NCT01833715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 17, 2013

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

March 30, 2013

Last Update Submit

September 22, 2023

Conditions

Pain, Postoperative

Keywords

Pain, PostoperativeAnalgesics, OpioidMethadoneMorphine

Outcome Measures

Primary Outcomes (1)

  • Difference in milligrams of morphine used as rescue analgesia

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

    First 24 hours postoperatively

Secondary Outcomes (1)

  • Difference in pain scores, using the Numeric Rating Scale

    First 24 hours postoperatively

Other Outcomes (1)

  • The different of the adverse effect

    First 24 hours postoperatively

Study Arms (2)

Morphine

ACTIVE COMPARATOR

morphine group 0.08 mg / kg, to start surgery

Drug: MorphineDrug: TIVA

Methadone

EXPERIMENTAL

methadone group 0.08 mg / kg, to start surgery

Drug: MethadoneDrug: TIVA

Interventions

MorphineDRUG

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

Morphine
MethadoneDRUG

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

Methadone
TIVADRUG

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

MethadoneMorphine

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Almirante Nef Naval Hospital

Viña del Mar, Región de Valparaíso, Chile

Location

Related Publications (1)

  • 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.

    PMID: 33905405BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

MorphineMethadone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsKetonesOrganic Chemicals

Study Officials

  • NICOLAS ARRIAZA, Physician

    University Valparaiso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 30, 2013

First Posted

April 17, 2013

Study Start

March 1, 2013

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

September 26, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)