Phase 4 N=70 Randomized Double-blind Supportive Care

Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse

Pelvic Organ Prolapse

Bottom Line

View on ClinicalTrials.gov: NCT02449915 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively — 15.0; 20.5 mm — p=0.52

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bupivacaine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: TriHealth Inc.
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively	15.0; 20.5	0.52

Summary

To determine if the injection of liposomal bupivacaine to laparoscopic port sites and rectocele repair incisions at the completion of a robotic sacrocolpopexy with concomitant rectocele repair will result in decreased postoperative pain compared to injection of placebo.

Eligibility Criteria

Inclusion Criteria

Adults 18 years of age or older
Planning for surgical treatment of POP with robotic sacrocolpopexy and rectocele repair under general anesthesia
Patient undergoing concurrent hysterectomy and/or sub-urethral sling will be included

Exclusion Criteria

Pregnant or nursing
Allergy to bupivacaine
History of drug/alcohol abuse
Severe cardiovascular, hepatic, renal disease, or neurological impairment
Long-acting opioid use within 3 days or any opioid use within 24 hours before surgery
Contraindication to: acetaminophen, oxycodone, non-steroidal anti- inflammatory drugs (NSAID)
Administration of an investigational drug within 30 days before study
Chronic pain syndromes
Daily NSAID/opioid use
Patients not undergoing general anesthesia
Patients undergoing concurrent transvaginal mesh removal, anal sphincteroplasty, or fistula repair

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02449915). 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.