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

NCT04521556 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-09-30

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • University Hospital of Split

    lead OTHER

Principal Investigators

  • Ruben Kovac · University Hospital Split, Department of Anesthesiology and Intensive Care

  • Bozidar Duplancic · University Hospital Split, Department of Anesthesiology and Intensive Care

  • Verica Ilijev · University Hospital Split, Department of Anesthesiology and Intensive Care

  • Ivo Juginovic · University Hospital Split, Department of Urology

  • Ivan Velat · University Hospital Split,Department of Urology

  • Hrvoje Vucemilovic · University Hospital Split, Department of Anesthesiology and Intensive Care

  • Svjetlana Dosenovic · University Hospital Split, Department of Anesthesiology and Intensive Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2021-04-01
Completion
2021-06-01

Countries

  • Croatia

Study Locations

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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 NCT04521556 on ClinicalTrials.gov