Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

Anesthesia Clinical Trial

Official title:

On Postoperative Analgesic Requirements in Laparoscopic Colorectal Surgery Patients After Exparel Administration Via Transversus Abdominis Plane Block Versus Surgical Infiltration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03927326
• Other study ID #: STUDY00007182
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2019
• Est. completion date: July 2020

Study information

• Verified date: April 2019
• Source: University of Washington
• Contact: Alan Chang, MD
• Phone: 714-878-0850
• Email: achang5[@]uw.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

Description:

Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

Exclusion Criteria:

• Patients on chronic pain mediations equaling or exceeding > 25 morphine daily equivalents

• Patients allergic to bupivacaine

• Patients with ASA status IV, V, or VI

• Patients unable to consent

• Patients that are pregnant

• Patients that are incarcerated

• Patients receiving procedures in addition to laparoscopic colorectal procedure

• Patients on systemic anticoagulation precluding them from regional blocks

Related Conditions & MeSH terms

• Anesthesia
• Anesthesia, Local
• Anesthesia; Functional
• Opioid Use
• Pain, Postoperative

Intervention

Drug:
• Exparel 266 MG Per 20 ML Injection
Liposomal bupivacaine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

References & Publications (7)

Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1. — View Citation

Candiotti KA, Sands LR, Lee E, Bergese SD, Harzman AE, Marcet J, Kumar AS, Haas E. Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes. Curr Ther Res Clin Exp. 2013 Dec 27;76:1-6. doi: 10.1016/j.curtheres.2013.12.001. eCollection 2014 Dec. — View Citation

Gastevski D. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical pain management in a 39-year-old female undergoing laparoscopic cholecystectomy. Pain Med. 2014 Aug;15(8):1312-5. doi: 10.1111/pme.12356. Epub 2014 Jan 21. — View Citation

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. — View Citation

Hadzic A, Abikhaled JA, Harmon WJ. Impact of volume expansion on the efficacy and pharmacokinetics of liposome bupivacaine. Local Reg Anesth. 2015 Dec 7;8:105-11. doi: 10.2147/LRA.S88685. eCollection 2015. Review. — View Citation

Mulligan RP, Morash JG, DeOrio JK, Parekh SG. Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty. Foot Ankle Int. 2017 Nov;38(11):1222-1228. doi: 10.1177/1071100717722366. Epub 2017 Aug 8. — View Citation

Sternlicht A, Shapiro M, Robelen G, Vellayappan U, Tuerk IA. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical analgesia in robotic laparoscopic prostatectomy: a pilot study. Local Reg Anesth. 2014 Dec 12;7:69-74. doi: 10.2147/LRA.S64515. eCollection 2014. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour post operative opioid consumption	Listed in morphine daily equivalents.	24 hours postoperative
Secondary	12 hour post operative opioid consumption	Listed in morphine daily equivalents	12 hours postoperative
Secondary	48 hour post operative opioid consumption	Listed in morphine daily equivalents	48 hours postoperative
Secondary	Pain intensity at 12 hours post operative	Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)	12 hours
Secondary	Pain intensity at 24 hours post operative	Self reported pain intensity by visual analog scale scored 0-10 (0 = no pain; 10 = worst pain imaginable)	24 hours
Secondary	Hospital length of stay	How long the patient requires their inpatient stay measured in days.	Until end of hospital stay, typically 3 days