Enhanced Recovery After Surgery in Kidney Transplant Donors

NCT04110080 | Unknown DMC

• 1 other identifier: 19D.574
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Enhanced recovery after surgery (ERAS) pathways are designed to optimize perioperative management, improving patient outcomes and satisfaction through multimodal techniques. Living kidney transplant donors are typically healthy individuals who undergo laparoscopic nephrectomy. The most significant hindrance to discharge to return to activities of daily living is frequently return of bowel function and postoperative pain. Through a randomized controlled trial design, we will evaluate the effectiveness of implementing an ERAS pathway. We hypothesize that preoperative patient optimization through exercise, carbohydrate loading, and counseling on expectations, in addition to multimodal pain management strategies which limit opioids would allow faster recovery, early bowel function, decreased postoperative pain, increased patient satisfaction and shorter length of stay. The study population will include a total of 42 patients (age 18-80) who are American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3, undergoing living donor nephrectomy. Our primary outcome measures will be postoperative opioid consumption. Secondary outcome measures are: postoperative pain score, time to return of bowel function, ambulation, first oral intake postoperatively, and patient satisfaction scores. Other objectives include reducing readmissions, shorter hospital length of stay and decreased operative complications, including nausea, vomiting and wound infection.

Conditions

Opioid Use; Kidney Diseases; Pain, Postoperative; Postoperative Complications; Postoperative Nausea and Vomiting

Keywords

enhanced recovery after surgery; living donor kidney transplant; multimodal analgesia

Outcome Measures

Primary Outcomes (1)

• post operative opioid consumption

  amount of opioid pain medication required post operatively

  from time after discharge from PACU to discharge from the hospital (up to 7 days)

Secondary Outcomes (4)

• duration of hospitalization

  from arrival on day of surgery to discharge from hospital (up to 7 days, anticipated 3 days)

• time to return of bowel function

  arrival to PACU until discharge from hospital (up to 7 days)

• time to first oral intake

  from arrival to PACU until post-operative day 2 (48 hours)

• patient satisfaction

  from discharge from PACU post operative day one to discharge home on last day of hospitalization (up to 7 days)

Study Arms (2)

Enhanced recovery after surgery

EXPERIMENTAL

Preoperatively, patients will be counseled on optimization of physical and nutritional status. They will receive carbohydrate loading drinks prior to surgery. Intraoperatively, standard ASA monitors will be utilized, and patients will receive general anesthesia. Goal directed fluid management will be enforced with bolus options based on hemodynamics. Transabdominal plane and rectus sheath block will be performed in the operating room by the regional anesthesia team. Post-operatively pain management will include multimodal analgesic medications. Regular diet will be allowed and encouraged on post-operative day 0 (POD). Lines and drains will be minimized to encourage early mobilization and bowel function. Patients will be counseled on expectations of discharge criteria POD0.

Procedure: multimodal pain management; Other: goal directed fluid management; Other: preoperative carbohydrate loading; Procedure: Donor nephrectomy; Procedure: regional anesthesia

Standard of care

ACTIVE COMPARATOR

Patients will receive traditional care for donor nephrectomy. Patients will be instructed to fast for 24 hours preoperative. On day of surgery, standard monitors will be used, and intraoperative management per anesthesiologists discretion including pain management. Post-operative, patients will receive pain medications, including opioids, as needed. Intravenous fluids will be continued until patients tolerate liquids per os. Bowel regimen will be ordered as needed. Patients will be discharged once meeting pre-set criteria.

Procedure: Donor nephrectomy

Interventions

multimodal pain management PROCEDURE

Regional anesthesia techniques, specifically rectus sheath and transabdominal plane blocks, for pain management will be performed.

Enhanced recovery after surgery

goal directed fluid management OTHER

Intraoperatively fluids will be administered based on hemodynamic parameters, in addition to clinical judgement.

Enhanced recovery after surgery

preoperative carbohydrate loading OTHER

Patient's nutrition will be optimized preoperatively by administering carbohydrate drinks, and limiting fasting time.

Enhanced recovery after surgery

Donor nephrectomy PROCEDURE

All patient will have laparoscopic nephrectomy procedure with transplant surgery.

Enhanced recovery after surgery; Standard of care

regional anesthesia PROCEDURE

transabdominal plane and rectus sheath nerve block

Enhanced recovery after surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing this procedure who consent

You may not qualify if:

• patient refusal, female patients who are pregnant or nursing, patients with allergy to local anesthetic, American Society of Anesthesiology classification greater than 3

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19102, United States

RECRUITING

Related Publications (9)

• Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.

  PMID: 28097305 BACKGROUND

• Smith MD, McCall J, Plank L, Herbison GP, Soop M, Nygren J. Preoperative carbohydrate treatment for enhancing recovery after elective surgery. Cochrane Database Syst Rev. 2014 Aug 14;2014(8):CD009161. doi: 10.1002/14651858.CD009161.pub2.

  PMID: 25121931 BACKGROUND

• Nemati E, Einollahi B, Lesan Pezeshki M, Porfarziani V, Fattahi MR. Does kidney transplantation with deceased or living donor affect graft survival? Nephrourol Mon. 2014 Jul 5;6(4):e12182. doi: 10.5812/numonthly.12182. eCollection 2014 Jul.

  PMID: 25695017 BACKGROUND

• Rege A, Leraas H, Vikraman D, Ravindra K, Brennan T, Miller T, Thacker J, Sudan D. Could the Use of an Enhanced Recovery Protocol in Laparoscopic Donor Nephrectomy be an Incentive for Live Kidney Donation? Cureus. 2016 Nov 22;8(11):e889. doi: 10.7759/cureus.889.

  PMID: 28018759 BACKGROUND

• McEvoy MD, Scott MJ, Gordon DB, Grant SA, Thacker JKM, Wu CL, Gan TJ, Mythen MG, Shaw AD, Miller TE; Perioperative Quality Initiative (POQI) I Workgroup. American Society for Enhanced Recovery (ASER) and Perioperative Quality Initiative (POQI) joint consensus statement on optimal analgesia within an enhanced recovery pathway for colorectal surgery: part 1-from the preoperative period to PACU. Perioper Med (Lond). 2017 Apr 13;6:8. doi: 10.1186/s13741-017-0064-5. eCollection 2017.

  PMID: 28413629 BACKGROUND

• Meyer LA, Lasala J, Iniesta MD, Nick AM, Munsell MF, Shi Q, Wang XS, Cain KE, Lu KH, Ramirez PT. Effect of an Enhanced Recovery After Surgery Program on Opioid Use and Patient-Reported Outcomes. Obstet Gynecol. 2018 Aug;132(2):281-290. doi: 10.1097/AOG.0000000000002735.

  PMID: 29995737 BACKGROUND

• Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8.

  PMID: 24368573 BACKGROUND

• Ni X, Jia D, Chen Y, Wang L, Suo J. Is the Enhanced Recovery After Surgery (ERAS) Program Effective and Safe in Laparoscopic Colorectal Cancer Surgery? A Meta-Analysis of Randomized Controlled Trials. J Gastrointest Surg. 2019 Jul;23(7):1502-1512. doi: 10.1007/s11605-019-04170-8. Epub 2019 Mar 11.

  PMID: 30859422 BACKGROUND

• Halawa A, Rowe S, Roberts F, Nathan C, Hassan A, Kumar A, Suvakov B, Edwards B, Gray C. A Better Journey for Patients, a Better Deal for the NHS: The Successful Implementation of an Enhanced Recovery Program After Renal Transplant Surgery. Exp Clin Transplant. 2018 Apr;16(2):127-132. doi: 10.6002/ect.2016.0304. Epub 2017 Aug 24.

  PMID: 28836932 BACKGROUND

MeSH Terms

Conditions

Kidney Diseases; Pain, Postoperative; Postoperative Complications; Postoperative Nausea and Vomiting

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Uzong Yoon, MD, MPH

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Neiswinter, MD

CONTACT

7176794438; natalie.neiswinter@jefferson.edu

Uzong Yoon, MD, MPH

CONTACT

215-955-6161; uzung.yoon@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: October 1, 2019
• Study Start: September 12, 2019
• Primary Completion: June 12, 2023
• Study Completion: June 12, 2023
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)