Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Unilateral Nephrectomy. (QoR)

University Hospital of Split

Status and phase

Completed

Phase 4

Conditions

Quality of Life

Patient Satisfaction

Postoperative Period

Anesthesia Recovery Period

Epidural

Nephrectomy

Analgesia

Anesthesia

Treatments

Procedure: Epidural anesthesia with light general anesthesia

Drug: Continuous intravenous analgesia

Procedure: Postoperative epidural analgesia

Procedure: General anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT04521556

2181-147-01/06/M.S.-19-2.

Details and patient eligibility

About

Different modality of anesthesia and analgesia could influence a postoperative quality of recovery (QoR). This study is exploring early QoR after unilateral nephrectomy in the two groups of anesthesia. The first group had a light general anesthesia with thoracic epidural anesthesia and postoperative epidural analgesia with morphine and ropivacaine. The second group had general anesthesia and a continuous postoperative analgesia with tramadol. The postoperative QoR was evaluated 24 hours after surgery.

Full description

All participants were premedicated with diazepam 5 mg 12 hours and 1 hour before surgery. Thromboprophylaxis ( 4,000 - 6000 IU) depending on the body weight was given at least 12 hours before surgery. All participants were warmed to prevent unintended hypothermia. Participants were allocated by permuted-block randomisation into one of two groups: general anesthesia group and epidural anesthesia. The randomisation list was obtained from R program version 3.5.3. The group allocations were contained in a closed envelope that were opened before surgery after the completed enrollment procedure. All patients and infusions were wormed to prevent unintended hypothermia. Induction of general anesthesia was with midazolam 2.5 mg, fentanyl 100 μg, propofol 1-2 mg/kg and vecuronium 0.1 mg/kg.

Balanced crystalloid fluids were used to treat hypovolemia. Additionally, 6% Hydroxyethyl starch was used before blood transfusion products to treat profound hypovolemia.

Blood transfusions were given according to clinical situation. Bradycardia was treated with atropine. Hypotension was treated with ephedrine boluses. Anti-inflammatory drug metamizole (dipyrone) 2.5 g was given intravenously before the end of the surgery and after 12 hours after the surgery. Neostigmine 2.5 mg with atropine 1 mg was used for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Participants were placed for one day in a urology high care unit provided with constant and vigilant nurse care.

Crystalloid infusions were used for maintaining diuresis. Gastroprotection was done with pantoprazole 40 mg. Metoclopramid 10 mg was given for postoperative nausea and vomiting (PONV).

The postoperative QoR was evaluated with three QoR scales. Scales for pain, anxiety and PONV were also examined. The 36-Item Short Form Survey (SF-36) questionnaire evaluated quality of life one month before and one month after surgery.

Enrollment

80 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Elective radical nephrectomy
American Society of Anesthesiologists (ASA) physical status classification system: I, II, III

Exclusion criteria

Dementia
Delirium
Acute psychosis
Emergent surgery
Hospitalisation in Intensive care unit
American Society of Anesthesiologists (ASA) physical status classification system: IV
Reoperations
Muscular diseases
Montreal cognitive test <24 points
Contraindications for epidural anesthesia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 2 patient groups

Epidural anesthesia and analgesia

Active Comparator group

Description:

Epidural catheter insertion: Th 9 - Th 10 or Th 10 - Th 11 using the midline approach. Safety of the epidural catheter was confirmed with lidocaine 60 mg. Epidural loading dose was given according to our classification (3,4,5 or 6 ml). Postoperative period in urology high care unit. Epidural analgesia ropivacaine/morphine was administered by a urologist according to our classification (2x2 ml, 2x3 ml and 3x3 ml).

Treatment: