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

Post Operative Pain Clinical Trial

Official title:

A Multicenter, Double Blinded, Randomized Controlled Trial of Levator Muscle Blocks Following Posterior Colporrhaphy Surgery to Reduce Post-operative Pain.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03067168
• Other study ID #: TCH# 15-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 15, 2017
• Est. completion date: August 1, 2019

Study information

• Verified date: January 2019
• Source: The Christ Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 128
• Est. completion date: August 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Bupivacaine
5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.
• normal saline 0.9%
5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.

Locations

Country	Name	City	State
United States	The Christ Hospital	Cincinnati	Ohio
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	The University of Toledo	Toledo	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Christ Hospital	The University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with improvement in pain, scored on a 10 point numerical pain scale.	Improvement is defined as a 25% or lower total pain score on a ten point numerical pain scale compared to placebo.	1 year
Secondary	Postoperative care satisfaction scores, graded with a post-operative survey.	Improvement in satisfaction is defined as an overall satisfaction score of 20% or more on the post-operative survey compared to placebo.	1 year
Secondary	Measure of morphine equivalents used in patients postoperatively.	A reduction in opiate use is defined as a 20% reduction in total number of morphine equivalents used between study cohorts.	1 year
Secondary	Length of hospital stay measured in hours.	Length, in hours, of hospital stay between study cohorts.	1 year