PainNCT00505362
Pain Study of Rectus Muscle Closure at Cesarean Delivery
A study testing Rectus closure in people with Pain, run by Stanford University at 1 site in United States.
Trial summary
Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- What is being tested?
- Rectus closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 37 weeks gestation Primary cesarean American Society of Anesthesiologists (ASA) class 1 or class 2
Who cannot join
- Chronic analgesia use Vertical skin incision at cesarean Opioid or Non-steroidal anti-inflammatory drugs (NSAID) allergy BMI >40 Labor
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: Rectus Muscle Closure vs. Non-Closure at Primary Cesarean Delivery and Post-Operative Pain
Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute these claims. The purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery.
Read the detailed description
There are more than 1 million cesarean deliveries performed annually in the United States, at a rate of 30.2% of all deliveries. Data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean. Adhesions are implicated in pelvic pain, infertility, difficult repeat surgery, and bowel obstruction. Practice techniques regarding rectus muscle reapproximation vary widely, and there are no data regarding the impact of this step on pain, and some data suggesting a reduction in significant adhesions. Given the frequency of cesarean deliveries, small changes in surgical technique may yield significant benefits.
We hope to learn 1) whether suture reapproximation of the rectus muscles increases pain, and 2) the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective, randomized trial.
All patients undergoing primary cesarean delivery at Lucile Packard Childrens Hospital (LPCH) will be offered the study. Once consented, patients will be randomized to one of two standardized closure techniques at cesarean: two-layer uterine closure, peritoneal closure, fascial and skin closure, and either reapproximation of the rectus muscles with three-interrupted sutures, or non-closure. Intra-operative and post-operative pain management will be standardized. Subjects will undergo pain assessments while in-house on post-operative days 1 and 3, and at the standard post-partum clinic visit after 6 weeks. These assessments will require less than 5 minutes of the patient's time. Patients will be shown a pain chart, and will be asked to rate their pain on a scale of 0 to 10 at rest. They will then stand up and rate their pain again. Pain medication usage will also be assessed.
The surgeons will know the groups to which the patients are randomized. The patients and those collecting data on pain scores will not.
Primary Endpoint: combined opioid use and movement pain score (Silverman Integrated Assessment-SIA) 72 post-operative hours.
Secondary Endpoint: surgical complications, maternal satisfaction with analgesia.
- Conditions
- Pain
- Being tested
- Rectus closure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus closureProcedure or surgery
Reapproximation of the rectus muscles with three-interrupted sutures
| Study group | Role | What they receive |
|---|---|---|
| Rectus muscle closure | Active comparator | Two-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. Receives: Procedure: Rectus closure |
| Rectus muscle non-closure | No intervention | Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain
Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.
Measured: 72-hour study period
Secondary outcomes (1)
Operative Times
Operative time of the cesarean delivery in minutes.
Measured: From start to the end of the cesarean delivery, assessed up to two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2007 (estimated)
- Study startJun 2006
- Primary completionAug 2014
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deirdre Judith Lyell, Stanford University
- Investigators
- Deirdre Judith Lyell, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00505362
- Sponsor's protocol ID
- 6107
- Status last verified
- Oct 2017
- First submitted
- 19 Jul 2007
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectus Muscle Closure vs. Non-Closure at Primary Cesarean Delivery and Post-Operative Pain
- ClinicalTrials.gov ID
- NCT00505362
- Acronym / sponsor ID
- 6107
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Aug 2014 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 23 Jul 2007 (estimated)
- Results
- Posted 27 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Suture reapproximation of the rectus muscles at primary cesarean delivery is a common practice about which there are no data. Some Obstetricians believe that suture reapproximation of the rectus muscles increases post-operative pain, and it may decrease adhesions, yet there are no published data to support or refute these claims. The purpose of this study is to assess the effect of rectus muscle reapproximation at cesarean delivery and post-operative pain. We also plan to assess the impact of rectus muscle closure on adhesions as seen at repeat cesarean delivery.
Detailed description
There are more than 1 million cesarean deliveries performed annually in the United States, at a rate of 30.2% of all deliveries. Data are limited regarding optimal surgical closure techniques to minimize adhesions at cesarean. Adhesions are implicated in pelvic pain, infertility, difficult repeat surgery, and bowel obstruction. Practice techniques regarding rectus muscle reapproximation vary widely, and there are no data regarding the impact of this step on pain, and some data suggesting a reduction in significant adhesions. Given the frequency of cesarean deliveries, small changes in surgical technique may yield significant benefits.
We hope to learn 1) whether suture reapproximation of the rectus muscles increases pain, and 2) the degree to which suture reapproximation of the rectus muscles alters adhesions when studied in a prospective, randomized trial.
All patients undergoing primary cesarean delivery at Lucile Packard Childrens Hospital (LPCH) will be offered the study. Once consented, patients will be randomized to one of two standardized closure techniques at cesarean: two-layer uterine closure, peritoneal closure, fascial and skin closure, and either reapproximation of the rectus muscles with three-interrupted sutures, or non-closure. Intra-operative and post-operative pain management will be standardized. Subjects will undergo pain assessments while in-house on post-operative days 1 and 3, and at the standard post-partum clinic visit after 6 weeks. These assessments will require less than 5 minutes of the patient's time. Patients will be shown a pain chart, and will be asked to rate their pain on a scale of 0 to 10 at rest. They will then stand up and rate their pain again. Pain medication usage will also be assessed.
The surgeons will know the groups to which the patients are randomized. The patients and those collecting data on pain scores will not.
Primary Endpoint: combined opioid use and movement pain score (Silverman Integrated Assessment-SIA) 72 post-operative hours.
Secondary Endpoint: surgical complications, maternal satisfaction with analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus muscle closure | Active comparator | Procedure: Rectus closureTwo-layer uterine closure, peritoneal closure, fascial and skin closure and reapproximation of the rectus muscles with three-interrupted sutures. |
| Rectus muscle non-closure | No intervention | –Two-layer uterine closure, peritoneal closure, fascial and skin closure, and rectus muscles non-closure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 37 weeks gestation Primary cesarean American Society of Anesthesiologists (ASA) class 1 or class 2
Key exclusion criteria (1 listed)
- Chronic analgesia use Vertical skin incision at cesarean Opioid or Non-steroidal anti-inflammatory drugs (NSAID) allergy BMI >40 Labor
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 closureReapproximation of the rectus muscles with three-interrupted sutures | Procedure or surgery | Rectus muscle closure |
Primary outcome
Post-operative Pain
Time frame: 72-hour study period
Post-operative pain was assessed using Silverman Integrated Assessment (SIA) pain score which combines the opioid use and movement pain score over the 72-hour study period. The SIA pain and opioid score is calculated by first rank ordering each patient's total opioid use (morphine milligram equivalents) and area under the curve (AUC) movement pain score over the 72 hour study period, then calculating a mean for both opioid use and movement pain scores, expressing both opioid use and movement pain score as percent differences from the mean, and lastly adding the percent differences from the mean for the two variables. The SIA composite score value for each subject ranges from approximately 200% to approximately -200%, with the highest positive score indicating the least comfortable or the most pain despite the greatest use of analgesics, and the lowest score indicating the most comfortable or least pain despite the least use of analgesics.
1 secondary outcome
Operative Times
Time frame: From start to the end of the cesarean delivery, assessed up to two hours.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Deirdre Judith Lyell principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus closure in people with Pain, run by Stanford University at 1 site in United States.
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 1 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 6 Nov 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 27 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-operative Pain (time frame: 72-hour study period). 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 6 Nov 2017.