Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

NCT03638635 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 17-2725
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief Summary

The transversus abdominis plane (TAP) block can be used to reduce pain in patients who get abdominal surgery. TAP blocks are given with a local anesthetic. The purpose of this study is to compare pain medication usage after surgery between two different types of local anesthetic: liposomal bupivacaine and standard bupivacaine.

Conditions

Opioid Use; Pain, Postoperative; Colectomy; Colorectal Surgery

Keywords

Bupivacaine; Exparel; TAP Block; Opioids; Narcotics; ERAS

Outcome Measures

Primary Outcomes (1)

• In-hospital Postoperative Opioid Consumption

  Daily overall opioid use recorded as morphine equivalents

  up to postoperative day 3 at 1 pm

Secondary Outcomes (11)

• Pain Score

  Approximately every 6 hours through postoperative day 3 by 1 pm

• Time to Patient Mobilization

  From time of surgery until time of first patient ambulation post op. Assessed until date of discharge (usually up to 4 days after surgery).

• Time to Return of Bowel Function

  From time of surgery until first time patient passes gas or stool per rectum or into ostomy bag. Assessed until date of discharge (usually up to 4 days after surgery).

• Time to Clear Liquid Diet

  From time of surgery until first time patient tolerates clear liquids without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).

• Time to Low Fiber Diet

  From time of surgery until first time patient tolerates a low fiber diet without nausea or vomiting. Assessed until date of discharge (usually up to 4 days after surgery).

Study Arms (2)

Standard Bupivacaine

ACTIVE COMPARATOR

Standard (0.25% bupivacaine) bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

Drug: Bupivacaine

Bupivacaine Liposome

EXPERIMENTAL

Liposomal bupivacaine (133 mg in 10mL, diluted with 20 mL saline) will be injected into the fascial layer between the internal oblique and the transversus abdominis with ultrasound guidance, 30 mL per side for a total of 60 mL.

Drug: Bupivacaine liposome

Interventions

Bupivacaine DRUG

Abdominal injection of bupivacaine into fascial layer.

Also known as: Marcaine

Standard Bupivacaine

Bupivacaine liposome DRUG

Abdominal injection of bupivacaine liposome into fascial layer.

Also known as: Exparel

Bupivacaine Liposome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

You may not qualify if:

• Allergic to local anesthetics
• Unable to provide consent
• Pregnant
• Undergoing emergent operations
• Undergoing loop ileostomy reversal
• Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Sponsors & Collaborators

• Inova Health Care Services: lead

Study Sites (6)

Fairfax Colon & Rectal Surgery, Alexandria Office

Alexandria, Virginia, 22304, United States

Location

Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office

Fairfax, Virginia, 22031, United States

Location

Fairfax Colon & Rectal Surgery, Fair Oaks Office

Fairfax, Virginia, 22033, United States

Location

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

Location

Fairfax Colon & Rectal Surgery, Loudoun Office

Lansdowne Town Center, Virginia, 20176, United States

Location

Fairfax Colon & Rectal Surgery, Reston Office

Reston, Virginia, 20190, United States

Location

Related Publications (13)

• Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. doi: 10.1046/j.1365-2044.2001.02279-40.x. No abstract available.

  PMID: 11576144 BACKGROUND

• Young MJ, Gorlin AW, Modest VE, Quraishi SA. Clinical implications of the transversus abdominis plane block in adults. Anesthesiol Res Pract. 2012;2012:731645. doi: 10.1155/2012/731645. Epub 2012 Jan 19.

  PMID: 22312327 BACKGROUND

• Rashid A, Gorissen KJ, Ris F, Gosselink MP, Shorthouse JR, Smith AD, Pandit JJ, Lindsey I, Crabtree NA. No benefit of ultrasound-guided transversus abdominis plane blocks over wound infiltration with local anaesthetic in elective laparoscopic colonic surgery: results of a double-blind randomized controlled trial. Colorectal Dis. 2017 Jul;19(7):681-689. doi: 10.1111/codi.13578.

  PMID: 27943522 BACKGROUND

• Oh TK, Yim J, Kim J, Eom W, Lee SA, Park SC, Oh JH, Park JW, Park B, Kim DH. Effects of preoperative ultrasound-guided transversus abdominis plane block on pain after laparoscopic surgery for colorectal cancer: a double-blind randomized controlled trial. Surg Endosc. 2017 Jan;31(1):127-134. doi: 10.1007/s00464-016-4941-7. Epub 2016 Apr 29.

  PMID: 27129571 BACKGROUND

• Walter CJ, Maxwell-Armstrong C, Pinkney TD, Conaghan PJ, Bedforth N, Gornall CB, Acheson AG. A randomised controlled trial of the efficacy of ultrasound-guided transversus abdominis plane (TAP) block in laparoscopic colorectal surgery. Surg Endosc. 2013 Jul;27(7):2366-72. doi: 10.1007/s00464-013-2791-0. Epub 2013 Feb 7.

  PMID: 23389068 BACKGROUND

• Favuzza J, Delaney CP. Outcomes of discharge after elective laparoscopic colorectal surgery with transversus abdominis plane blocks and enhanced recovery pathway. J Am Coll Surg. 2013 Sep;217(3):503-6. doi: 10.1016/j.jamcollsurg.2013.03.030. Epub 2013 Jun 28.

  PMID: 23810575 BACKGROUND

• Ris F, Findlay JM, Hompes R, Rashid A, Warwick J, Cunningham C, Jones O, Crabtree N, Lindsey I. Addition of transversus abdominis plane block to patient controlled analgesia for laparoscopic high anterior resection improves analgesia, reduces opioid requirement and expedites recovery of bowel function. Ann R Coll Surg Engl. 2014 Nov;96(8):579-85. doi: 10.1308/003588414X13946184900921.

  PMID: 25350178 BACKGROUND

• Barron KI, Lamvu GM, Schmidt RC, Fisk M, Blanton E, Patanwala I. Wound Infiltration With Extended-Release Versus Short-Acting Bupivacaine Before Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2017 Feb;24(2):286-292. doi: 10.1016/j.jmig.2016.11.002. Epub 2016 Nov 14.

  PMID: 27856385 BACKGROUND

• Morales R Jr, Mentz H 3rd, Newall G, Patronella C, Masters O 3rd. Use of abdominal field block injections with liposomal bupivicaine to control postoperative pain after abdominoplasty. Aesthet Surg J. 2013 Nov 1;33(8):1148-53. doi: 10.1177/1090820X13510720. Epub 2013 Nov 8.

  PMID: 24214950 BACKGROUND

• Haas E, Onel E, Miller H, Ragupathi M, White PF. A double-blind, randomized, active-controlled study for post-hemorrhoidectomy pain management with liposome bupivacaine, a novel local analgesic formulation. Am Surg. 2012 May;78(5):574-81. doi: 10.1177/000313481207800540.

  PMID: 22546131 BACKGROUND

• Knudson RA, Dunlavy PW, Franko J, Raman SR, Kraemer SR. Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital. Dis Colon Rectum. 2016 Sep;59(9):862-9. doi: 10.1097/DCR.0000000000000648.

  PMID: 27505115 BACKGROUND

• Hutchins JL, Kesha R, Blanco F, Dunn T, Hochhalter R. Ultrasound-guided subcostal transversus abdominis plane blocks with liposomal bupivacaine vs. non-liposomal bupivacaine for postoperative pain control after laparoscopic hand-assisted donor nephrectomy: a prospective randomised observer-blinded study. Anaesthesia. 2016 Aug;71(8):930-7. doi: 10.1111/anae.13502. Epub 2016 May 30.

  PMID: 27238859 BACKGROUND

• Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.

  PMID: 28059913 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

Early termination due to lack of resources leading to incomplete data.

Results Point of Contact

• Title: Erica Emery
• Organization: Inova Health System

erica.emery@inova.org

703-776-7615

Study Officials

• Donald Colvin, MD

  Inova Health Care System

  PRINCIPAL INVESTIGATOR

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
• Masking Details: The participant and the floor nursing staff recording pain scores will be blinded to the assigned intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to receive either standard bupivacaine or liposomal bupivacaine.

Study Record Dates

• First Submitted: August 21, 2017
• First Posted: August 20, 2018
• Study Start: May 14, 2018
• Primary Completion: January 16, 2019
• Study Completion: January 16, 2019
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)