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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel pudendal block | Experimental | This group will have intra-operative pudendal block performed with Liposomal Bupivacaine (EXPAREL) solution. |
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| Comparison group | No Intervention | This group will be those to receive current standard treatment with no pudendal block performed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivacaine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain on postoperative day one | Pain on postoperative day one using the VAS (0 to 10 cm) | 24 hours post operative |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at the time of answering survey each day | 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) | Daily post-op days 1-3 and 7 |
| Most intense pain each day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Caraballo, MD | Contact | 973-971-7267 | ricardo.caraballo@atlantichealth.org | |
| Caroline Sabatino, MPH, CCRP | Contact | 973-971-7361 | caroline.sabatino@atlantichealth.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantic Health System | Recruiting | Morristown | New Jersey | 07960 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37450670 | Derived | Ezzedine D, Dhariwal L, Wasenda E, Salamon C, Caraballo R. Pudendal Nerve Block With Liposomal Bupivacaine for Sacrospinous Ligament Suspension. Urogynecology (Phila). 2024 Feb 1;30(2):98-106. doi: 10.1097/SPV.0000000000001397. Epub 2023 Jul 13. |
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| ID | Term |
|---|---|
| D014596 | Uterine Prolapse |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
|
|
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) |
| Daily post-op days 1-3 and 7 |
| Average pain each day | 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) | Daily post-op days 1-3 and 7 |
| Pain with sitting | 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) | Daily post-op days 1-3 and 7 |
| Pain with first bowel movement | Pain with first bowel movement using VAS (0 to 10 cm). (Self-reported via survey or telephone call) | At time of first bowel movement |
| Total narcotic consumption | Total narcotic consumption | up to 30 days post operative |
| Urinary retention | Incidence of Urinary Retention | up to 30 days post operative |
| Time to first bowel movement | Time to first bowel movement | up to 10 days post-operative |
| Ambulatory Quality of Life questionnaire (QoR) | Quality of Life as measured by the ambulatory QoR [Time frame: pre-operative on the day of surgery and post-operative day 3]. | up to 24 hours before surgery and 72 hours post operative |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |