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Methadone for Postoperative Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Morphine
Methadone
TIVA
Sponsored by
Universidad de Valparaiso
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring Pain, Postoperative, Analgesics, Opioid, Methadone, Morphine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Almirante Nef Naval Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morphine

Methadone

Arm Description

morphine group 0.08 mg / kg, to start surgery

methadone group 0.08 mg / kg, to start surgery

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Difference in pain scores, using the Numeric Rating Scale
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.

Full Information

First Posted
March 30, 2013
Last Updated
September 22, 2023
Sponsor
Universidad de Valparaiso
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1. Study Identification

Unique Protocol Identification Number
NCT01833715
Brief Title
Methadone for Postoperative Pain
Official Title
Efficacy Methadone for Management Postoperative Pain After the Use of Anesthesia Intravenous in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Valparaiso

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Pain, Postoperative, Analgesics, Opioid, Methadone, Morphine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Morphine
Arm Type
Active Comparator
Arm Description
morphine group 0.08 mg / kg, to start surgery
Arm Title
Methadone
Arm Type
Experimental
Arm Description
methadone group 0.08 mg / kg, to start surgery
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
Morphine group,receive morphine 0.08 mg / kg at the start of surgery
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
Methadone group,receive methadone 0.08 mg / kg at the start of surgery
Intervention Type
Drug
Intervention Name(s)
TIVA
Intervention Description
TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.
Primary Outcome Measure Information:
Title
Difference in milligrams of morphine used as rescue analgesia
Description
Difference in milligrams of morphine used as rescue analgesia in postoperative period in both groups
Time Frame
First 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Difference in pain scores, using the Numeric Rating Scale
Description
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.
Time Frame
First 24 hours postoperatively
Other Pre-specified Outcome Measures:
Title
The different of the adverse effect
Description
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.
Time Frame
First 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
NICOLAS ARRIAZA, Physician
Organizational Affiliation
University Valparaiso
Official's Role
Principal Investigator
Facility Information:
Facility Name
Almirante Nef Naval Hospital
City
Viña del Mar
State/Province
Valparaiso
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33905405
Citation
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.
Results Reference
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Methadone for Postoperative Pain

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