Enhanced Recovery After Surgery in Kidney Transplant Donors

NCT04110080 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

PROCEDURE

multimodal pain management

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

OTHER

goal directed fluid management

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

OTHER

preoperative carbohydrate loading

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

PROCEDURE

Donor nephrectomy

All patient will have laparoscopic nephrectomy procedure with transplant surgery.

PROCEDURE

regional anesthesia

transabdominal plane and rectus sheath nerve block

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Uzong Yoon, MD, MPH · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-12
Primary Completion
2023-06-12
Completion
2023-06-12

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04110080 on ClinicalTrials.gov