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Pre-incision Versus Post-incision Local Anesthetic During Robotic Sacrocolpopexy (CLAPPS)

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine Injection
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Females 18+ years old who are undergoing robotic/laparoscopic assisted sacrocolpopexy

    • With/without hysterectomy
    • With/without unilateral/bilateral salpingectomy
    • With/without unilateral/bilateral oophorectomy
    • With/without mid-urethral sling
    • With/without anterior/posterior vaginal repair

      • English or Spanish speaking
      • Weight ≥ 120 lb

Exclusion Criteria:

  • Females < 18 years old

    • Chronic pelvic pain/chronic pain syndromes
    • Fibromyalgia
    • Pregnant or breastfeeding patients
    • Concomitant procedure for hernia repair or rectal prolapse repair
    • Undergoing primary vaginal prolapse surgery
    • Contraindications to taking the following medications: Bupivacaine
    • Patients who weight is < 120lb
    • Hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formulation
    • Pudendal or spinal nerve block given during surgery

Sites / Locations

  • North Shore University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

subcutaneous infiltration pre-incision

subcutaneous infiltration post-incision

Arm Description

Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization

local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture

Outcomes

Primary Outcome Measures

Likert-pain scale score on postoperative day one
Difference in Likert-pain scale score difference between pre-incision versus post-incision subcutaneous infiltration with 4-5 milliliters 0.25% Bupivacaine (0 is no pain; 10 is worst pain imaginable)

Secondary Outcome Measures

Narcotic Usage
Compare narcotic usage (pills used) until first postoperative appointment
Brief Pain Inventory
Compare brief pain inventory questionnaire survey responses at first postoperative visit

Full Information

First Posted
August 2, 2021
Last Updated
August 4, 2023
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04996251
Brief Title
Pre-incision Versus Post-incision Local Anesthetic During Robotic Sacrocolpopexy
Acronym
CLAPPS
Official Title
Clinical Effectiveness of Pre-incision Versus Post-incision Local Anesthetic During Laparoscopic/Robotic Sacrocolpopexy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 30, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health

4. Oversight

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.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Obtaining Likest-pain scale score on postoperative day one after injection of local anesthetic into incision sites of a laparoscopic/robotic-assisted sacrocolpopexy
Detailed Description
Pelvic organ prolapse is becoming more common as women's life expectancy is increasing and the prevalence of obesity is rising. Many women undergo pelvic reconstructive surgery to treat their prolapse and improve their quality of life. The incidence of pelvic organ prolapse is 1.5-1.8 surgeries per 1,000 women years. Approximately 300,000 pelvic reconstructive surgeries are performed each year in the United States. There is a wide variety in surgical approaches and procedures for prolapse. One such procedure is a sacrocolpopexy in which the cervix or vaginal cuff is lifted to the anterior longitudinal ligament overlying the sacrum via a mesh graft. This can be done in a minimally invasive fashion with a laparoscopic or robotic approach or in an open abdominal approach. Numerous studies have shown this procedure to have a high success rate and long-term durability. As robotic/laparoscopic approach to surgery has shown shorter hospital-stays and improved patient outcomes, the robotic-assisted sacrocolpopexy has been rapidly incorporated into clinical practice. In general, surgery causes a release of painful chemical mediators which has led to increased narcotic use, increased narcotic addiction, and number of pills prescribed. Most individuals who undergo surgery will require narcotics postoperatively to control their pain and some individuals have to extend their hospital stay until adequate pain control is achieved. Our study is aimed to reduce narcotic use, decrease hospital stay due to pain issues and determine if timing of adjunct pain medication improves pain scales for patients. As postoperative pain after minimally invasive surgery is complex, specialists suggest that the effective analgesic treatment should be a multimodal approach. Use of local anesthetic with bupivacaine at robotic/laparoscopic trocar sites is the standard of care, however, there is no standard as to optimal timing that is most beneficial for patients to decrease pain. Currently, bupivacaine is used by providers at the trocar sites at either the beginning of the case or at the end of the case. From clinical observation, it appears that postoperative pain levels reported from patients receiving either at the beginning of surgery (pre-) or end (post-incision) of the surgery are similar. This study aims to examine the difference in postoperative day one pain levels reported by patients between the two infiltration methods

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subcutaneous infiltration pre-incision
Arm Type
Experimental
Arm Description
Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization
Arm Title
subcutaneous infiltration post-incision
Arm Type
Experimental
Arm Description
local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Injection
Other Intervention Name(s)
Marcaine
Intervention Description
0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
Primary Outcome Measure Information:
Title
Likert-pain scale score on postoperative day one
Description
Difference in Likert-pain scale score difference between pre-incision versus post-incision subcutaneous infiltration with 4-5 milliliters 0.25% Bupivacaine (0 is no pain; 10 is worst pain imaginable)
Time Frame
18-24 hours
Secondary Outcome Measure Information:
Title
Narcotic Usage
Description
Compare narcotic usage (pills used) until first postoperative appointment
Time Frame
2 weeks
Title
Brief Pain Inventory
Description
Compare brief pain inventory questionnaire survey responses at first postoperative visit
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Females 18+ years old who are undergoing robotic/laparoscopic assisted sacrocolpopexy With/without hysterectomy With/without unilateral/bilateral salpingectomy With/without unilateral/bilateral oophorectomy With/without mid-urethral sling With/without anterior/posterior vaginal repair English or Spanish speaking Weight ≥ 120 lb Exclusion Criteria: Females < 18 years old Chronic pelvic pain/chronic pain syndromes Fibromyalgia Pregnant or breastfeeding patients Concomitant procedure for hernia repair or rectal prolapse repair Undergoing primary vaginal prolapse surgery Contraindications to taking the following medications: Bupivacaine Patients who weight is < 120lb Hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formulation Pudendal or spinal nerve block given during surgery
Facility Information:
Facility Name
North Shore University Hospital
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share individual participant data (IPD) with any other researchers.

Learn more about this trial

Pre-incision Versus Post-incision Local Anesthetic During Robotic Sacrocolpopexy

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