Phase 4 N=64 Randomized Double-blind Treatment

Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

Pain, Postoperative · Surgical Procedure, Unspecified

Bottom Line

View on ClinicalTrials.gov: NCT02352922 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1). — 4.17; 4.97 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Liposomal Bupivacaine (Drug); Bupivacaine HCl (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: AdventHealth
Primary completion: Jan 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).	4.17; 4.97	—
SECONDARY NRS Pain Score at 2 Hours	2.53; 2.74	—
SECONDARY NRS Pain Score at 4 Hours	3.87; 3	—
SECONDARY NRS Pain Score at 8 Hours	3.77; 3.67	—
SECONDARY NRS Pain Score at 16 Hours	3.1; 3.97	—
SECONDARY NRS Pain Score Post-op Day 2	3.34; 4.17	—
SECONDARY NRS Pain Score Post-op Day 3	2.79; 4.07	—
SECONDARY NRS Pain Score Post-op Day 14	1.64; 2.07	—
SECONDARY Quality of Life as Measured by the Brief Pain Inventory (BPI)	1.74; 1.65	—
SECONDARY Quality of Life as Measured by the Brief Pain Inventory (BPI)	1.74; 1.65	—
SECONDARY Quality of Life as Measured by the Brief Pain Inventory (BPI)	1.74; 1.65	—
SECONDARY Total Opioid Use Prior to Hospital Discharge	216; 266	—
SECONDARY Total Opioid Use End of Post-op Day 3	320; 344	—
SECONDARY Total Opioid Use at Post-op Day 14	360; 443	—
SECONDARY Number of Participants With Adverse Events	5; 9; 5; 2; 4; 6	—

Summary

The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.

Eligibility Criteria

Inclusion Criteria

Benign indication for surgery
Planned multiport laparoscopic or robotic assisted hysterectomy
Non-pregnant
Able to provide informed consent
Owns smartphone or computer with internet access
Willing to provide contact phone number and accept SMS text messages
Ability to speak and read English (because texts and online surveys will be in English only)

Exclusion Criteria

Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)
Contraindication to study drug
Severe Hepatic disease
Severe Kidney disease
Current use of monoamine oxidase inhibitors
Current use of tricyclic antidepressants
History of substance or alcohol abuse within the past 2 years

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02352922). 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.