Mobius® Post-cesarean Pain Randomized Control Trial

Not Applicable

Completed

Conditions: Complications; Cesarean Section
Pregnancy

Interventions: Device: Mobius Retractor

Registration Number: NCT00685932

Lead Sponsor: Abbey Hardy-Fairbanks

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 154

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mobius	Mobius Retractor	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.

Primary Outcome Measures

Name	Time	Method
The Degree of Pain With Activity on Post-operative Day Number Two	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 Outcome Measures

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