NCT05044429

Postoperative Pain Control Following Renal Transplant

Postoperative Pain Control With Systemic Lidocaine vs. Regional Anesthesia in Renal Transplant Patients

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: George Washington University · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant; Complications
• Pain, Postoperative

Interventions

Type	Name	Description
DRUG	Intravenous Lidocaine	Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
DRUG	Transversus abdominis plane (TAP) block	Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
DRUG	Quadratus Lumborum (QL) Block	Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)

Timeline

• Start date: 2021-03-16
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2021-09-14
• Last updated: 2024-03-18
• Results posted: 2024-03-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study