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Completed

NCT Number: NCT01833715

Methadone for Postoperative Pain

The aim of this study is to compare the efficacy of methadone versus morphine in dealing with postoperative pain, in laparoscopic cholecystectomy under total intravenous anesthesia (TIVA); Efficacy is defined in terms of the difference of milligrams in morphine used as rescue analgesia postoperatively. Our hypothesis is that methadone is more effective than morphine for postoperative pain treatment.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almirante Nef Naval Hospital

Viña del Mar, Valparaiso, Chile

About this study

Patients undergo laparoscopic cholecystectomy at Almirante Nef Naval Hospital will be recruited, between March and July 2013. The sample size was calculated to obtain an average difference of 4 mg of morphine (DE 1.5) to 3 mg of morphine (DE 1.5), with a power of 80% and a significance level of 0.05. This came down to 36 randomized patients into each group, so 86 patients will be recruited considering a 15% loss to follow up.

Before signing an informed consent, we will explain to them how to classify pain intensity numerical rating scale (NRS) and this will be evaluated periodically during the first 24 hours after surgery.

General anesthesia will be based on Remifentanil and Propofol, titrated to achieve bispectral index (BIS) between 40 and 60. Patients will be randomized into methadone group (ME) and morphine group (MO), they will receive 0.08 mg / kg bolus of methadone or 0.08 mg / kg bolus of morphine as applicable at the time of beginning surgery. Postoperative analgesia will be standard for both groups. Patient´s demographic data will be filed as well as surgical timings.

All patients will remain in the anesthetic recovery room for the first two hours , to get a record taken of vital signs and measurement of NRS at 5, 15, 30, 60 and 120 minutes. If NRS is greater than or equal to 4, 1 mg of morphine ev will be used as analgesic rescue. In room measuring NRS continue hospitalized at 4, 8, 12 and 24 hours postoperatively and were used as rescue analgesia if ketorolac 30mg ev NRS is greater than or equal to 4. The amount of morphine is registered and ketorolac rescue of both groups as well as pain assessment scores. The occurrence of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is also recorded in both groups, to be compared later as a secondary objective.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing laparoscopic cholecystectomy in the Almirante Nef Naval Hospital
  • Patients ASA 1 or 2

Exclusion criteria

  • Patients with renal insufficiency (creatinine> 2.0 mg / dl)
  • Patients with a history of liver failure
  • Patients with BMI> 35 kg/m2
  • Patients with hypersensitivity to the drugs in question
  • History of chronic use of opioids
  • Need for conversion to open surgery

Treatment and study plan

Morphine

Drug

Morphine group,receive morphine 0.08 mg / kg at the start of surgery

Methadone

Drug

Methadone group,receive methadone 0.08 mg / kg at the start of surgery

TIVA

Drug

TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.

Primary outcomes

  1. Difference in milligrams of morphine used as rescue analgesia

    Time frame: First 24 hours postoperatively

    Difference in milligrams of morphine used as rescue analgesia in postoperative period in both groups

Secondary outcomes

  1. Difference in pain scores, using the Numeric Rating Scale

    Time frame: First 24 hours postoperatively

    Difference in pain scores, using the Numeric Rating Scale at 5, 15, 30, 60 and 120 minutes postoperative. Also at 4, 8, 12 and 24 hours postoperatively, during hospitalization.

Other outcomes

  1. The different of the adverse effect

    Time frame: First 24 hours postoperatively

    The total number of adverse effects such as nausea, vomiting, pruritus, urinary retention and respiratory depression is recorded in both groups, to be compared later as a secondary objective.

Sponsors and collaborators

Lead sponsor

Universidad de Valparaiso

Other

Registry information

Official study title

Efficacy Methadone for Management Postoperative Pain After the Use of Anesthesia Intravenous in Laparoscopic Cholecystectomy

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2013
Registry last updated
Sep 26, 2023

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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