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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01594047
• Other study ID #: metadone
• Status: Completed
• Phase: N/A
• Start date: December 1, 2009
• Est. completion date: August 1, 2014

Study information

• Verified date: January 2023
• Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

not desired

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: August 1, 2014
• Est. primary completion date: June 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hyperalgesia
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• ketamine infusion
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
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)

Locations

Country	Name	City	State
Italy	Fondazione IRCCS Istituto Nazionale dei Tumori	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24 and 48 hours after surgery
Secondary	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.	24 and 48 hours after surgery
Secondary	Opioid Consumption	Cumulative opioid consumption at 48 hours from surgery ( end of the study)	48 hours