This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicolas Arriaza Hinojosa, Universidad de Valparaiso
ClinicalTrials.gov Identifier:
NCT01833715
First received: March 30, 2013
Last updated: April 22, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Pain, Postoperative Drug: Morphine Drug: Methadone Drug: TIVA

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider
Primary Purpose: Treatment
Official Title: Efficacy Methadone for Management Postoperative Pain After the Use of Anesthesia Intravenous in Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by Nicolas Arriaza Hinojosa, Universidad de Valparaiso:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 86
Actual Study Start Date: March 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Morphine
morphine group 0.08 mg / kg, to start surgery
Drug: Morphine
Morphine group,receive morphine 0.08 mg / kg at the start of surgery
Drug: TIVA
TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.
Experimental: Methadone
methadone group 0.08 mg / kg, to start surgery
Drug: Methadone
Methadone group,receive methadone 0.08 mg / kg at the start of surgery
Drug: TIVA
TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01833715

Locations
Chile
Almirante Nef Naval Hospital
Viña del Mar, Valparaiso, Chile
Sponsors and Collaborators
Universidad de Valparaiso
Investigators
Principal Investigator: NICOLAS ARRIAZA, Physician University Valparaiso
  More Information

Responsible Party: Nicolas Arriaza Hinojosa, Physician, Universidad de Valparaiso
ClinicalTrials.gov Identifier: NCT01833715     History of Changes
Other Study ID Numbers: P03/13
Study First Received: March 30, 2013
Last Updated: April 22, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nicolas Arriaza Hinojosa, Universidad de Valparaiso:
Pain, Postoperative
Analgesics, Opioid
Methadone
Morphine

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Anesthetics
Morphine
Methadone
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Narcotics
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2017