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Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation

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ClinicalTrials.gov Identifier: NCT03664986
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Ricardo Caraballo, MD, Atlantic Health System

Brief Summary:

A pudendal nerve block is a procedure where a local anesthetic is injected where the pudendal nerve is located. This allows quick pain relief to the perineum, vulva, and vagina. The purpose of this research study is see if injecting a long-acting local anesthetic, called Liposomal Bupivacaine (EXPAREL), will result in less post-operative pain after having vaginal prolapse surgery.

Typical post-operative pain lasts a few days. Short-acting anesthetics only provide pain relief in the few hours after surgery. EXPAREL will add the benefit of longer acting pain relief that can last up to 72 hours with the same safety profile. EXPAREL is an FDA-approved medication. It has been used and studied extensively in gynecologic surgery for incisional pain. It has also been studied in Urology and Orthopedic surgery with an excellent safety profile with good pain relief.


Condition or disease Intervention/treatment Phase
Vaginal Prolapse Drug: Liposomal Bupivacaine Phase 4

Detailed Description:

Various clinical studies have indicated that preemptive analgesia can effectively reduce pain as well as analgesic requirements in the post-operative period. Pudendal nerve blockade has been used successfully for multiple urological procedures to prevent post-operative pain. It has also been used in obstetrical practice as a low-risk and low-cost anesthetic technique during repair of obstetrical lacerations.

Postoperative pain after vaginal reconstructive surgery is commonly localized to the vulva, lower vagina, and perineum, originating from the region of the sacrospinous ligament and pelvic floor. Therefore, pudendal nerve blockage has been employed safely during pelvic reconstructive surgery. A study comparing pudendal block with placebo after transvaginal reconstructive surgery did not produce any differences in post-operative pain intensity or the consumption of narcotic analgesia. However, the anesthetic used for the pudendal nerve blockage was short-acting non-liposomal bupivacaine with a half-life of 2.7 hours.

In 2011, a liposomal formulation of bupivacaine, EXPAREL, was approved by the FDA for single-dose infiltration in surgical site to produce postsurgical analgesia. The advantage of using this formulation of bupivacaine is that its analgesic effects can last up to 72 hours. Since the release of EXPAREL, there have been no published studies establishing its use for pudendal block or the management of postoperative pain in Urogynecologic surgery.

The objective of our study is to compare the use of EXPAREL in minimizing post-operative pain after sacrospinous ligament fixation with or without concomitant procedures for pelvic organ prolapse, with or without suburethral sling. We hypothesize that pudendal nerve blockage using long-acting EXPAREL will reduce post-operative pain and potentially reduce oral narcotic consumption. It may also reduce the incidence of postoperative constipation and patient satisfaction.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: The group you get randomized to will be chosen by chance, like flipping a coin. Neither you nor the study doctor will choose what group you will be in. You will have an equal chance of being in either group. Neither you nor the nurses nor anesthesiologist will know which group you will be in. However, your study doctor will know.
Primary Purpose: Treatment
Official Title: Pudendal Block Using Liposomal Bupivacaine vs. Standard Treatment During Sacrospinous Ligament Fixation: a Prospective Randomized Clinical Trial
Actual Study Start Date : September 24, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exparel pudendal block
This group will have intra-operative pudendal block performed with Liposomal Bupivacaine (EXPAREL) solution.
Drug: Liposomal Bupivacaine
The objective of our study is to compare the use of EXPAREL in minimizing post-operative pain after sacrospinous ligament fixation with or without concomitant procedures for pelvic organ prolapse, with or without suburethral sling. We hypothesize that pudendal nerve blockage using long-acting EXPAREL will reduce post-operative pain and potentially reduce oral narcotic consumption. It may also reduce the incidence of postoperative constipation and patient satisfaction.
Other Name: Exparel

No Intervention: Comparison group
This group will be those to receive current standard treatment with no pudendal block performed.



Primary Outcome Measures :
  1. Pain on postoperative day one [ Time Frame: 24 hours post operative ]
    Pain on postoperative day one using the VAS (0 to 10 cm)


Secondary Outcome Measures :
  1. Pain immediately upon transfer from PACU to floor [ Time Frame: up to 4 hours post operative ]
    Pain immediately upon transfer from PACU to floor using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  2. Pain at the time of answering survey each day [ Time Frame: Daily post-op days 1-3 and 7 ]
    Pain at the time of answering survey each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  3. Most intense pain each day [ Time Frame: Daily post-op days 1-3 and 7 ]
    Most intense pain each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  4. Average pain each day [ Time Frame: Daily post-op days 1-3 and 7 ]
    Average pain each day [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  5. Pain with sitting [ Time Frame: Daily post-op days 1-3 and 7 ]
    Pain with sitting [Time frame: post-operative days 1-3 and 7] using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  6. Pain with first bowel movement [ Time Frame: At time of first bowel movement ]
    Pain with first bowel movement using VAS (0 to 10 cm). (Self-reported via survey or telephone call)

  7. Total narcotic consumption [ Time Frame: up to 30 days post operative ]
    Total narcotic consumption

  8. Urinary retention [ Time Frame: up to 30 days post operative ]
    Incidence of Urinary Retention

  9. Time to first bowel movement [ Time Frame: up to 10 days post-operative ]
    Time to first bowel movement

  10. Ambulatory Quality of Life questionnaire (QoR) [ Time Frame: up to 24 hours before surgery and 72 hours post operative ]
    Quality of Life as measured by the ambulatory QoR [Time frame: pre-operative on the day of surgery and post-operative day 3].



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age >18 years
  • Female
  • Able to give informed consent in English
  • Electively scheduled for surgical management of pelvic organ prolapse involving sacrospinous ligament fixation

Exclusion Criteria:

  • Pregnant or nursing
  • Allergy to amide anesthetics
  • History of opioid abuse
  • Severe cardiovascular, hepatic, renal disease or neurological impairment
  • Long-acting opioid within 30 days or any opioid use within 24 hours before surgery
  • Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
  • Administration of an investigational drug within 30 days before this study
  • Chronic pain syndromes
  • Daily NSAID or opioid use
  • Contraindication to Non-steroidal anti-inflammatory drugs (NSAIDs)

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): NCT03664986


Contacts
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Contact: Ricardo Caraballo, MD 973-971-7267 ricardo.caraballo@atlantichealth.org
Contact: Caroline Sabatino, MPH, CCRP 973-971-7361 caroline.sabatino@atlantichealth.org

Locations
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United States, New Jersey
Atlantic Health System Recruiting
Morristown, New Jersey, United States, 07960
Contact: Caroline Sabatino, MPH, CCRP         
Principal Investigator: Ricardo Caraballo, MD         
Sponsors and Collaborators
Atlantic Health System

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Responsible Party: Ricardo Caraballo, MD, Principal Investigator, Atlantic Health System
ClinicalTrials.gov Identifier: NCT03664986     History of Changes
Other Study ID Numbers: 1191772
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: September 2018
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

Additional relevant MeSH terms:
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Prolapse
Uterine Prolapse
Pathological Conditions, Anatomical
Uterine Diseases
Genital Diseases, Female
Pelvic Organ Prolapse
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents