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

NCT03067168 | Unknown DMC

• 1 other identifier: TCH# 15-02
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 3

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.

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Postoperative care satisfaction scores, graded with a post-operative survey.

  1 year

• Measure of morphine equivalents used in patients postoperatively.

  1 year

• Length of hospital stay measured in hours.

  1 year

Study Arms (2)

Bupivacaine Arm

ACTIVE COMPARATOR

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.

Drug: Bupivacaine

Placebo Arm

PLACEBO COMPARATOR

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.

Drug: normal saline 0.9%

Interventions

Bupivacaine DRUG

5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.

Also known as: Marcaine

Bupivacaine Arm

normal saline 0.9% DRUG

5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.

Also known as: Saline

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Patients that are eligible would be undergoing vaginal prolapse surgery including posterior colporrhaphy, therefore would need to have a vagina to be enrolled in this study
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Christ Hospital: lead
• University of Kansas Medical Center: collaborator

Study Sites (3)

The University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The University of Toledo

Toledo, Ohio, 43606, United States

Location

Related Publications (1)

• Kaeser CT, Rothenberger R, Zoorob D, Whiteside JL. Bupivacaine Use After Posterior Colporrhaphy to Reduce Postoperative Pain: A Multicenter, Double-Blinded, Placebo-Controlled, Randomized Clinical Trial. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):72-76. doi: 10.1097/SPV.0000000000001082.

  PMID: 34171880 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Carson T Kaeser, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects will not know if they received an injection of bupivacaine or placebo, i.e., normal saline after completion of surgery. The surgeon, as well as any investigator or study personnel, will be blinded to injection type.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Female Pelvic Medicine and Reconstructive Surgery

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: March 1, 2017
• Study Start: May 15, 2017
• Primary Completion: June 1, 2019
• Study Completion: August 1, 2019
• Last Updated: January 7, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)