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

Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension: The PAIN-S Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Pudendal nerve block; Drug: Bupivacaine Injectable Product; Procedure: Sham Pudendal nerve block

Detailed Description

Study Procedures:

Randomization and Blinding:

Women will be randomized to receive either Bupivacaine 0.25% or Normal Saline pudendal injections based on the label within a sealed envelope randomly selected on the day of their surgery. Fifty labels will be created with twenty-five labels each of "Bupivacaine 20ml" or "Normal Saline 20ml" written on them. These will be placed in blank, identical envelopes and sealed and shuffled prior to the start of the study. Upon selection, the sealed envelope will be given to the circulating nurse who will draw up the selected solution and label it "pudendal block". The circulating nurse will be directed to not disclose the contents of the envelope or syringe to the participant or to any other member of the team. They will then re-seal the envelope with tape, place a patient label on it and return it to the surgical team post procedure to be returned to a locked file cabinet within the surgical office at the end of the day, to be kept securely with medical records. Group allocation envelopes will be opened after the collection of all outcome data is complete to allow for data analysis. In order to avoid local anesthetic toxicity, any calculations for other anesthetic agents utilized for the surgical procedure or anesthetic will assume that 20 ml of 0.25% Bupivacaine was administered. In the event that an emergent adverse complication is identified which may be attributable to the administered agent, the treatment allocation can be unblinded if this is deemed clinically necessary by the investigator or other treating physician. In the event this is required, the patient will be withdrawn from the study and excluded from the final analysis, but such case(s) will be described in the final study results.

The circulating nurse already draws up local anesthetic and normal saline as a routine part of this procedure for use in other ways, and so the investigators do not anticipate that their participation in this study will be a large burden of work. The investigators estimate that it will add no more than 2 minutes to their preparation time for the surgery.

Pudendal Block administration:

The Pudendal block will be administered by the Surgeon or Surgical Fellow after the administration of anesthetic and preparation for surgery but before the first surgical incision. It will be administered with standard transvaginal technique.

Standardization of the Anesthesia, Pre-op and postoperative pain management:

Pre-operative, postoperative and intra-operative care will be standardized according to guidelines that meet criteria for current standard of care as outlined in the appendix. These pages will be printed on the chart to identify the patient as a participant in the study and also to remind the surgical and anesthetic team of the guidelines of the study.

Standardization of postoperative pain management after discharge:

All patients will receive the same instructions for management of postoperative pain. They will receive instructions to use acetaminophen (Tylenol) regularly as well as Ibuprofen (Advil) regularly as long as they have no contraindications or allergies to these medications. They will be given a standardized prescription for tramadol to use in addition to these medications for management of breakthrough pain.

Study and Follow up Visits:

The patient will have no additional visits attributed to their participation in this study. Instead they will receive electronic (email or text) surveys and telephone reminders over a period of 2 weeks after their operation. The first survey will take less than 1 minute to complete, the second will take less than 5 minutes to complete, and the final survey less than 10 minutes to complete.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sophia Badowski, MD; Phone Number: 6138889851; Email: slenson@qmed.ca
• Study Contact Backup: Name: Darren Lazare, MD; Phone Number: 6047279000; Email: darren.Lazare@fraserhealth.ca

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3V 0C6
      • Recruiting
      • City Centre Obstetrics and Gynecology
      • Contact: Sophia Badowski; Phone Number: 6138889851; Email: slenson@qmed.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Those with an allergy to local anesthetic (freezing injections)
• Those who prefer to have surgery under spinal anesthesia
• Those with planned concurrent vulvar, laparoscopic or abdominal surgery, or any planned concurrent vaginal surgery other than those in the inclusion criteria.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pudendal nerve block; 25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions.	Procedure: Pudendal nerve block; Vaginally administered pudendal nerve block of 10ml 0.25% Bupivacaine prior to making any surgical incisions.; Drug: Bupivacaine Injectable Product; Used for pudendal nerve block in the intervention arm
Sham Comparator: Placebo; 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; Vaginally administered pudendal nerve block of 10ml Normal Saline prior to making any surgical incisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readiness for discharge	measured on a 5 point Likert scale	measured at post-operative day 0 prior to discharge
Patient satisfaction	measured on a 5 point Likert scale	measured at postoperative day 0
Patient satisfaction	measured on a 5 point Likert scale	measured at postoperative day 1
Patient satisfaction	measured on a 5 point Likert scale	measured at postoperative day 14
Functional Recovery Index	Validated tool by Wong et al. Involving measures of return to activities of daily living	measured at postoperative day 1
Functional Recovery Index	Validated tool by Wong et al. Involving measures of return to activities of daily living	measured at postoperative day 14
Post-operative Analgesic use	pill count	measured at postoperative day 14

Collaborators and Investigators

• Sponsor: Fraser Health

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 25, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): February 2, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: FHREB2020-143

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No