A Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

Not Applicable

• Conditions: Post Operative Pain
• Interventions: Drug: normal saline 0.9%; Drug: Bupivacaine

• Registration Number: NCT03067168
• Lead Sponsor: The Christ Hospital

Brief Summary

To determine if levator muscle block with bupivacaine improves postoperative pain control relative to placebo controls among women undergoing prolapse surgery involving a posterior colporrhaphy. Improvement is defined as no less than a 25% lower total pain score on a ten point numerical pain scale.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-02-24
• Study First Posted: 2017-03-01
• Study Start: 2017-05-15
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-07
• Primary Completion: 2019-06-01
• Study Completion: 2019-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

• Any woman over the age of 18 years with a capacity to give informed consent who are undergoing vaginal prolapse surgery including a posterior colporrhaphy may be included in the study.

Exclusion Criteria

• Any woman who is a non-English speaker, does not have ability to provide consent, has a cardiac arrhythmia, liver disease, myasthenia gravis, bleeding diathesis or adverse reaction / allergy to anesthetic will be excluded. Women that are also having vaginal mesh excisions at the time of prolapse repair or those that will undergo subsequent surgery in the follow up period will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Arm	normal saline 0.9%	The subjects of this arm will receive an injection of 5mL of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 0.9% normal saline, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalic from first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.
Bupivacaine Arm	Bupivacaine	The subjects of this arm will receive an injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium into the levator ani muscle, puborectalis. A second injection of 5mL of 0.5% bupivacaine, 1-2 cm deep to the surface of the vaginal epithelium will be repeated on the same side, approximately 2-3 cm cephalad of the first injection at the iliococcygeus muscle. These 2 injections will then be repeated on the contralateral side.

Primary Outcome Measures

Name	Time	Method
Number of patients with improvement in pain, scored on a 10 point numerical pain scale.	1 year	Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.

Secondary Outcome Measures

Name	Time	Method
Postoperative care satisfaction scores, graded with a post-operative survey.	1 year	Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo.
Measure of morphine equivalents used in patients postoperatively.	1 year	A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts.
Length of hospital stay measured in hours.	1 year	Length, in hours, of hospital stay between study cohorts.

Trial Locations

Locations (3)

The Christ Hospital; 🇺🇸 Cincinnati, Ohio, United States

The University of Toledo; 🇺🇸 Toledo, Ohio, United States

The University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States