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

NCT ID: NCT04521556

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-01
• Study Completion Date: 2021-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Epidural anesthesia and analgesia

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).

Group Type: ACTIVE_COMPARATOR

Epidural anesthesia with light general anesthesia

Intervention Type: PROCEDURE

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.

Postoperative epidural analgesia

Intervention Type: PROCEDURE

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.

Balanced general anesthesia and tramadol analgesia

Postoperative period in urology high care unit.

Group Type: ACTIVE_COMPARATOR

General anesthesia

Intervention Type: PROCEDURE

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.

Continuous intravenous analgesia

Intervention Type: DRUG

Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Continuous intravenous analgesia

Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.

Intervention Type: DRUG

Other Intervention Names

Epidural analgesia with morphine and ropivacaine; Continuous tramadol analgesia

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Split

OTHER

Sponsor Role: lead

Responsible Party

Ruben Kovac

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruben Kovac

Role: PRINCIPAL_INVESTIGATOR

University Hospital Split, Department of Anesthesiology and Intensive Care

Bozidar Duplancic

Role: STUDY_DIRECTOR

University Hospital Split, Department of Anesthesiology and Intensive Care

Verica Ilijev

Role: STUDY_CHAIR

University Hospital Split, Department of Anesthesiology and Intensive Care

Ivo Juginovic

Role: STUDY_CHAIR

University Hospital Split, Department of Urology

Ivan Velat

Role: STUDY_CHAIR

University Hospital Split,Department of Urology

Hrvoje Vucemilovic

Role: STUDY_CHAIR

University Hospital Split, Department of Anesthesiology and Intensive Care

Svjetlana Dosenovic

Role: STUDY_CHAIR

University Hospital Split, Department of Anesthesiology and Intensive Care

Locations

University Hospital Split

Split, , Croatia

Countries

Croatia

References

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Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id