Clinical trial NCT05044429: Postoperative Pain Control Following Renal Transplant
Official title: Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant; Complications
Pain, Postoperative
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to compare the effectiveness of a regional anesthetic block vs systemic intravenous (IV) lidocaine in controlling post-operative pain in kidney transplantation patients. Regional anesthetic blocks and lidocaine infusions are effective alternatives to opioid medications and are already in use at many institutions. However, there has been no prospective study comparing their effectiveness when used in conjunction with the current standard of care patient controlled analgesia (PCA) pumps. This study is a prospective, randomized evaluation of both treatment methods.

Detailed description: Adequate postoperative pain control is an important part of the patients' recovery. Renal transplant patients often have multiple comorbidities, that when combined with poorly controlled postoperative pain, can lead to tachycardia, hypertension, and increased risk of respiratory complications, which can in turn affect overall recovery and graft survival.

The use of patient-controlled analgesia (PCA) pumps is currently considered the standard of care in treating surgical pain in the immediate postoperative period. Although a traditional mainstay of therapy, opioids have an unfavorable side effect profile that includes respiratory depression, nausea, postoperative ileus, sedation, and pruritus. Additionally, long-term opioid use is linked with opioid tolerance, addiction, and patient death. Patients that have high-level opioid use in the first year posttransplant have been found to have high rates of death and all-cause graft failure.

Recently, there has been a shift in post-operative pain management to utilize a multimodal approach of both non-pharmacologic and pharmacologic therapies. As a result, the use of other non-opioid therapies, such as lidocaine infusions and regional anesthetic techniques, like transverse abdominis plane blocks, have recently increased in popularity in perioperative pain management of renal transplant patients.

Intravenous lidocaine has an off label indication as analgesic and has good evidence for use in other areas such as colorectal surgery, trauma and orthopedics. Lidocaine infusions have a strong record of safety with relatively benign adverse side effects. Although data is promising, there is little established evidence of perioperative lidocaine infusions in renal transplant populations.

Transverse abdominis plane (TAP) blocks and quadratus lumborum (QL) blocks have emerged as a significant regional technique in the application of multimodal analgesia for abdominal surgeries. Historically, TAP and QL catheters are avoided due to concern about infection near the operative site in immunosuppressed transplant patients. Establishing intravenous lidocaine as an effective treatment option will allow physicians to avoid the side effects of opioids and the infection risks of TAP and QL catheter blocks.

Eligibility criteria: Inclusion Criteria:

* Unilateral renal transplant

Exclusion Criteria:

* History of chronic pain, chronic opioid use, or opioid use disorder
* Cardiac arrythmia, cardiac failure
* Hepatic Failure
* Local anesthetic allergy (allergy to lidocaine and ropivacaine)
* Complicated surgical course including intraoperative damage to other organs (bowel)
* Return to operating room within 72hours

Primary outcomes:
measure: Opioid Utilization (12 Hour Post-operative)
timeFrame: 12 hours after surgery
measure: Opioid Utilization (24 Hour Post-operative)
timeFrame: 24 hours after surgery
measure: Opioid Utilization (36 Hour Post-operative)
timeFrame: 36 hours after surgery
measure: Opioid Utilization (48 Hour Post-operative)
timeFrame: 48 hours after surgery
measure: Pain Level (12 Hour Post-operative)
timeFrame: 12 hours after surgery
measure: Pain Level (24 Hour Post-operative)
timeFrame: 24 hours after surgery
measure: Pain Level (36 Hour Post-operative)
timeFrame: 36 hours after surgery
measure: Pain Level (48 Hour Post-operative)
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Number of Subjects With Postoperative Sepsis
timeFrame: Through hospital discharge, approximately three days
measure: Number of Acute Rejection of Renal Transplant
timeFrame: Up to one week
measure: Number of Subjects With Local Anesthetic Systemic Toxicity (LAST)
timeFrame: Through hospital discharge, approximately four days
measure: Number of Patients Who Need Continuous Veno-venous Hemodiafiltration (CVVHDF) After Renal Transplant
timeFrame: By time of hospital discharge, approximately four days
measure: Number of Patients With Symptoms of Opioid Toxicity After Renal Transplant
timeFrame: Through hospital discharge, approximately four days
measure: Number of Patients With Ileus After Renal Transplant
timeFrame: Through hospital discharge, approximately four days
measure: Total Length of Hospital Stay
timeFrame: Through hospital discharge, approximately four days
measure: Length of Intensive Care Unit Stay
timeFrame: Through hospital discharge, approximately four days
measure: Vital Status
timeFrame: Through hospital discharge, approximately four days
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
Study officials:
References:
citation: Farag E, Guirguis MN, Helou M, Dalton JE, Ngo F, Ghobrial M, O'Hara J, Seif J, Krishnamurthi V, Goldfarb D. Continuous transversus abdominis plane block catheter analgesia for postoperative pain control in renal transplant. J Anesth. 2015 Feb;29(1):4-8. doi: 10.1007/s00540-014-1855-1. Epub 2014 Jun 5.
citation: Beaussier M, Delbos A, Maurice-Szamburski A, Ecoffey C, Mercadal L. Perioperative Use of Intravenous Lidocaine. Drugs. 2018 Aug;78(12):1229-1246. doi: 10.1007/s40265-018-0955-x.
citation: Rahendra R, Pryambodho P, Aditianingsih D, Sukmono RB, Tantri A, Melati AC. Comparison of IL-6 and CRP Concentration Between Quadratus Lumborum and Epidural Blockade Among Living Kidney Donors: A Randomized Controlled Trial. Anesth Pain Med. 2019 Apr 28;9(2):e91527. doi: 10.5812/aapm.91527. eCollection 2019 Apr.