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

NCT02352922 | Completed Phase 4 Results

• 1 other identifier: 691275
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pain, Postoperative; Surgical Procedure, Unspecified

Keywords

Laparoscopy; Robotic Surgical Procedures; Hysterectomy; Anesthetics, Local; Bupivacaine; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).

  Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable

  24 hours

Secondary Outcomes (14)

• NRS Pain Score at 2 Hours

  2 hours post-op

• NRS Pain Score at 4 Hours

  4 hours post-op

• NRS Pain Score at 8 Hours

  8 hours post-op

• NRS Pain Score at 16 Hours

  16 hours post-op

• NRS Pain Score Post-op Day 2

  2 days post-op

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

extended-release bupivacaine (EXPAREL)

Drug: Liposomal Bupivacaine

Bupivacaine HCl

ACTIVE COMPARATOR

short-acting bupivacaine

Drug: Bupivacaine HCl

Interventions

Liposomal Bupivacaine DRUG

pre-incision infiltration with liposomal bupivacaine

Also known as: Exparel

Liposomal Bupivacaine

Bupivacaine HCl DRUG

pre-incision infiltration with bupivacaine HCl

Also known as: Marcaine

Bupivacaine HCl

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead

Study Sites (1)

Florida Hospital Orlando

Orlando, Florida, 32804, United States

Location

Related Publications (8)

• Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6. doi: 10.1016/s1074-3804(05)60578-6.

  PMID: 11342725 BACKGROUND

• Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5. doi: 10.1016/s0029-7844(98)00303-2.

  PMID: 9840560 BACKGROUND

• Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 12;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2.

  PMID: 24619479 BACKGROUND

• Bergese SD, Onel E, Portillo J. Evaluation of DepoFoam((R)) bupivacaine for the treatment of postsurgical pain. Pain Manag. 2011 Nov;1(6):539-47. doi: 10.2217/pmt.11.62.

  PMID: 24645765 BACKGROUND

• Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.

  PMID: 21842428 BACKGROUND

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 BACKGROUND

• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.

  PMID: 22285545 BACKGROUND

• Kato J, Ogawa S, Katz J, Nagai H, Kashiwazaki M, Saeki H, Suzuki H. Effects of presurgical local infiltration of bupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecologic examinations: a possible preemptive analgesic effect. Clin J Pain. 2000 Mar;16(1):12-7. doi: 10.1097/00002508-200003000-00003.

  PMID: 10741813 BACKGROUND

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

Limitations and Caveats

study published in JMIG. https://doi.org/10.1016/j.jmig.2016.11.002

Results Point of Contact

• Title: Dr. Kenneth I Barron
• Organization: Center for Advanced Gynecology, PLLC

kenneth.barron.md@gmail.com

5088876896

Study Officials

• Georgine Lamvu, MD, MPH

  Florida Hospital Orlando

  PRINCIPAL INVESTIGATOR

• Kenneth I Barron, MD

  Florida Hospital Orlando

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: February 2, 2015
• Study Start: July 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: February 1, 2016
• Last Updated: October 1, 2020
• Results First Posted: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)