Postoperative PainNCT02679365
Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
A study testing lower segment cesarean section and double lock closure of rectus sheath and lower segment cesarean section and continuous non-locking closure of rectus sheath in people with Postoperative Pain, run by Ain Shams Maternity Hospital.
Trial summary
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- lower segment cesarean section and double lock closure of rectus sheath and lower segment cesarean section and continuous non-locking closure of rectus sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jul 2017
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- first cesarean section
Who cannot join
- urgent cesarean section
- previous abdominal surgery
- previous cesarean section
- obstetric and medical complications
About this study
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.
- Conditions
- Postoperative Pain
- Being tested
- lower segment cesarean section and double lock closure of rectus sheath, lower segment cesarean section and continuous non-locking closure of rectus sheath
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lower segment cesarean section and double lock closure of rectus sheathProcedure or surgery
lower segment cesarean section and continuous non-locking closure of rectus sheathProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| group a | Experimental | This arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath. Receives: Procedure: lower segment cesarean section and double lock closure of rectus sheath |
| group b | Active comparator | This arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath. Receives: Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain evaluated by VAS
Measured: first week postoperative
Secondary outcomes (1)
operative time
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
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.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr mohammed elsafty, Ain Shams Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02679365
- Sponsor's protocol ID
- 2476ASU
- Status last verified
- Jul 2017
- First submitted
- 7 Feb 2016
- Last updated
- 1 Aug 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Lock Versus Continuous Non-locking Technique for Closure of Rectus Sheath in Cesarean Sections on Post-operative Pain
- ClinicalTrials.gov ID
- NCT02679365
- Acronym / sponsor ID
- 2476ASU
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 10 Feb 2016 (estimated)
- 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.
In this trial we compare the effect of 2 closure techniques of the rectus sheath during cesarean sections on postoperative pain. One closure technique is double lock technique and the other is the conventional continuous non-locking technique.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group a | Experimental | Procedure: lower segment cesarean section and double lock closure of rectus sheathThis arm will have lower segment cesarean section done with double locking technique for closure of Rectus Sheath. |
| group b | Active comparator | Procedure: lower segment cesarean section and continuous non-locking closure of rectus sheathThis arm will have lower segment cesarean section done with continuous non-locking technique for closure of rectus sheath. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- first cesarean section
Key exclusion criteria (4 listed)
- urgent cesarean section
- previous abdominal surgery
- previous cesarean section
- obstetric and medical complications
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 |
|---|---|---|
| lower segment cesarean section and double lock closure of rectus sheath | Procedure or surgery | group a |
| lower segment cesarean section and continuous non-locking closure of rectus sheath | Procedure or surgery | group b |
Primary outcome
postoperative pain evaluated by VAS
Time frame: first week postoperative
1 secondary outcome
operative time
Time frame: intraoperative
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 1 Aug 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing lower segment cesarean section and double lock closure of rectus sheath and lower segment cesarean section and continuous non-locking closure of rectus sheath in people with Postoperative Pain, run by Ain Shams Maternity Hospital.
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 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 1 Aug 2017. 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?
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 evaluated by VAS (time frame: first week postoperative). 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 1 Aug 2017.