Mobius® Post-cesarean Pain Randomized Control Trial
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/14/2017 |
| Start Date: | July 2008 |
| End Date: | June 2010 |
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.
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.
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.
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
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