Standard Bupivacaine vs Liposomal Bupivacaine in Colorectal Patients

Pain, Postoperative Clinical Trial

Official title:

TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03638635
• Other study ID #: 17-2725
• Status: Terminated
• Phase: Phase 4
• Start date: May 14, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: April 2019
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Pain control is a factor that is central to the surgical patient's postoperative experience. Opioid pain medications are a mainstay of postoperative pain management. However, these have several adverse effects.

Multimodal pain regimens to minimize opioid use have become central to enhanced recovery after surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is one intervention that contributes to this regimen. Traditionally, TAP blocks are performed with local anesthetics such as bupivacaine. More recently, these have also been performed with liposomal bupivacaine, whose duration of action is much greater than regular bupivacaine (96 hours versus 8-9 hours, respectively).

In this study, postoperative opioid usage will be compared between patients receiving regular bupivacaine and liposomal bupivacaine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 63
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Undergoing elective colectomy by surgeons of Fairfax Colon and Rectal Surgery

Exclusion Criteria:

• Allergic to local anesthetics

• Unable to provide consent

• Pregnant

• On opioids at home chronically (Patients previously on a regular opioid regimen would need to be opioid-free for a period of 1 year for inclusion in the study)

• Undergoing emergent operations

• Undergoing loop ileostomy reversal

• Undergoing abdominoperineal resection, pelvic exenteration, or perineal rectal prolapse repairs

Related Conditions & MeSH terms

• Colectomy
• Colorectal Surgery
• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Bupivacaine
Abdominal injection of bupivacaine into fascial layer.
• Bupivacaine liposome
Abdominal injection of bupivacaine liposome into fascial layer.

Locations

Country	Name	City	State
United States	Fairfax Colon & Rectal Surgery, Alexandria Office	Alexandria	Virginia
United States	Fairfax Colon & Rectal Surgery, Fair Oaks Office	Fairfax	Virginia
United States	Fairfax Colon & Rectal Surgery, Fairfax-Prosperity Office	Fairfax	Virginia
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	Fairfax Colon & Rectal Surgery, Loudoun Office	Lansdowne Town Center	Virginia
United States	Fairfax Colon & Rectal Surgery, Reston Office	Reston	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Inova Health Care Services

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rafi AN. Abdominal field block: a new approach via the lumbar triangle. Anaesthesia. 2001 Oct;56(10):1024-6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital Postoperative Opioid Consumption	Daily overall opioid use recorded as morphine equivalents	up to postoperative day 3 at 1 pm
Secondary	Pain Score	Recorded on a scale of 0 (No pain) to 10 (Worst possible pain)	Approximately every 6 hours through postoperative day 3 by 1 pm
Secondary	Time to Patient Mobilization	Number of days from day of surgery until 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).
Secondary	Time to Return of Bowel Function	Number of days from time of surgery until 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).
Secondary	Time to Clear Liquid Diet	Number of days from time of surgery until patient tolerates 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).
Secondary	Time to Low Fiber Diet	Number of days from day of surgery until patient tolerates 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).
Secondary	Length of Stay	Total postoperative hospital stay in days	Date of surgery to date of discharge (usually up to 4 days after surgery).
Secondary	In-hospital Antiemetic Use	Amount of ondansetron patient required postoperatively during hospital stay, in milligrams	Time of transfer to post operative suite to time of discharge (usually up to 4 days after surgery).
Secondary	Complications	Patient suffered a complication (infection, small bowel obstruction, dehydration, deep vein thrombosis/pulmonary embolism, anastomotic leak, cardiac arrest, stroke, sepsis) after surgery	Within 30 days of surgery
Secondary	Readmissions	Patient readmitted to hospital after discharge	Within 30 days of hospital discharge
Secondary	Mortality	Patient death after surgery	Within 30 days of surgery
Secondary	Hospitalization Costs	Total hospitalization costs per patient per this surgical encounter	From date of this surgical admission to date of this surgical discharge (usually up to 4 days after surgery).