Pain, Postoperative Clinical Trial
Official title:
TAP Blocks Performed With Bupivacaine Versus Liposomal Bupivacaine in Colorectal Surgery Patients: A Prospective, Cluster Randomized Trial
Verified date | April 2019 |
Source | Inova Health Care Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Inova Health Care Services |
United States,
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
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). |
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