Complications; Cesarean Section, Pregnancy
Conditions
Keywords
Postpartum pain, Post-cesarean pain, Surgical retractor, Elastic retractor
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.
Interventions
DEVICEMobius 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.
Sponsors
Apple Medical Corporation
Abbey Hardy-Fairbanks
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
July 2008 to March 2010
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| 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. | 78 |
| Total | 154 |
Baseline characteristics
| Characteristic | Mobius | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 78 Participants | 76 Participants | 154 Participants |
| Age, Continuous | 30.3 years STANDARD_DEVIATION 5.3 | 31.1 years STANDARD_DEVIATION 5.7 | 30.7 years STANDARD_DEVIATION 5.5 |
| Region of Enrollment United States | 78 participants | 76 participants | 154 participants |
| Sex: Female, Male Female | 78 Participants | 76 Participants | 154 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 76 | 0 / 78 |
| serious Total, serious adverse events | 0 / 76 | 0 / 78 |
Outcome results
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.
Time frame: 2 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control | The Degree of Pain With Activity on Post-operative Day Number Two | 6.4 cm | Standard Deviation 3 |
| Mobius | The Degree of Pain With Activity on Post-operative Day Number Two | 6.3 cm | Standard Deviation 2.9 |
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.
Time frame: 2 days post-operation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery | 33 participants |
| Mobius | Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery | 32 participants |