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

Clinical Effectiveness of Pre-incision Versus Post-incision Local Anesthetic During Laparoscopic/Robotic Sacrocolpopexy

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04996251
Acronym
CLAPPS
Enrollment
129
Registered
2021-08-09
Start date
2021-07-30
Completion date
2023-06-30
Last updated
2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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

Interventions

DRUGBupivacaine Injection

0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy

Sponsors

Northwell Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Likert-pain Scale Score on Postoperative Day One18-24 hoursDifference 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

MeasureTime frameDescription
Narcotic Usage2 weeksCompare narcotic usage (pills used) until first postoperative appointment

Countries

United States

Participant flow

Participants by arm

ArmCount
Subcutaneous Infiltration Pre-incision
Marcaine (bupivacaine) injected in the umbilical port site subcutaneously, while in the other 4 sites injection under direct visualization Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
62
Subcutaneous Infiltration Post-incision
local anesthetic infiltrated subcutaneously at the end of the procedure after trocar removal and after skin closure with suture Bupivacaine Injection: 0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
67
Total129

Baseline characteristics

CharacteristicTotalSubcutaneous Infiltration Pre-incisionSubcutaneous Infiltration Post-incision
Age, Continuous62 years62 years62 years
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
129 Participants62 Participants67 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Total number of patients participating129 Participants62 Participants67 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 620 / 67
other
Total, other adverse events
0 / 620 / 67
serious
Total, serious adverse events
0 / 620 / 67

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Subcutaneous Infiltration Pre-incisionLikert-pain Scale Score on Postoperative Day One2.94 units on a scaleStandard Deviation 2.36
Subcutaneous Infiltration Post-incisionLikert-pain Scale Score on Postoperative Day One3.27 units on a scaleStandard Deviation 2.33
Secondary

Narcotic Usage

Compare narcotic usage (pills used) until first postoperative appointment

Time frame: 2 weeks

ArmMeasureValue (MEDIAN)
Subcutaneous Infiltration Pre-incisionNarcotic Usage0 MME
Subcutaneous Infiltration Post-incisionNarcotic Usage0 MME

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026