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

• Sponsor: TriHealth Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02449915
• Collaborator: (none)
• Enrollment: 70
• Location: 1
• Arms: 2
• Duration (Months): 17.1
• Patients Per Site Per Month: 4.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Drug: Bupivacaine; Drug: Placebo	Phase 4

Detailed Description

In the last 20 years, laparoscopic surgery has assumed an important role in gynecological surgery. Unfortunately, patient surveys indicate there has been little improvement in the incidence and severity of postsurgical pain in the past two decades. Postoperative pain is a common complaint, occurring in 5-15% of patients and has been shown to significantly contribute to overall patient dissatisfaction. It can lead to increased consumption of opioids, with subsequent nausea, delayed bowel function, and prolonged postoperative recovery. In an attempt to address pain related complications with port-site wounds, various methods of pain control have been attempted. Currently, no standard of care exists and management is based on surgeon and anesthesiologist preferences.

This study seeks 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Does Liposomal Bupivacaine Improve Pain Following Robotic Sacrocolpopexy and Rectocele Repair for Pelvic Organ Prolapse? A Randomized Placebo Controlled Trial
• Study Start Date: Mar 1, 2015
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine Arm Those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).	Drug: Bupivacaine; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).; Other Names: Exparel
Placebo Comparator: Placebo Arm Those subjects in the placebo arm will have 30 mL sterile normal saline injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected into the port site wounds in the abdomen (5 sites, 4 mL per incision).	Drug: Placebo; At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).; Other Names: Normal Saline

Outcome Measures

Primary Outcome Measures

1. Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively [18 hours after surgery]

   VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Urogynecology Associates	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

• TriHealth Inc.

Investigators

• Principal Investigator: Rachel Pauls, MD, Cincinnati Urogynocolgy Associates

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: TriHealth Inc.
• ClinicalTrials.gov Identifier: NCT02449915
• Other Study ID Numbers: 14-079
• First Posted: May 20, 2015
• Last Update Posted: Dec 8, 2017
• Last Verified: Nov 1, 2017

• Keywords provided by TriHealth Inc.: sacrocolpopexy; rectocele repair
• Additional relevant MeSH terms: Rectocele; Prolapse; Pelvic Organ Prolapse; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Bupivacaine Arm	Placebo Arm
Arm/Group Description	Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)	Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
Period Title: Overall Study
STARTED	35	35
COMPLETED	33	31
NOT COMPLETED	2	4

Baseline Characteristics

Arm/Group Title	Bupivacaine Arm	Placebo Arm	Total
Arm/Group Description	Receiving 30mL dilutional volume of the liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)	Receiving 30 mL sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)	Total of all reporting groups
Overall Participants	33	31	64
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	64	61	62
Sex/Gender, Customized (Count of Participants)
Female only	33 100%	31 100%	64 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 3.2%	1 1.6%
Not Hispanic or Latino	33 100%	30 96.8%	63 98.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	33 100%	31 100%	64 100%

Outcome Measures

1. Primary Outcome

Title	Visual Analog Scales (VAS) for Pain at 18 Hours Postoperatively
Description	VAS is a validated 100 millimeter scale with no pain as 0 mm and worst pain as 100 mm. Subjects drew a vertical line on the scale corresponding to their pain level.
Time Frame	18 hours after surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bupivacaine Arm	Placebo Arm
Arm/Group Description	Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)	Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
Measure Participants	33	31
Median (Inter-Quartile Range) [mm]	15.0	20.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Bupivacaine Arm, Placebo Arm
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	From time of surgery to 12 weeks after surgery
Arm/Group Title	Bupivacaine Arm		Placebo Arm
Arm/Group Description	Receiving 30mL dilutional volume of liposomal bupivacaine at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)		Receiving 30 mL volume of sterile normal saline at the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure)
All Cause Mortality
	Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/31 (0%)
Serious Adverse Events
	Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/31 (0%)
Other (Not Including Serious) Adverse Events
	Bupivacaine Arm		Placebo Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/31 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.