Mobius® Post-cesarean Pain Randomized Control Trial

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685932
• Other study ID #: 21107
• Status: Completed
• Phase: N/A
• First received: May 26, 2008
• Last updated: March 19, 2018
• Start date: July 2008
• Est. completion date: June 2010

Study information

• Verified date: March 2018
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Abbey Hardy-Fairbanks	Apple Medical Corporation

Country where clinical trial is conducted

United States, 

References & Publications (11)

Chanrachakul B, Hamontri S, Herabutya Y. A randomized comparison of postcesarean pain between closure and nonclosure of peritoneum. Eur J Obstet Gynecol Reprod Biol. 2002 Feb 10;101(1):31-5. — View Citation

Dodd J, Pearce E, Crowther C. Women's experiences and preferences following Caesarean birth. Aust N Z J Obstet Gynaecol. 2004 Dec;44(6):521-4. — View Citation

Dunn EA, O'Herlihy C. Comparison of maternal satisfaction following vaginal delivery after caesarean section and caesarean section after previous vaginal delivery. Eur J Obstet Gynecol Reprod Biol. 2005 Jul 1;121(1):56-60. — View Citation

Giacalone PL, Daures JP, Vignal J, Herisson C, Hedon B, Laffargue F. Pfannenstiel versus Maylard incision for cesarean delivery: A randomized controlled trial. Obstet Gynecol. 2002 May;99(5 Pt 1):745-50. — View Citation

Granot M, Lowenstein L, Yarnitsky D, Tamir A, Zimmer EZ. Postcesarean section pain prediction by preoperative experimental pain assessment. Anesthesiology. 2003 Jun;98(6):1422-6. — View Citation

Kadir RA, Khan A, Wilcock F, Chapman L. Is inferior dissection of the rectus sheath necessary during Pfannenstiel incision for lower segment Caesarean section? A randomised controlled trial. Eur J Obstet Gynecol Reprod Biol. 2006 Sep-Oct;128(1-2):262-6. Epub 2006 Apr 18. — View Citation

McCarthy M Jr, Chang CH, Pickard AS, Giobbie-Hurder A, Price DD, Jonasson O, Gibbs J, Fitzgibbons R, Neumayer L. Visual analog scales for assessing surgical pain. J Am Coll Surg. 2005 Aug;201(2):245-52. Erratum in: J Am Coll Surg. 2005 Nov;201(5):826. — View Citation

Nafisi S. Influence of uterine exteriorization versus in situ repair on post-Cesarean maternal pain: a randomized trial. Int J Obstet Anesth. 2007 Apr;16(2):135-8. Epub 2007 Feb 5. — View Citation

Pan PH, Coghill R, Houle TT, Seid MH, Lindel WM, Parker RL, Washburn SA, Harris L, Eisenach JC. Multifactorial preoperative predictors for postcesarean section pain and analgesic requirement. Anesthesiology. 2006 Mar;104(3):417-25. — View Citation

Rafique Z, Shibli KU, Russell IF, Lindow SW. A randomised controlled trial of the closure or non-closure of peritoneum at caesarean section: effect on post-operative pain. BJOG. 2002 Jun;109(6):694-8. — View Citation

Thompson JF, Roberts CL, Currie M, Ellwood DA. Prevalence and persistence of health problems after childbirth: associations with parity and method of birth. Birth. 2002 Jun;29(2):83-94. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Degree of Pain With Activity on Post-operative Day Number Two	Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.	2 days
Secondary	Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery	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.	2 days post-operation

External Links

•   Dartmouth-Hitchcock Medical Center home page
•   Description of Mobius retractor from the manufacturer