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Completed

NCT Number: NCT00685932

Mobius® Post-cesarean Pain Randomized Control Trial

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.

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Key information

Conditions

Complications; Cesarean Section Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobius Retractor

Device

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.

Primary outcomes

  1. The Degree of Pain With Activity on Post-operative Day Number Two

    Time frame: 2 days

    Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.

Secondary outcomes

  1. Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery

    Time frame: 2 days post-operation

    Visual analog scale will be used to assess pain on the right or left side of the body with activity.VAS will use a 0-7.5cm range on the right and 0-7.5cm range on the left. This scale is with 0 (or central mark) as no pain and increasing as the subject marks away from the central mark.

Sponsors and collaborators

Lead sponsor

Abbey Hardy-Fairbanks

Other

Collaborators

  • Apple Medical Corporation

Registry information

Official study title

Mobius Pain Study: A Randomized Controlled Trial of Standard Versus Mobius® Retraction at Cesarean Delivery

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 29, 2008
Registry last updated
Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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