Effect of Epidural Anesthesia and Analgesia on Quality of Recovery After Radical Prostatectomy.

Summary

Postoperative quality of recovery (QoR) could be related to anesthesia and postoperative analgesia. This study is exploring early QoR after radical prostatectomy in the two groups of anesthesia. The first group had a light general anesthesia with lumbal 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
• Radical Prostatectomy
• Patient Satisfaction
• Postoperative Period
• Quality of Life
• Analgesia
• Epidural
• Quality of Recovery

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.

DRUG

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, Split, Croatia

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

• Ivo Juginovic · University Hospital Split, Department of Urology

• Ivan Velat · University Hospital Center Split, Department of Urology, Split, Croatia

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

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2021-04-01

Completion

2021-06-01

Countries

• Croatia

Study Locations