Phase 4
Completed N=70
Improvement of Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse
Source: ClinicalTrials.gov NCT02449915 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Dec 2017
Primary outcomePrimary: Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively — 15.0; 20.5 mm — p=0.52
◆ Published Evidence
Established
32citations · ~4 / year
Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial.
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.
Linked Publications
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Liposomal Bupivacaine During Robotic Colpopexy and Posterior Repair: A Randomized Controlled Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively |
15.0; 20.5 | 0.52 |
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
Data sourced from ClinicalTrials.gov (NCT02449915) and the linked publication. 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. Informational only — not medical advice.