Postoperative Pain Control Following Renal Transplant
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intravenous Lidocaine
|
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)
|
| Active Comparator: Transversus abdominis plane (TAP) block
|
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)
|
| Active Comparator: Quadratus Lumborum (QL) Block
|
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)
|
Outcome Measures
Primary Outcome Measures
- Opioid utilization (12 hour post-operative) [12 hours after surgery]
Measured in oral morphine equivalents
- Opioid utilization (24 hour post-operative) [24 hours after surgery]
Measured in oral morphine equivalents
- Opioid utilization (36 hour post-operative) [36 hours after surgery]
Measured in oral morphine equivalents
- Opioid utilization (48 hour post-operative) [48 hours after surgery]
Measured in oral morphine equivalents
- Pain level (12 hour post-operative) [12 hours after surgery]
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
- Pain level (24 hour post-operative) [24 hours after surgery]
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
- Pain level (36 hour post-operative) [36 hours after surgery]
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
- Pain level (48 hour post-operative) [48 hours after surgery]
Measured using visual analog scale (0-10), 0 is the best and 10 is the worst
Secondary Outcome Measures
- Sepsis [Through hospital discharge, approximately three days]
Post-operative infection that requires intravenous antibiotics
- Acute rejection of transplant [Up to one week]
Occurs when the immune system identifies a grafted organ as foreign and attacks it
- Local Anesthetic Systemic Toxicity (LAST) [Through hospital discharge, approximately four days]
A life-threatening adverse reaction resulting from local anesthetic reaching significant systemic circulating levels
- Continuous veno-venous hemodiafiltration (CVVHDF) [By time of hospital discharge, approximately four days]
Temporary treatment for patients with acute renal failure
- Opioid toxicity [Through hospital discharge, approximately four days]
Opioid toxicity requiring naloxone
- Ileus [Through hospital discharge, approximately four days]
Painful obstruction of the ileum or other part of the intestine
- Total length of hospital stay [Through hospital discharge, approximately four days]
Transplant time to discharge time
- Length of intensive care unit stay [Through hospital discharge, approximately four days]
Number of days spent in the intensive care unit following transplant
- Vital status [Through hospital discharge, approximately four days]
Alive or dead at time of hospital discharge
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | George Washington University Hospital | Washington | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- George Washington University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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.
- 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.
- NCR202221