Pudendal Nerve Block for Postoperative Posterior Repair Pain Relief (PPPR)
|ClinicalTrials.gov Identifier: NCT02502591|
Recruitment Status : Completed
First Posted : July 20, 2015
Last Update Posted : April 11, 2018
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
- 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)
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
|NIHR Exeter Clinical Research Facility|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Principal Investigator:||Tracey Kay||Royal Devon and Exeter NHS Foundation Trust|