Clinical trial NCT04110080: Enhanced Recovery After Surgery in Kidney Transplant Donors
Official title: Enhanced Recovery After Surgery in Living Donor Kidney Transplant Donors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Kidney Diseases
Pain, Postoperative
Postoperative Complications
Postoperative Nausea and Vomiting
Keywords: enhanced recovery after surgery
living donor kidney transplant
multimodal analgesia
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2019-10-01
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: ERAS pathways have been widely used in multiple surgical disciplines leading to improvements in perioperative care. The goal of the pathways is to decrease postoperative opioid consumption, improve pain scores, decrease length of hospital stay, lower morbidity, and increase patient satisfaction. Living kidney donors are in high demand and represent a large portion of grafts supplied for kidney transplant. The primary objective of our study is to initiate an enhanced recovery after surgery pathway designed to facilitate early recovery and to study the impact of an ERAS protocol on the living donor nephrectomy population.

The study is a prospective, randomized, controlled clinical trial evaluating the effect of ERAS to decrease postoperative opioid consumption, improve pain scores, decrease length of hospital stay, lower morbidity, and increase patient satisfaction. Patients will complete standard preoperative workup as per protocol for donor nephrectomy, and they will also be evaluated at the preadmission testing clinic. Consent will be obtained by a member of the research team at a preoperative office visit. At this time, patients will be randomized to enhanced recovery after surgery (ERAS) pathway or standard of care, and they will be informed on what to expect during their hospital course.

ERAS pathway:

Preoperatively, according to the ERAS pathway devised, patients will be counseled on optimization of physical status. They will be encouraged to sustain from smoking and alcohol, exercise daily, and encourage healthy diet. If the physician determines the need for nutritional counsel, they will have a workup by a nutritionist. They will also be labeled as ERAS pathway in the case request submitted by the surgeon. For the day of surgery, patients will receive carbohydrate drinks and dietary instructions. All patients will be instructed to have a clear liquid diet 24 hours prior to surgery with no food after midnight. Patients will receive 2 carbohydrate pre-surgery drinks (20 oz total) - 10oz for the night before surgery, and 10oz to drink within 1 hour of scheduled arrival time. On arrival the day of surgery, patients will receive the following medications, unless contraindicated or allergy: acetaminophen 1g PO, pregabalin 150 mg PO, and celecoxib 400 mg PO.

Patients will be evaluated in the preoperative holding area by a member of the anesthesiology staff. Peripheral IV will be placed. Patients will be screened for risk of post-operative nausea and vomiting (PONV) (female, nonsmoker, prior PONV, planned postoperative opioid each 1 point), if deemed high risk a scopolamine patch will be applied in holding. Patients will at that point be counseled on use of regional anesthesia for postoperative pain and additional consent for transabdominal plane and rectus sheath blocks will be obtained. Premedication with midazolam will be administered. Subcutaneous heparin 5000 units will be given prior to surgery, as per standard of care.

Intraoperatively, standard ASA monitors will be utilized, and patients will receive general anesthesia with propofol, fentanyl, rocuronium (dosed by weight), and sevoflurane maintenance for all patients. Additional IV access will be established. Antibiotics will be administered within 1 hour of incision per protocol. Goal directed fluid management with Plasmalyte or Lactated ringers with goal of 3-4 ml/kg/hr ideal body weight, with bolus option for clinical indications of MAP \< 65mmHg. If requiring more than 2 boluses of 200-250 ml, phenylephrine infusion will be used for hypotension. Additional antiemetic prophylaxis will be given: ondansetron 4mg for all patients with the addition of dexamethasone 10 mg if high risk of PONV. At the end of the case, ketorolac 15 mg will be given.

The transabdominal plane and rectus sheath block will be performed in the operating room by the regional anesthesia team, after the skin is closed and dressings are applied but while the patient is still under general anesthesia. An ultrasound guided approach will be used to identify the plane between the internal oblique and transversus abdominis muscles. Twenty ml (10 ml each side) of 0.375% ropivacaine will be injected to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). For the rectus sheath block the ultrasound transducer will be positioned immediately lateral to umbilicus and 20 ml (10 ml each side) of 0.375% ropivacaine local anesthetic will be injected between rectus muscle and posterior rectus sheath.

Following extubation, patients will return to post-anesthesia care unit (PACU) and be discharged to their inpatient room per standard guidelines. Phenergan 6.25 mg IV BID or ondansetron 4mg IV q8 will be administered as needed for PONV. Additional pain management will includes ketorolac 15mg q6 for 48 hours post operatively, acetaminophen 1g q6, pregabalin 75mg BID. If refractory pain, tramadol 50mg q6 hours for breakthrough will be offered once taking PO, hydromorphone 0.2mg IV q2 as needed will be available if refractory pain and unable to take PO post operative day 0 (POD0). Regular diet will be allowed and encouraged on POD0. IV fluids will be given until POD1, and urine will be monitored q1 hour for the first 12 hours after which point the foley catheter will be removed. Subcutaneous heparin will be started POD1. Patients will also be given a bowel regimen consisting of docusate, senna glycoside and polyethylene glycol. If no bowel movement by POD1 and opioid use by patient, methylnaltrexone bromide will be administered. Patients will be encouraged to be out of bed (OOB) and ambulating as soon as possible POD0. Discharge criteria will be discussed and enforced with patient POD0.

Standard of care:

Preoperatively, patients will be randomly assigned to the standard of care. They will be instructed for clear liquid diet 24 hours prior to surgery with no food/liquid after midnight. On the day of surgery, they will receive subcutaneous heparin 5000 units as standard of care. They will have peripheral IV placed and be interview by the anesthesiology team in the preoperative holding area.

Intraoperatively, standard ASA monitors will be utilized and patients will receive general anesthesia with propofol, fentanyl, rocuronium (dosed by weight), and sevoflurane maintenance for all patients. Additional IV access will be established. Antibiotics will be administered within 1 hour of incision per protocol. Fluid management and hemodynamics will be treated as clinically indicated. All patients will receive ondansetron 4mg IV at the conclusion of the case for prevention of PONV.

Postoperatively, patients will return to PACU. Hydromorphone 0.2mg IV q30 minutes will be available for postoperative pain, and promethazine 6.25 mg IV BID or ondansetron 4mg IV q8 will be administered as needed for PONV. On return to the floor, IV fluids will be continued until patient is tolerating PO. Diet will be advanced per patient tolerance. IV hydromorphone 0.5mg q4 hours as needed will be available until patient is tolerating PO at which point oxycodone 5-10mg q4 as needed will be available for pain. Bowel regimen will be administered as needed, ambulation will be encouraged, and vital signs and urine output will be monitored per standard of care.

All patients will be discharged according to following criteria: independent ambulation, tolerating PO, baseline hemodynamics with urine output \> 0.5 ml/kg/hr and adequate pain control with oral medications.

To assess the efficacy of the ERAS pathway, data collected will include postoperative pain scores and opioid use, time to first PO diet, time to return of bowel function, postoperative complications, incidence of PONV, and length of hospital stay. Patient satisfaction will be evaluated by the research team on the last day of hospitalization with a patient experience questionnaire (attached). Additionally, pain scores at follow-up appointments, additional hospitalizations and complications will be documented.

Eligibility criteria: 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

Primary outcomes:
measure: post operative opioid consumption
timeFrame: from time after discharge from PACU to discharge from the hospital (up to 7 days)
Secondary outcomes:
measure: duration of hospitalization
timeFrame: from arrival on day of surgery to discharge from hospital (up to 7 days, anticipated 3 days)
measure: time to return of bowel function
timeFrame: arrival to PACU until discharge from hospital (up to 7 days)
measure: time to first oral intake
timeFrame: from arrival to PACU until post-operative day 2 (48 hours)
measure: patient satisfaction
timeFrame: from discharge from PACU post operative day one to discharge home on last day of hospitalization (up to 7 days)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Uzong Yoon, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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