Methadone for Postoperative Pain

NCT ID: NCT01833715

Last Updated: 2023-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Morphine

morphine group 0.08 mg / kg, to start surgery

Group Type: ACTIVE_COMPARATOR

Morphine

Intervention Type: DRUG

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

TIVA

Intervention Type: DRUG

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

Methadone

methadone group 0.08 mg / kg, to start surgery

Group Type: EXPERIMENTAL

Methadone

Intervention Type: DRUG

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

TIVA

Intervention Type: DRUG

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

Interventions

Morphine

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

Intervention Type: DRUG

Methadone

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

Intervention Type: DRUG

TIVA

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Valparaiso

OTHER

Sponsor Role: lead

Responsible Party

Eva Madrid

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NICOLAS ARRIAZA, Physician

Role: PRINCIPAL_INVESTIGATOR

University Valparaiso

Locations

Almirante Nef Naval Hospital

Viña del Mar, Región de Valparaíso, Chile

Countries

Chile

References

Arriaza N, Papuzinski C, Kirmayr M, Matta M, Aranda F, Stojanova J, Madrid E. Efficacy of methadone for the management of postoperative pain in laparoscopic cholecystectomy: A randomized clinical trial. Medwave. 2021 Mar 23;21(2):e8135. doi: 10.5867/medwave.2021.02.8134. English, Spanish.

Reference Type: BACKGROUND

PMID: 33905405 (View on PubMed)

Other Identifiers

P03/13

Identifier Type: -

Identifier Source: org_study_id