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

NCT04996251 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 21-0422
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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)

  18-24 hours

Secondary Outcomes (1)

• Narcotic Usage

  2 weeks

Study Arms (2)

subcutaneous infiltration pre-incision

EXPERIMENTAL

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

Drug: Bupivacaine Injection

subcutaneous infiltration post-incision

EXPERIMENTAL

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

Drug: Bupivacaine Injection

Interventions

Bupivacaine Injection DRUG

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

subcutaneous infiltration post-incision; subcutaneous infiltration pre-incision

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Vini Chopra Konowitz
• Organization: Northwell Health (previously) now at Advocate Aurora Health

vinichopra924@gmail.com

859-905-8782

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: System Chief of Urogynecology Division; Principal Investigator

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 9, 2021
• Study Start: July 30, 2021
• Primary Completion: May 30, 2023
• Study Completion: June 30, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)