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Pudendal Nerve Block for Postoperative Posterior Repair Pain Relief (PPPR)

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ClinicalTrials.gov Identifier: NCT02502591
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Royal Devon and Exeter NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Drug: Pudendal Nerve Block Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pudendal Nerve Block for Postoperative Pain Relief in Women Undergoing Posterior Vaginal Repairs: a Pilot Study
Study Start Date : August 2015
Actual Primary Completion Date : April 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention
Additional pain relief (a Pudendal Nerve Block (PNB)) will be administered during surgery in addition to routine care.
Drug: Pudendal Nerve Block
An injection of local anaesthetic (3 ml of 0.25% bupivacaine) will be administered around the trunk of the pudendal nerve.
Other Name: PNB

No Intervention: control
routine care only



Primary Outcome Measures :
  1. Post- op pain scores. as defined by VAS measure [ Time Frame: over a 48 hour post-operative period. ]
    Pain score defined by Visual Analogue Scores (VAS)



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02502591


Locations
United Kingdom
NIHR Exeter Clinical Research Facility
Exeter, Devon, United Kingdom, EX2 5DW
Sponsors and Collaborators
Royal Devon and Exeter NHS Foundation Trust
Investigators
Principal Investigator: Tracey Kay Royal Devon and Exeter NHS Foundation Trust

Responsible Party: Royal Devon and Exeter NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02502591     History of Changes
Other Study ID Numbers: 1510152
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical