Pelvic Organ ProlapsePAINSNCT04733560
Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension
A study testing Pudendal nerve block and Bupivacaine Injectable Product in people with Pelvic Organ Prolapse, run by Fraser Health at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Pudendal nerve block and Bupivacaine Injectable Product
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2021to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
City Centre Obstetrics and Gynecology
Surrey, British Columbia, V3V 0C6
Sophia Badowski, 6138889851, slenson@qmed.ca
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Pudendal nerve block, Sham Pudendal nerve block, Bupivacaine Injectable Product
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
Vaginally administered pudendal nerve block of 10ml 0.25% Bupivacaine prior to making any surgical incisions.
Sham Pudendal nerve blockProcedure or surgery
Vaginally administered pudendal nerve block of 10ml Normal Saline prior to making any surgical incisions.
Bupivacaine Injectable ProductDrug
Used for pudendal nerve block in the intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Pudendal nerve block | Experimental | 25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions. Receives: Procedure: Pudendal nerve block; Drug: Bupivacaine Injectable Product |
| Placebo | Sham comparator | 25 women will receive sham pudendal nerve blocks using normal saline. These will also be administed vaginally prior to making any surgical incisions. Receives: Procedure: Sham Pudendal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Score
measured on a Visual Analog scale (1-10)
Measured: measured at post-operative day 0
Post-operative Pain Score
measured on a Visual Analog scale (1-10)
Measured: measured at post-operative day 1
Post-operative Pain Score
measured on a Visual Analog scale (1-10)
Measured: measured at post-operative day 14
Secondary outcomes (7)
Readiness for discharge
measured on a 5 point Likert scale
Measured: measured at post-operative day 0 prior to discharge
Patient satisfaction
measured on a 5 point Likert scale
Measured: measured at postoperative day 0
Patient satisfaction
measured on a 5 point Likert scale
Measured: measured at postoperative day 1
Patient satisfaction
measured on a 5 point Likert scale
Measured: measured at postoperative day 14
Functional Recovery Index
Validated tool by Wong et al. Involving measures of return to activities of daily living
Measured: measured at postoperative day 1
Functional Recovery Index
Validated tool by Wong et al. Involving measures of return to activities of daily living
Measured: measured at postoperative day 14
Post-operative Analgesic use
pill count
Measured: measured at postoperative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Apr 2021
- Primary completionMar 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fraser Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sophia Badowski, Fraser Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733560
- Sponsor's protocol ID
- FHREB2020-143
- Acronym
- PAINS
- Status last verified
- Oct 2021
- First submitted
- 25 Jan 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Analgesia by Infiltration of the Pudendal Nerve Prior to Sacrospinous Ligament Suspension: The PAIN-S Trial
- ClinicalTrials.gov ID
- NCT04733560
- Acronym / sponsor ID
- PAINS / FHREB2020-143
- Conditions
- Pelvic Organ Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Fraser HealthUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| Pudendal nerve block | Experimental | Procedure: Pudendal nerve block, Drug: Bupivacaine Injectable Product25 women will receive pudendal nerve blocks of 0.25% Bupivicaine 10ml administered vaginally prior to making any surgical incisions. |
| Placebo | Sham comparator | Procedure: Sham Pudendal nerve block25 women will receive sham pudendal nerve blocks using normal saline. These will also be administed vaginally prior to making any surgical incisions. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve blockVaginally administered pudendal nerve block of 10ml 0.25% Bupivacaine prior to making any surgical incisions. | Procedure or surgery | Pudendal nerve block |
| Sham Pudendal nerve blockVaginally administered pudendal nerve block of 10ml Normal Saline prior to making any surgical incisions. | Procedure or surgery | Placebo |
| Bupivacaine Injectable ProductUsed for pudendal nerve block in the intervention arm | Drug | Pudendal nerve block |
Primary outcome
Post-operative Pain Score
Time frame: measured at post-operative day 0
measured on a Visual Analog scale (1-10)
Post-operative Pain Score
Time frame: measured at post-operative day 1
measured on a Visual Analog scale (1-10)
Post-operative Pain Score
Time frame: measured at post-operative day 14
measured on a Visual Analog scale (1-10)
7 secondary outcomes
Readiness for discharge
Time frame: measured at post-operative day 0 prior to discharge
Patient satisfaction
Time frame: measured at postoperative day 0
Patient satisfaction
Time frame: measured at postoperative day 1
Patient satisfaction
Time frame: measured at postoperative day 14
Functional Recovery Index
Time frame: measured at postoperative day 1
Functional Recovery Index
Time frame: measured at postoperative day 14
Post-operative Analgesic use
Time frame: measured at postoperative day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Pelvic Organ Prolapse
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal nerve block and Bupivacaine Injectable Product in people with Pelvic Organ Prolapse, run by Fraser Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophia Badowski, MD (6138889851, slenson@qmed.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Score (time frame: measured at post-operative day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.