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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zero/morphine | No Intervention | Patient received a standard balance anaesthesia and morphine for post operative pain. | |
| ketamine/morphine | Experimental | 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. |
|
| zero/metadone | Experimental | Methadone PCA |
|
| ketamine/methadone | Experimental | 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.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ketamine infusion | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emiliano Tognoli | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | 20133 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32516227 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zero/Morphine | Patient received a standard balance anaesthesia and morphine for post operative pain. |
| FG001 | Ketamine/Morphine | 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. 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 |
| FG002 | Zero/Metadone | Methadone PCA Methadone PCA: Methadone administered by a PCA system (dose 2 mg, lock-out 12min.) |
| FG003 | Ketamine/Methadone | 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.). 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.) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zero/Morphine | Patient received a standard balance anaesthesia and morphine for post operative pain. |
| BG001 | Ketamine/Morphine | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | cm | 24 and 48 hours after surgery |
|
For each patient, adverse event data were collected up to 48 hours from surgery ( end of the study)
An adverse event is defined accordingly with the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zero/Morphine | Patient received a standard balance anaesthesia and morphine for post operative pain. |
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We chose to analyse mechanical static punctuate hyperalgesia along three lines lateral to the surgical wound, as it is the most common test used to characterise the effect of ketamine and others NMDAr blockers on neuroplasticity in surgical patients. We are aware that there is increasing evidence that the quantitative sensory testing may be more effective and specific in detecting and defining hyperalgesia, both in acute and chronic settings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tognoli Emiliano MD | Fondazione IRCCS Istituto nazionale dei Tumori | +39 0223902282 | Emiliano.Tognoli@istitutotumori.mi.it |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D006930 | Hyperalgesia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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|
| Methadone PCA | Drug | Methadone administered by a PCA system (dose 2 mg, lock-out 12min.) |
|
|
Cumulative opioid consumption at 48 hours from surgery ( end of the study) |
| 48 hours |
| BG002 | Zero/Metadone | Methadone PCA Methadone PCA: Methadone administered by a PCA system (dose 2 mg, lock-out 12min.) |
| BG003 | Ketamine/Methadone | 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.). 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.) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
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. 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 |
| OG002 | Zero/Metadone | Methadone PCA Methadone PCA: Methadone administered by a PCA system (dose 2 mg, lock-out 12min.) |
| OG003 | Ketamine/Methadone | 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.). 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.) |
|
|
| 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. | We performed a Dunn multiple comparison test for specific comparisons to assess group differences compared with the control group (0-Mo). Notably, the interaction term allowed us to test whether the effect of the two drugs, when jointly administered, was additive (lack of interaction) or more/ less than additive (presence of interaction). Data at 24 and 48 h were analyzed separately. | Posted | Mean | Standard Deviation | units on NRS | 24 and 48 hours after surgery |
|
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| Secondary | Opioid Consumption | Cumulative opioid consumption at 48 hours from surgery ( end of the study) | Posted | Mean | Standard Deviation | mg | 48 hours |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Ketamine/Morphine | 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. 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 | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | Zero/Metadone | Methadone PCA Methadone PCA: Methadone administered by a PCA system (dose 2 mg, lock-out 12min.) | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | Ketamine/Methadone | 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.). 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.) | 0 | 25 | 0 | 25 | 0 | 25 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D020886 | Somatosensory Disorders |
| D012678 | Sensation Disorders |
| D009422 | Nervous System Diseases |
| NRS dynamic 24 hours |
|
| NRS static 48 hours |
|
| NRS dynamic 48 hours |
|