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Completed

NCT Number: NCT04521556

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

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.

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Key information

Conditions

Anesthesia Agnosia Analgesia Anesthesia Recovery Period Behavior Epidural Health Behavior Nephrectomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Patient Satisfaction Perceptual Disorders Postoperative Period Quality of Life Signs and Symptoms Treatment Adherence and Compliance

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Split

Split, 21000, Croatia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural anesthesia with light general anesthesia

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

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.

Other names: Epidural analgesia with morphine and ropivacaine

General Anesthesia

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

Drug

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

Other names: Continuous tramadol analgesia

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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)

  7. 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).

  8. 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.

  9. 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).

Sponsors and collaborators

Lead sponsor

University Hospital of Split

Other

Registry information

Official study title

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

Acronym: QoR

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Aug 20, 2020
Registry last updated
Sep 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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