Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension

NCT04733560 | Unknown

• 1 other identifier: FHREB2020-143
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pelvic organ prolapse is a common problem. It affects about half of women and causes uncomfortable bulge sensations (similar to sitting on a ball), urine and stool problems, difficulty with sexual activity and embarrassment. Almost one of every five women undergoes surgery to treat prolapse.Typically, vaginal surgery is done while patients are asleep and local anesthetic- freezing medication- is injected where incisions are made to minimize the pain from surgery when waking up. Pudendal blocks are nerve blocks where local anesthetic is used to freeze a nerve that supplies sensation to the vulva and vaginal area. It is traditionally used to help with pain for women giving birth, but hasn't been studied well in women undergoing vaginal surgery for prolapse. The investigators believe that by using a small amount of freezing to provide a pudendal block at the time of surgery, on top of the freezing typically provided, that there will be minimized pain after surgery and improve the recovery process. Based on previous studies using pudendal blocks for different vulvar and vaginal procedures, the investigators believe this to be a safe and potentially beneficial practice. The investigators are planning to conduct a randomized controlled trial of 50 women. 25 will receive pudendal nerve blocks at the time of surgery, and 25 will receive placebo injections.The investigators will monitor their pain scores, satisfaction, use of pain medications and return to activities in order to determine if our intervention has caused a significant improvement in recovery.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (3)

• Post-operative Pain Score

  measured on a Visual Analog scale (1-10)

  measured at post-operative day 0

• Post-operative Pain Score

  measured on a Visual Analog scale (1-10)

  measured at post-operative day 1

• Post-operative Pain Score

  measured on a Visual Analog scale (1-10)

  measured at post-operative day 14

Secondary Outcomes (7)

• Readiness for discharge

  measured at post-operative day 0 prior to discharge

• Patient satisfaction

  measured at postoperative day 0

• Patient satisfaction

  measured at postoperative day 1

• Patient satisfaction

  measured at postoperative day 14

• Functional Recovery Index

  measured at postoperative day 1

Study Arms (2)

Pudendal nerve block

EXPERIMENTAL

25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions.

Procedure: Pudendal nerve block; Drug: Bupivacaine Injectable Product

Placebo

SHAM COMPARATOR

25 women will receive sham pudendal nerve blocks using normal saline. These will also be administed vaginally prior to making any surgical incisions.

Procedure: Sham Pudendal nerve block

Interventions

Pudendal nerve block PROCEDURE

Vaginally administered pudendal nerve block of 10ml 0.25% Bupivacaine prior to making any surgical incisions.

Pudendal nerve block

Sham Pudendal nerve block PROCEDURE

Vaginally administered pudendal nerve block of 10ml Normal Saline prior to making any surgical incisions.

Placebo

Bupivacaine Injectable Product DRUG

Used for pudendal nerve block in the intervention arm

Pudendal nerve block

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over 18 years of age
• Diagnosed with prolapse and planning to undergo vaginal day surgery as treatment.
• Must be undergoing a sacrospinous ligament fixation as part of their procedure. Those undergoing a concurrent anterior and/or posterior vaginal repair, or mid-urethral sling will also be included.
• Able to read and write in English
• Able to complete email surveys for the first 2 weeks after surgery

You may not qualify if:

• Those with an allergy to local anesthetic (freezing injections)
• Those who prefer to have surgery under spinal anesthesia
• Those with a pre-existing chronic pain disorder requiring the regular use of opioid analgesics (more than twice weekly)
• Those with a history of substance abuse
• Those with a history of bleeding disorder
• Those who would prefer not to participate in the study,
• If unable to receive emails in order to fill out the surveys.
• Inability to provide informed consent
• Currently enrolled in any other research study involving drugs or devices

Sponsors & Collaborators

• Fraser Health: lead

Study Sites (1)

City Centre Obstetrics and Gynecology

Surrey, British Columbia, V3V 0C6, Canada

RECRUITING

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sophia Badowski, MD

CONTACT

6138889851; slenson@qmed.ca

Darren Lazare, MD

CONTACT

6047279000; darren.Lazare@fraserhealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients are surgeons are blinded to the contents of the injections (either local anesthetic or saline). Allocations will be revealed after all data is collected at the time of data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: January 25, 2021
• First Posted: February 2, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

CA (1)