Recruiting

Enhanced Recovery

Sponsor:

Thomas Jefferson University

Code:

NCT04110080

Conditions

Opioid Use

Kidney Diseases

Pain, Postoperative

Postoperative Complications

Postoperative Nausea and Vomiting

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

multimodal pain management

goal directed fluid management

preoperative carbohydrate loading

Donor nephrectomy

regional anesthesia

Study Details

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

Study ID

NCT04110080

Start date

Sep 12, 2019

Status verified date

Apr, 2023

Completion date

Jun 12, 2023

Anticipated

Primary completion date

Jun 12, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All patients undergoing this procedure who consent

Exclusion Criteria:

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

Study Design

Enrollment

42 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhanced recovery after surgery

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.

active comparator: Standard of care

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.

Interventions

multimodal pain management

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

goal directed fluid management

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

preoperative carbohydrate loading

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

Donor nephrectomy

All patient will have laparoscopic nephrectomy procedure with transplant surgery.

regional anesthesia

transabdominal plane and rectus sheath nerve block

Primary outcome measure

  • post operative opioid consumption [ Time Frame: from time after discharge from PACU to discharge from the hospital (up to 7 days) ]

Central Contacts and Locations

Central contacts

Natalie Neiswinter, MD

7176794438natalie.neiswinter@jefferson.edu

Uzong Yoon, MD, MPH

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

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19102

Contacts

Natalie R Neiswinter, MD

717-679-4438natalie.neiswinter@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Apr 18, 2023

Last verified

Apr, 2023

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2023-04-18.