Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02502591 |
| Other study ID # |
1510152 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
July 17, 2015 |
| Last updated |
April 10, 2018 |
| Start date |
August 2015 |
| Est. completion date |
August 2017 |
Study information
| Verified date |
May 2017 |
| Source |
Royal Devon and Exeter NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Pelvic Organ Prolapse (POP) can occur in up to 50% of women after childbirth. Common
complications include urinary infection, postoperative pain, and wound infection.
The majority of prolapse repair procedures are carried out under general anaesthetic (GA)
with regular analgesia required post operatively. The pain is often described as "agonizing"
and results in a substantial consumption of analgesia, often leading to extended periods of
bladder catheterisation and bowel dysfunction. Despite numerous attempts to modify surgical
techniques and anaesthetic regimens, the problems persist.
In an attempt to relieve the problem local clinicians have had promising results from the
addition of a standardised preventive Pudendal Nerve Block (PNB) in reducing post- op pain.
To widen the clinical utility of this procedure an evidence base will be required.
Preventive analgesia: Preventive analgesia is a broad term used to describe an analgesic
regime given during surgery to control post - op pain and its aim is to reduce the impact of
the process known as central sensitization. This refers to an increase in synaptic efficacy
in the somatosensory neurons following tissue injury (e.g. surgery) or nerve damage. This
leads to a reduction in pain threshold, an amplification of pain responses and a spread of
pain sensitivity to non-injured areas resulting in increased post -op pain intensity and
analgesic requirements. Preventive analgesics (including nerve blocks) have been incorporated
into a range of surgical procedures, with a recent review identifying its strong positive
impact on post-operative pain and analgesic consumption.
The Pudendal nerve is a mixed nerve (sensory and motor) derived from the somatic component of
sacral nerve roots S2-S4. It is located behind the sacrospinous ligament. It supplies anal
and urethral sphincters, the pelvic floor muscles, anal and perineal skin. PNB is a routine
procedure used during instrumental deliveries in obstetrics and as a low-risk, low-cost
anaesthetic technique effectively reducing perineal and vaginal discomfort during repair of
obstetric lacerations. PNB is also increasingly being utilised as a preventive analgesia with
positive results on pain relief, reduced analgesics, improved spontaneous micturition, less
pain on defecation and shorter hospital stay and pain on following haemorrhoidectomy.
Improving post- operative pain relief and enhancing patient recovery is of fundamental
importance to both the individual and the National Health Service (NHS). This study is a
preliminary step in the assessment of a preventive analgesia on women's post- op experience
following routine posterior vaginal wall surgery.
Hypothesis: The addition of a PN), administered during routine rectocele repair being carried
out under general anaesthetic (GA), will provide more effective and prolonged postoperative
analgesia and shorter hospital stay compared to receiving GA alone.
Aim: To obtain preliminary data on the impact of administering a standard PNB during routine
rectocele repair on women's post-op experience, and assess the feasibility of future studies
on the potential for the procedure to become a routine part of clinical practice.
Objectives are to assess: the feasibility of recruitment and retention, the impact of the PNB
on women's post-op experience, and obtain preliminary data to inform sample size calculations
and refine outcome measures for future studies.
Study design: This is a pilot/feasibility study being undertaken within the Gynaecology
Department of the Royal Devon and Exeter NHS Foundation Trust (RD&E NHS FT).
Recruitment: It is anticipated that potential participants will be identified from routine
clinical care, with clinicians informing patients of the project in general terms and seeking
permission for their contact details to be passed to the research team. Potential
participants will then be contacted by a member of the research team and given more detailed
verbal and written information. This will then be followed by a further opportunity for
discussion with the research team prior to being invited to participate in the study.
All potential participants who fulfil the entry criteria will be invited to take part. This
will enable a realistic assessment of recruitment and the recruitment strategy.
Procedure: Written informed consent will be obtained prior to any study procedures. This will
include permission to access routinely collected data from the participant's medical notes.
Baseline data will include: height, weight, and current medicines (including routine
analgesia). Participants will be randomised to either the intervention group (General
Anaesthetic (GA) and PNB) or control group (GA alone) by a computer generated randomisation
schedule.
Surgical procedure: Participants will undergo routine posterior vaginal wall surgery
following standard surgical procedures and protocols.
For those randomised to the intervention group - a standardised PNB will be administered
prior to completion of surgery.
Standardised PNB: A PNB will be performed by injection of local anaesthetic around the trunk
of the pudendal nerve, which is located behind the sacrospinous ligament. Using transvaginal
approach, the ischial spines will be palpated posterolateral to the vaginal sidewall. The
sacrospinous ligament is a firm band running medially and posteriorly from the ischial spine
to the sacrum. The needle guide with the needle and syringe containing anaesthetic will be
inserted so the tip lies against the vaginal mucosa about 1 cm medial and posterior to the
ischial spine. When the needle guide gets properly positioned, the needle will be pushed
beyond its tip and through the vaginal mucosa into the sacrospinous ligament. After
aspirating to confirm the absence of an intravascular location, 3 ml of 0.25% bupivacaine
will be injected into the ligament. The needle will then be advanced slightly until the
sensation of resistance caused by the ligament is lost. The needle has to be lodged in the
loose areolar tissue behind the ligament where the pudendal nerve will be located. Aspiration
will again be performed to confirm the absence of an intravascular position (the pudendal and
inferior gluteal vessels lie adjacent to the pudendal nerve), and then the remaining 7 mL of
anaesthetic are injected. The procedure will be repeated on the contralateral side.
Post -op: For all participants the investigators will record: post -operative pain (Visual
Analogue Scale (VAS) score) at 6, 12, 24, 36 and 48 hours, length of bladder catheterisation,
pain associated with defecation and analgesic consumption.
Data Collection and Recording: All participants will be assigned a unique study identifier
(ID) All data collected will be recorded and stored under this ID number. Data will be
initially recorded onto a study specific data collection form (DCF). Data will then be
recorded onto a study specific database. Hard/scanned copies will be stored in the study
specific site file. To ensure data quality, data collected and recorded will be screened and
reviewed for discrepancies and missing data prior to analysis.
Confidentiality: data will be held in a link-anonymised format, with personal identifiable
data only accessible to personnel with training in data protection. Participants' research
and sample data will be identified by unique study ID numbers and all data will be held on
password-protected computers Data Storage and Archiving: All consent and paper data
collection forms will be scanned onto discs and stored in a locked filing cabinet within the
CI's controlled access office in the Centre for Women's Health for the duration of the
project. Paper copies will be shredded. At the end of the project, all study data will be
archived as per standard Research and Development (R&D) department protocol.
Primary Outcome measure: Post- op pain scores as defined by VAS measure Secondary outcome
measures: Length of bladder catheterisation, pain associated with defecation and post-op
analgesic consumption Statistics and Power Calculations: The aim of this study is to obtain
preliminary data and determine the feasibility of a future Randomised Control Trial (RCT),
not to determine clinical differences. The investigators estimate 40 potential participants
will be available over a 9 month period (figures obtained from RD&E Gynaecology Surgery dept.
based on last year's operation lists). The investigators will invite all patients who fulfil
the entry criteria to participate. This will enable us to determine a realistic recruitment
rate and obtain estimates of differences in post-op pain scores to inform a full RCT.
Analysis will be restricted to descriptive statistics only.
Adverse events/patient safety: It is not anticipated that participants involved in this
project will be subject to adverse effects. Pudendal Nerve blocks are very rarely associated
with complications such as anaphylaxis, haematoma and infection at the site of injection,
ischial paraesthesias and systemic toxicity due to intravascular administration. The risk of
these rare complications would apply to any nerve block currently used in routine clinical
practice. The risks will be further minimised by the procedure being carried out by a
Gynaecological Consultant experienced in the procedure, with full anaesthetic and surgical
team back up if required. The CI will be informed of any adverse effects within 24 hours and
they will be reported following local NHS R&D protocols, with a copy of any adverse event
form stored in the project site file.
Subjects will be informed that they are free to withdraw from the study at any time up until
their data are coded but not anonymised. When data are fully anonymised, the participants
will still be able to withdraw but their data will be retained.
During routine clinical care the clinicians involved with the study have had in-depth
discussions with the women in their care including treatment options and the potential
complications associated with surgery. Of particular concern to patients is how much pain
they will be in, leading to the initial idea of the use of PNB to relieve post-op pain.
Resultant anecdotal feedback suggested this resulted in lower post-op pain levels than other
patients in the ward that had similar operations. This led directly to the development of the
current project.
The investigators subsequently discussed the proposal with a cross section of women attending
the pre- and post op Pelvic Organ Prolapse (POP) clinics. All expressed enthusiasm for the
project and a willingness to be involved either as a participant or as a user representative
on any further definitive studies.
Blinding: on recruitment, a member of the clinical surgical team (not a member of the
research team) will open the next in line randomisation envelope and identify to the surgeon
the participant's group allocation. This will then be recorded against the participant's
unique study ID.
Un-blinding: Should a serious, adverse event or clinical situation occur that required a
participant to be un-blinded, that decision will be made by the Chief Investigator (CI) and
reported to the sponsor as per standard R&D Dept. Governance protocol? Time scale: 12 months.
In the short term the study will provide preliminary data to on the impact of administering a
PNB to women undergoing routine posterior vaginal wall surgery. In the longer term this data
will inform a future definitive study into the clinical and economic impact of the routine
use of PNB in this context. Results will be written up and submitted for publication in a
peer-reviewed journal.
