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

September 28, 2021 updated by: Ruben Kovac, University Hospital of Split

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Split, Croatia, 21000
        • University Hospital Split

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 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).
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.
Other Names:
  • Epidural analgesia with morphine and ropivacaine
ACTIVE_COMPARATOR: Balanced general anesthesia and tramadol analgesia
Postoperative period in urology high care unit.
Drug: Continuous intravenous analgesia
Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.
Other Names:
  • Continuous tramadol analgesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of recovery 40 (QoR-40)
Time Frame: 24 hours after surgery
The QoR-40 measures five related dimensions of quality of recovery: emotional state (8 items), physical comfort (12 items), physical independence (5 items), psychological support (7 items) and pain (7 items). Each item is rated on a 5 point Likert scale. Minimal possible score is 40 and maximal possible score is 200.
24 hours after surgery
Quality of recovery 15 (QoR-15)
Time Frame: 24 hours after surgery
Quality of recovery (QoR-15) is a short version of QoR - 40 questionnaire. The QoR-15 questionnaire has 15 items scaled from 0 to 10. Minimum score is 0, and maximum 150. It is shorter, user friendly and less time consuming then extensive QoR-40 questionnaire.
24 hours after surgery
Visual analog scale of quality of recovery (QoR)
Time Frame: 24 hours after surgery
Patient rated visual analog scale is a simple scale for rating the quality of recovery by placing "X" on the line. Poor recovery is on the left side of the line. Under the end of the left line is an explanation of poor recovery: in severe pain, nausea & vomiting, confused, immobilized, unable to eat and unable to communicate. Excellent recovery is on the right side of the line. Under the end of the line is a written explanation: without any pain, comfortable, alert, active, enjoying food and communicating freely.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Simplified postoperative nausea and vomiting (PONV) impact scale
Time Frame: 24 hours after surgery
PONV impact scale consists of 2 questions that are scored from 0 to 3. Five points or six defines clinically important PONV.
24 hours after surgery
Visual analog scale of pain- at rest and during coughing and straining
Time Frame: 24 hours after surgery
Patient rated visual analog pain scale is a simple scale for rating the quality of recovery by placing "X" on the line. No pain at all is written on the left side of the line. The worst possible pain is on the right side of the line.
24 hours after surgery
Numerical pain scale - at rest and during coughing and straining
Time Frame: 24 hours after surgery
Similar to the visual analog scale of pain, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling pain in numbers (0-10) is more clear than analog scale.
24 hours after surgery
Visual pain scale with faces- at rest and during coughing and straining
Time Frame: 24 hours after surgery
Similar to the numeric pain scale. If pain scaling in numbers is vaguely, then six faces with emotional expression ranging from a happy smiling to a crying face with tears explain numbers under the faces (0,2,4,6,8,10).
24 hours after surgery
Visual analog scale of anxiety
Time Frame: 24 hours after surgery
Patient rated visual analog scale is a simple scale for rating the level of anxiety by placing "X" on the line. No anxiety at all is written on the left side of the line. The worst possible anxiety is on the right side of the line.
24 hours after surgery
Numerical anxiety scale
Time Frame: 24 hours after surgery
Similar to the visual analog scale of anxiety, but instead of line, it consists of a sequence of numbers (0-10). For some participants, scaling in numbers (0-10) is more clear than analog scale.
24 hours after surgery
Visual anxiety scale with faces
Time Frame: 24 hours after surgery
Similar to the numerical anxiety scale. For some patients quantifying pain in numbers is vague, but if they can observe faces with different emotional expressions ranging from a happy smiling to a crying face with tears. Under the faces are written corresponding numbers (0,2,4,6,8,10)
24 hours after surgery
The short form health survey version one (SF-36:I)
Time Frame: 24 hours after surgery and one month after surgery
The short form health survey version one (SF-36:I.) measure eight dimensions of quality of life: physical functioning (10 items), role limitation due to physical problems (4 items), bodily pain (2 items), social functioning (2 items), mental health (5 items), role limitation due to emotional problems (3 items), vitality (4 items) and general health perception (5 items). Each dimension has a possible score of 0 (poor health) to 100 (excellent health).
24 hours after surgery and one month after surgery
Global visual analog and numeric scale of nausea intensity
Time Frame: 24 hours after surgery
Scale for rating the nausea intensity by placing "X" on the line. No nausea at all is written on the left side of the line. The worst possible nausea experienced is on the right side of the line. Under the line are written numbers (0-10).
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital of Split

Investigators

  • Principal Investigator: Ruben Kovac, University Hospital Split, Department of Anesthesiology and Intensive Care
  • Study Director: Bozidar Duplancic, University Hospital Split, Department of Anesthesiology and Intensive Care
  • Study Chair: Verica Ilijev, University Hospital Split, Department of Anesthesiology and Intensive Care
  • Study Chair: Ivan Velat, University Hospital Split,Department of Urology
  • Study Chair: Hrvoje Vucemilovic, University Hospital Split, Department of Anesthesiology and Intensive Care
  • Study Chair: Svjetlana Dosenovic, University Hospital Split, Department of Anesthesiology and Intensive Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2019

Primary Completion (ACTUAL)

April 1, 2021

Study Completion (ACTUAL)

June 1, 2021

Study Registration Dates

First Submitted

August 12, 2020

First Submitted That Met QC Criteria

August 16, 2020

First Posted (ACTUAL)

August 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 30, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2181-147-01/06/M.S.-19-2.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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