • prior laparotomy
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 |
|---|---|---|
| Rectus muscle reapproximation during CSReapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures. | Procedure or surgery | Rectus muscle reapproximation group |
| Rectus muscle non reapproximation during CSDuring CS rectus muscle non reapproximation will be done. | Procedure or surgery | Rectus muscle non reapproximation group |
Primary outcome
Postoperative pain: 4 point verbal rating scale (VRS)
Time frame: 1 week after operation
Post-operative pain is analyzed by using 4 point verbal rating scale (VRS) which consists of a list of adjectives describing different levels of pain intensity i.e (no pain =1, mild pain = 2, moderate pain = 3, severe pain = 4), patients are asked to read this list of adjectives and select the word that best describes their level of pain on the scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Ahmed Aboalfadl, Professor study director
Assiut University
Diaa Abdelaal, Professor study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Rectus muscle reapproximation during CS and Rectus muscle non reapproximation during CS in people with Postoperative Pain, run by Assiut University.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abdelraheem Ahmed, Dr (+201090435363, abdelrahim_muhammed2017@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain: 4 point verbal rating scale (VRS) (time frame: 1 week after operation). 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 30 Sep 2019.