NCT04521556

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

Is Postoperative Quality of Recovery After Unilateral Nephrectomy Related to the Type of Anesthesia and Analgesia?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: University Hospital of Split · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Anesthesia
• Anesthesia Recovery Period
• Nephrectomy
• Patient Satisfaction
• Postoperative Period
• Quality of Life
• Analgesia
• Epidural

Interventions

Type	Name	Description
PROCEDURE	Epidural anesthesia with light general anesthesia	Epidural anaesthesia: mixture of ropivacaine 6.5 mg/ml and fentanyl 8.3 μg/ml. Light general anesthesia: isoflurane in mixture of 50/50 of nitrous oxide and oxygen to achieve Minimum alveolar concentration between 0.6 and 0.8.
PROCEDURE	Postoperative epidural analgesia	Before the end of operation was given 4 ml of the mixture of ropivacaine 4.4 mg/ml and morphine 0.8mg/ml. Epidural analgesia was continued for next 24 hours with a mixture of ropivacaine 2.2 mg/ml and morphine 0.4 mg/ml.
PROCEDURE	General anesthesia	Maintaining general anesthesia: nitrous oxide and oxygen in mixture 50/50 and isoflurane to achieve minimum alveolar concentration between 0.8 and 1. Fentanyl loading dose: 6-8 μg/kg. Additional fentanyl doses were given incrementally.
DRUG	Continuous intravenous analgesia	Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.

Timeline

• Start date: 2019-04-01
• Primary completion: 2021-04-01
• Completion: 2021-06-01
• First posted: 2020-08-20
• Last updated: 2021-09-30

Locations

1 site across 1 country: Croatia