Pudendal Nerve Block for Postoperative Posterior Repair Pain Relief

NCT02502591 | Completed Phase 2

• 1 other identifier: 1510152
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Rectocoele or a posterior vaginal prolapse (bulge in the vagina) is a frequent gynaecological condition. It is repaired by repairing and reinforcing the support to the vaginal wall at the back. A small cut is made through the lining of the back wall of the vagina. The supports to the rectum are reinforced with stitches and the bulging part of the vaginal wall cut away. The wound in the vagina is then stitched up. Rectocoele repair is usually carried under a general anaesthetic with women reporting moderate to severe degrees of pain post operatively on sitting down. A Pudendal Nerve Block (PNB) is a common analgesic (pain killing) technique often used for women who need an instrumental delivery during childbirth. It is also widely used during a range of surgical procedures (operations) as a preventive analgesia to help reducing post -operative pain. The investigators would like to see if using this technique during routine rectocele repair will help with post - op pain.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Post- op pain scores. as defined by VAS measure

  Pain score defined by Visual Analogue Scores (VAS)

  over a 48 hour post-operative period.

Study Arms (2)

intervention

EXPERIMENTAL

Additional pain relief (a Pudendal Nerve Block (PNB)) will be administered during surgery in addition to routine care.

Drug: Pudendal Nerve Block

control

NO INTERVENTION

routine care only

Interventions

Pudendal Nerve Block DRUG

An injection of local anaesthetic (3 ml of 0.25% bupivacaine) will be administered around the trunk of the pudendal nerve.

Also known as: PNB

intervention

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing isolated posterior vaginal wall repair under GA
• Age 20-80 yrs
• Wiling and able to provide informed consent

You may not qualify if:

• Women undergoing concomitant anterior repairs, vaginal hysterectomies or mesh repair
• History of chronic pelvic pain.
• Known allergy to local anaesthetic agents
• Unable/unwilling to provided informed consent

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

NIHR Exeter Clinical Research Facility

Exeter, Devon, EX2 5DW, United Kingdom

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Tracey Kay

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 20, 2015
• Study Start: August 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 11, 2018

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)