Mobius® Post-cesarean Pain Randomized Control Trial

This study has been completed.
Sponsor:
Collaborator:
Apple Medical Corporation
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT00685932
First received: May 26, 2008
Last updated: October 19, 2011
Last verified: October 2011

May 26, 2008
October 19, 2011
July 2008
June 2010   (final data collection date for primary outcome measure)
Primary outcome measure if decreased overall post- cesarean section pain in the Mobius arm of the study. [ Time Frame: 3 days post-operatiion ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00685932 on ClinicalTrials.gov Archive Site
Secondarily we will examine if the Mobius retractor decreases asymmetrical pain which is significantly more common in cesarean section patients versus vaginal delivery patients. [ Time Frame: 3 days post-operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Mobius® Post-cesarean Pain Randomized Control Trial
Mobius Pain Study: A Randomized Controlled Trial of Standard Versus Mobius® Retraction at Cesarean Delivery

The purpose of this study is to investigate whether the use of the Mobius® retractor decreased post-operative pain after cesarean section verses conventional retractor use. Based on clinical experience and a pilot study, we suspect that the retractor will decrease overall pain as well as lateral pain.

This is a prospective, randomized, patient blinded trial of standard surgical retraction versus Mobius® retraction at cesarean delivery. Women will be approached by their provider at their 36 week prenatal visit regarding potential study participation. They will be given a letter describing the study. If a woman is interested, she will be contacted by a study nurse who will obtain informed consent. Ideally, women will be approached prior to the onset of labor or date of scheduled cesarean delivery so as to provide adequate time to review the study and ask questions. Women who undergo antenatal admission will be also approached by their provider regarding possible study participation and given a recruitment letter. If they are interested, then a study nurse will obtain informed consent.

Consenting women will be randomized after the decision to deliver by cesarean section is made. Randomization will be performed in blocks to control for scheduled versus unscheduled cesarean deliveries using a random numbers generator. Assignments will be kept in sequentially number opaque envelopes. Women will not be informed of their assignment until after discharge from the hospital. Efforts will be made in the operating room to avoid disclosing group assignment and the consent forms will not contain the specific name of the retractor under study. The operative team will be aware of group assignment.

Participants will complete a 7 item pain scale each post-operative day until discharge. This pain scale has been used in a pilot study and found to be accurate. The pain scale is a single page and takes less than 5 minutes to complete.

Charts will be reviewed to obtain clinical information which may have an impact on post-operative pain. This includes information about current and past substance abuse. Because of the increased amounts of post-operative pain experienced by women who use methadone during pregnancy, this group of women will be excluded from the study. To protect the information regarding substance abuse, a certificate of confidentiality has been obtained from the NIH.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Cesarean Section
  • Pregnancy
Device: Mobius Retractor
The Mobius retractor is a dual ring elastic self retaining retractor that is inserted into the abdominal cavity after the peritoneal incision has been established. It is then left in place during the hysterotomy incision, delivery of the fetus, hysterotomy repair, inspection and irrigation.
Other Name: Mobius Retractor
  • No Intervention: Control
    This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
  • Experimental: Mobius
    This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
    Intervention: Device: Mobius Retractor

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
125
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Over 18 years old
  • Potential for having a cesarean section (scheduled or unscheduled) at Dartmouth Hitchcock Medical Center

Exclusion Criteria:

  • Less than 18 years old
  • Unable to consent due to language barrier or psychiatric illness
  • Current methadone use for chronic pain
  • Stat cesarean section
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00685932
21107
Yes
Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
Apple Medical Corporation
Principal Investigator: Michele Lauria, MD, MS Dartmouth-Hitchcock Medical Center
Dartmouth-Hitchcock Medical Center
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP