Phase 4 N=129 Randomized Single-blind Prevention

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

Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT04996251 ↗

Enrolled (actual)

129

Serious AEs

0.0%

Results posted

Dec 2024

Primary outcome: Primary: Likert-pain Scale Score on Postoperative Day One — 2.94; 3.27 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine Injection (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Northwell Health
Primary completion: May 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Likert-pain Scale Score on Postoperative Day One	2.94; 3.27	—
SECONDARY Narcotic Usage	0; 0	—

Summary

Obtaining Likest-pain scale score on postoperative day one after injection of local anesthetic into incision sites of a laparoscopic/robotic-assisted sacrocolpopexy

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04996251). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.