A Phase 4 interventional study of Bupivacaine Injection in Pain, Postoperative, sponsored by Northwell Health. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Northwell Health · Phase 4, Interventional, and Prevention
Obtaining Likest-pain scale score on postoperative day one after injection of local anesthetic into incision sites of a laparoscopic/robotic-assisted sacrocolpopexy
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
5,224 studies on the registry are indexed under Pain, Postoperative; 1,154 are open to participants now.
This study's enrollment of 129 is above the median of 75 across 4,457 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Northwell Health is the lead sponsor of 473 studies on the registry; 106 are open to participants now.
Of its 43 completed or terminated interventional studies of FDA-regulated products, 22 (51%) have results posted.
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Females 18+ years old who are undergoing robotic/laparoscopic assisted sacrocolpopexy
With/without anterior/posterior vaginal repair
Exclusion Criteria:
Females \< 18 years old
Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization
Drug: Bupivacaine Injection
local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture
Drug: Bupivacaine Injection
0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
Also known as: Marcaine
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)
Time frame: 18-24 hours
Narcotic Usage
Compare narcotic usage (pills used) until first postoperative appointment
Time frame: 2 weeks
| Milestone | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision |
|---|---|---|
| Started | 62 | 67 |
| Completed | 62 | 67 |
| Not completed | 0 | 0 |
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)
| units on a scale | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision |
|---|---|---|
| Likert-pain Scale Score on Postoperative Day One | 2.94 ± 2.36 | 3.27 ± 2.33 |
Compare narcotic usage (pills used) until first postoperative appointment
| MME | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision |
|---|---|---|
| Narcotic Usage | 0 (0 to 16.9) | 0 (0 to 22.5) |
Collected over 23 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subcutaneous Infiltration Pre-incision | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| Subcutaneous Infiltration Post-incision | 0/67 (0%) | 0/67 (0%) | 0/67 (0%) |
| Age, Continuous(years) | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision | Total |
|---|---|---|---|
| Median | 62 (57.8 to 66) | 62 (53.3 to 67.8) | 62 (53.3 to 67.8) |
| Sex: Female, Male(Participants) | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision | Total |
|---|---|---|---|
| Female | 62 | 67 | 129 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Total number of patients participating(Participants) | Subcutaneous Infiltration Pre-incision | Subcutaneous Infiltration Post-incision | Total |
|---|---|---|---|
| Count of participants | 62 | 67 | 129 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — No plan to share individual participant data (IPD) with any other researchers.
Ran from Jul 2021 to primary completion in May 2023, 22 months.
Results were first posted in Dec 2024, 1 year 6 months after primary completion.
Of 492 non-industry phase 4 interventional studies under Pain, Postoperative, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's 22 months is above that.
Counting every sponsor, half of 497 studies reached it within 15 months; a quarter within 8 and three quarters within 31.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Bupivacaine