N/A
Completed N=113
Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Post Operative Pain · Hyperalgesia
Source: ClinicalTrials.gov NCT01594047 ↗
Enrolled (actual)
113
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: the Extent of Hyperalgesia Area Proximal to Surgical Wound — 19.5; 14.68; 15.28; 11.04 cm
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the Extent of Hyperalgesia Area Proximal to Surgical Wound |
19.5; 14.68; 15.28; 11.04; 16.04; 16.38 | — |
| SECONDARY Pain Intensity Measured by a Numeric Rating Scale (NRS) |
1.92; 1.64; 0.61; 0.78; 4.75; 4.68 | — |
| SECONDARY Opioid Consumption |
56.09; 66.9; 43.64; 38.96 | — |
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.
Data sourced from ClinicalTrials.gov (NCT01594047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.