NCT03045133

QUALITY OF RECOVERY AFTER INTRAOPERATIVE MORPHINE OR METHADONE

Completed Phase 4 Last updated 8 May 2017

What this trial tests

Phase 4 trial testing Methadone in Pain, Postoperative in 70 participants. Completed in 20 April 2017.

Timeline

20 June 2016

Primary endpoint
20 July 2016

20 April 2017

Quick facts

Lead sponsor	Pontificia Universidade Catolica de Sao Paulo
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	70
Start date	20 June 2016
Primary completion	20 July 2016
Estimated completion	20 April 2017
Sites	1 location across Brazil

Drugs / interventions tested

• Methadone (METHADONE) — full drug profile →
• Morphine

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Nausea and Vomiting, Postoperative — all drugs for Nausea and Vomiting, Postoperative →

Sponsor

Pontificia Universidade Catolica de Sao Paulo — full company profile →

Who can join

Adults 18 to 65, any sex, with Pain, Postoperative or Nausea and Vomiting, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.