QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE

NCT03045133 | Completed Phase 4

• 1 other identifier: PUCSP 050539/2016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction. Despite the advantages associated with the use of remifentanil during total intravenous anesthesia (TIVA), it has been observed a frequent difficulty in the control of postoperative pain due to the risk of developing hyperalgesia and acute tolerance associated with the administration of this opioid. There is evidence that NMDA receptors are involved in the development of these changes. Methadone is an opioid that exhibits analgesic potency similar to that of morphine but has NMDA antagonist activity and longer duration of action as additional features. The objective of the study was to evaluate the quality of recovery (QoR40) of patients undergoing TIVA for laparoscopic cholecystectomy and who received morphine or methadone to control postoperative pain. Methods. Patients aged 18 to 65 years, physical status ASA I and II, submitted to total venous anesthesia (propofol and remifentanil) for laparoscopic cholecystectomy and eligible to participate in this prospective and randomized clinical study will be evaluated. After induction of anesthesia, patients will receive a solution containing 0.1 mg.kg-1 morphine (MF group) or 0.1 mg.kg-1 methadone (MT group). Data on the presence of pain, nausea, vomiting, tremor, drowsiness, presence of SpO2 \<92%, even with O2 face mask (5 L.min-1) and length of stay will be recorded at PACU. The pain will be evaluated every 15 minutes on a verbal numerical scale (ENV) from 0 to 10. E.v. morphine 0.1 mg.kg-1 (MF group) or methadone 0.1 mg.kg-1 (MT group) will be administered every 15 minutes to obtain the score below 3. After discharge from the PACU, all patients will receive intravenous ketoprofen every 12 hours and dipyrone every 6 hours. For cases where the patient considers the analgesic regimen insufficient, tramadol (100 mg) will be administered intravenously at 8-hour intervals. The consumption of analgesics, the intensity of pain, the occurrence of nausea, vomiting and other complications in the ward will be recorded. The application of the questionnaire (QoR40) will be performed in the ward the morning after the surgery by a medical student.

Conditions

Pain, Postoperative; Nausea and Vomiting, Postoperative

Keywords

Postoperative pain; Postoperative nausea and vomiting; Quality of recovery; QoR-40; Total intravenous anesthesia

Outcome Measures

Primary Outcomes (1)

• Quality of recovery (QoR-40)

  The baseline QoR-40 questionnaire will be provided to subjects after informed consent is obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator. The QoR-40 questionnaire assesses five dimensions of recovery (physical comfort - 12 items; emotional state - 7 items; physical independence - 5 items; physiological support - 7 items; and pain - 7 items). Each item is rated on a five-point Likert scale: none of the time, some of the time, usually, most of the time, and all the time. The total score on the QoR-40 ranges from 40 (poorest quality of recovery) to 200 (best quality of recovery).

  24 hours

Secondary Outcomes (6)

• Time to eye opening

  30 minutes

• Postoperative pain (PACU)

  2 hours

• Postoperative pain (Ward)

  24 hours

• Tramadol consumption

  24 hours

• Postoperative nausea and vomiting

  24 hours

Study Arms (2)

MT group

ACTIVE COMPARATOR

Immediately after the induction of anesthesia, patients will receive intravenously methadone 0.1 mg/kg

Drug: Methadone

MF group

ACTIVE COMPARATOR

Immediately after the induction of anesthesia, patients will receive intravenously morphine 0.1 mg/kg

Drug: Morphine

Interventions

Methadone DRUG

Immediately after the induction of anesthesia, patients will receive intravenously methadone 0.1 mg/kg

MT group

Morphine DRUG

Immediately after the induction of anesthesia, patients will receive intravenously morphine 0.1 mg/kg

MF group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status I or II, who will be scheduled to undergo laparoscopic cholecystectomy at Santa Lucinda Hospital

You may not qualify if:

• Patients who (i) refuse to participate in the study; (ii) are not able to communicate due to alterations in the level of consciousness, or neurologic, or psychiatric disease; - present with contraindication to any of the drugs used in the present study
• have history of alcohol or drug abuse
• present a body mass index (BMI) ≥ 40 will be excluded.

Sponsors & Collaborators

• Pontificia Universidade Catolica de Sao Paulo: lead

Study Sites (1)

Santa Lucinda Hospital

Sorocaba, São Paulo, 18030-230, Brazil

Location

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Methadone; Morphine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Eduardo T Moro, Professor

  PUC São Paulo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Group assignments were sealed in sequentially numbered opaque envelopes that were opened after patient inclusion in the study. All care providers, researchers, and patients were blinded to group assignments. Study 10-mL syringes will be prepared by an anesthesiologist independent of the study. Methadone 0.1 mg.kg-1 (made up to 10 mL with normal saline) or morphine 0.1 mg.kg-1 (made up to 10 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope is opened. The baseline QoR-40 questionnaire will be provided to subjects after informed consent is obtained in the preoperative holding area and 24 hours after surgery by a blinded investigator.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Prospective, randomized, double-blinded trial

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: June 20, 2016
• Primary Completion: July 20, 2016
• Study Completion: April 20, 2017
• Last Updated: May 8, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)