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Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040011
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : February 24, 2020
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Magee-Womens Research Institute
Information provided by (Responsible Party):
Lauren Giugale, MD, University of Pittsburgh

Brief Summary:

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed.

The study population will be adult women (>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).


Condition or disease Intervention/treatment Phase
Pelvic Organ Prolapse Surgery Postoperative Pain Drug: Dexamethasone Drug: Bupivacaine Procedure: Bilateral Pudendal Nerve Block Procedure: Bilateral Levator Ani Muscle Injection Drug: Saline Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three-arm, double-blinded, placebo-controlled, randomized controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded
Primary Purpose: Treatment
Official Title: Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block With Bupivacaine and Dexamethasone for Improved Pain Control After Vaginal Reconstructive Surgery: A Three-Arm Randomized Controlled Trial
Actual Study Start Date : June 1, 2017
Actual Primary Completion Date : April 11, 2019
Actual Study Completion Date : August 5, 2019


Arm Intervention/treatment
Experimental: Bupivacaine/Dexamethasone Arm
After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.
Drug: Dexamethasone
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Other Name: Decadron

Drug: Bupivacaine
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Other Name: Marcaine

Procedure: Bilateral Pudendal Nerve Block
Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.

Procedure: Bilateral Levator Ani Muscle Injection
Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.

Active Comparator: Bupivacaine Arm
After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.
Drug: Bupivacaine
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Other Name: Marcaine

Procedure: Bilateral Pudendal Nerve Block
Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.

Procedure: Bilateral Levator Ani Muscle Injection
Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.

Placebo Comparator: Placebo Arm
After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.
Procedure: Bilateral Pudendal Nerve Block
Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.

Procedure: Bilateral Levator Ani Muscle Injection
Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.

Drug: Saline
Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
Other Name: Normal Saline




Primary Outcome Measures :
  1. Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS) [ Time Frame: 24 hours postoperatively ]
    Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.


Secondary Outcome Measures :
  1. 6 Hour Postoperative Pain Measured by the NRS [ Time Frame: 6 hours postoperatively ]

    Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

    Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.


  2. POD 2 Postoperative Pain Measured by the NRS [ Time Frame: 2 days after surgery ]
    Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

  3. POD 3 Postoperative Pain Measured by the NRS [ Time Frame: 3 days after surgery ]
    Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

  4. 1 Week Postoperative Pain Measured by the NRS [ Time Frame: 1 week after surgery ]
    Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

  5. Proportion of Patients With Same Day Discharge [ Time Frame: Day of surgery ]
    Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.

  6. Postoperative Urinary Retention [ Time Frame: 0-24 hours postoperatively ]
    Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.

  7. Adverse Events [ Time Frame: 0-12 weeks postoperatively ]
    The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.

  8. Nausea and Vomiting Measured by the PONV Scale [ Time Frame: 6 hours postoperatively ]
    Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.

  9. Anti-emetic Consumption [ Time Frame: 3 hours postoperatively ]
    The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication

  10. Return to Baseline Activities Using the Activities Assessment Scale [ Time Frame: 1 week postoperative ]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

    We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.


  11. Return to Baseline Activities Using the Activities Assessment Scale [ Time Frame: 2 week postoperative ]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

    We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.


  12. Return to Baseline Activities Using the Activities Assessment Scale [ Time Frame: 6 weeks postoperative ]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

    We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.


  13. Return to Baseline Activities Using the Activities Assessment Scale [ Time Frame: 12 weeks postoperative ]

    Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

    We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.


  14. POD 1 Narcotic Consumption [ Time Frame: Postoperative day 1 ]
    The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.

  15. POD 2 Narcotic Consumption [ Time Frame: Postoperative day 2 ]
    The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.

  16. POD 3 Narcotic Consumption [ Time Frame: Postoperative day 3 ]
    The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.

  17. POD 1 Ibuprofen Consumption [ Time Frame: Postoperative day 1 ]
    The total amount of ibuprofen medication used on postoperative day 1.

  18. POD 2 Ibuprofen Consumption [ Time Frame: Postoperative day 2 ]
    The total amount of ibuprofen medication used on postoperative day 2.

  19. POD 3 Ibuprofen Consumption [ Time Frame: Postoperative day 3 ]
    The total amount of ibuprofen medication used on postoperative day 3.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Women ages 18 or older who are scheduled for a vaginal native tissue repair with apical support procedure including uterosacral ligament suspension, sacrospinous ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy
  2. Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies , perineorrhaphies and midurethral sling placements are acceptable and do not result in exclusion
  3. Available for at least 12 weeks of follow-up
  4. Able to undergoing general anesthesia

Exclusion Criteria:

  1. Planned mesh-augmented apical support procedure (placement of synthetic midurethral sling is acceptable and not considered an exclusion criteria)
  2. Planned mesh excision
  3. Laparoscopic, robotic or abdominal surgery
  4. Known adverse reaction or allergy to intervention medication
  5. Evidence of fistula or known infection (vulvovaginal cellulitis, abscess, abdominopelvic infection, or systemic fungal infection)
  6. Chronic pelvic pain as an active issue
  7. Daily opiate consumption for any indication
  8. History of pelvic radiation
  9. Chronic steroid use
  10. Diabetes mellitus
  11. Known HIV/AIDS or immunosuppression secondary to transplant related medications
  12. Planned surgery under regional anesthesia
  13. Non-English speaking or inability to complete questionnaires
  14. Bleeding disorders that would impair a patient's clotting ability
  15. Weight less than 50kg

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): NCT03040011


Locations
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United States, Pennsylvania
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Lauren Giugale, MD
Magee-Womens Research Institute
Investigators
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Principal Investigator: Lauren Giugale, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Lauren Giugale, MD, University of Pittsburgh:
Informed Consent Form  [PDF] November 6, 2018

Publications:
Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.
Bupivacaine: Drug Information. UpToDate; 2016.
Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.

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Responsible Party: Lauren Giugale, MD, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03040011    
Other Study ID Numbers: PRO16110378
First Posted: February 1, 2017    Key Record Dates
Results First Posted: February 24, 2020
Last Update Posted: March 9, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Lauren Giugale, MD, University of Pittsburgh:
Vaginal Surgery
Pelvic Organ Prolapse
Postoperative Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Prolapse
Pelvic Organ Prolapse
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Pathological Conditions, Anatomical
Dexamethasone
Bupivacaine
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents