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Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

Primary Purpose

Post Operative Pain, Hyperalgesia

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ketamine infusion
Methadone PCA
Sponsored by
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring hyperalgesia, Patient controlled analgesia, morphine, methadone, ketamine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients undergoing open colo-rectal surgery

Exclusion Criteria:

  • ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.

Sites / Locations

  • Fondazione IRCCS Istituto Nazionale dei Tumori

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

zero/morphine

ketamine/morphine

zero/metadone

ketamine/methadone

Arm Description

Patient received a standard balance anaesthesia and morphine for post operative pain.

Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.

Methadone PCA

Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery. Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).

Outcomes

Primary Outcome Measures

the Extent of Hyperalgesia Area Proximal to Surgical Wound
Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three lines at a right angle to the top, middle, and bottom sides of the surgical incision. Each line starts from the edge of the abdomen to the surgical incision. Stimulation continue from the edge toward the surgical incision until the patients reported a worsening in sensation The distance from the incision to where sensation change was measured. The mean of the three assessments was used as a measure of the extent of the hyperalgesia area.

Secondary Outcome Measures

Pain Intensity Measured by a Numeric Rating Scale (NRS)
A Numerical Rating Scale (NRS) from 0 to 10 is used as a measure of pain intensity. Zero indicates the absence of any pain and 10 the worse pain never felt.
Opioid Consumption
Cumulative opioid consumption at 48 hours from surgery ( end of the study)

Full Information

First Posted
May 5, 2012
Last Updated
January 17, 2023
Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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1. Study Identification

Unique Protocol Identification Number
NCT01594047
Brief Title
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Official Title
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2009 (Actual)
Primary Completion Date
June 1, 2012 (Actual)
Study Completion Date
August 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.
Detailed Description
not desired

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain, Hyperalgesia
Keywords
hyperalgesia, Patient controlled analgesia, morphine, methadone, ketamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
zero/morphine
Arm Type
No Intervention
Arm Description
Patient received a standard balance anaesthesia and morphine for post operative pain.
Arm Title
ketamine/morphine
Arm Type
Experimental
Arm Description
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery.
Arm Title
zero/metadone
Arm Type
Experimental
Arm Description
Methadone PCA
Arm Title
ketamine/methadone
Arm Type
Experimental
Arm Description
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery. Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).
Intervention Type
Drug
Intervention Name(s)
ketamine infusion
Other Intervention Name(s)
hyperalgesia-blocker
Intervention Description
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery
Intervention Type
Drug
Intervention Name(s)
Methadone PCA
Other Intervention Name(s)
hyperalgesia-blocker
Intervention Description
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
Primary Outcome Measure Information:
Title
the Extent of Hyperalgesia Area Proximal to Surgical Wound
Description
Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three lines at a right angle to the top, middle, and bottom sides of the surgical incision. Each line starts from the edge of the abdomen to the surgical incision. Stimulation continue from the edge toward the surgical incision until the patients reported a worsening in sensation The distance from the incision to where sensation change was measured. The mean of the three assessments was used as a measure of the extent of the hyperalgesia area.
Time Frame
24 and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Pain Intensity Measured by a Numeric Rating Scale (NRS)
Description
A Numerical Rating Scale (NRS) from 0 to 10 is used as a measure of pain intensity. Zero indicates the absence of any pain and 10 the worse pain never felt.
Time Frame
24 and 48 hours after surgery
Title
Opioid Consumption
Description
Cumulative opioid consumption at 48 hours from surgery ( end of the study)
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients undergoing open colo-rectal surgery Exclusion Criteria: ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emiliano Tognoli
Organizational Affiliation
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondazione IRCCS Istituto Nazionale dei Tumori
City
Milano
ZIP/Postal Code
20133
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
32516227
Citation
Tognoli E, Proto PL, Motta G, Galeone C, Mariani L, Valenza F. Methadone for postoperative analgesia: contribution of N-methyl-D-aspartate receptor antagonism: A randomised controlled trial. Eur J Anaesthesiol. 2020 Oct;37(10):934-943. doi: 10.1097/EJA.0000000000001217.
Results Reference
derived

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Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

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