TRAMORNOT: Tramadol versus morphine in postoperative analgesia after laparoscopic abdominal surgery: a randomized controlled trial

Conditions

Postoperative pain following scheduled major laparoscopic abdominal surgery

Brief summary

The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.

Detailed description

QoR-15 questionnaire scores at 48 and 72 hours, Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours, Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively, Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration, Length of stay in the PACU (minutes) and total postoperative hospital stay (days), Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool), Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge, Number of patients consuming opioids daily at 1 and 3 months post-discharge, Misuse risk assessment using the POMI-5F scale, Presence of chronic post-surgical pain at 3 months after surgery

Related papers

No related papers found yet.

Interventions

DRUGMorphine Sulfate 10mg /ml Solution for Injection

DRUGMorfinesulfaat Sandoz 10 mg

DRUGtabletten

DRUGTramadol 100 mg/ml oral drops

DRUGsolution.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is the multidimensional score validated in French assessing postoperative patient recovery: the QoR-15 (Quality of Recovery-15) score at 24 hours after surgery.	—

Secondary

Measure	Time frame
QoR-15 questionnaire scores at 48 and 72 hours, Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours, Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively, Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration, Length of stay in the PACU (minutes) and total postoperative hospital stay (days), Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool), Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge, Number of patients consuming opioids daily at 1 and 3 months post-discharge, Misuse risk assessment using the POMI-5F scale, Presence of chronic post-surgical pain at 3 months after surgery	—

Measure

Time frame

QoR-15 questionnaire scores at 48 and 72 hours, Mean postoperative pain NRS (0–10) scores in the Post-Anesthesia Care Unit (PACU), and at 24, 48, and 72 hours, Opioid consumption expressed in oral morphine equivalent at 24 and 72 hours postoperatively, Analgesic efficacy after opioid administration, assessed by NRS (0–10) two hours post opioid administration, Length of stay in the PACU (minutes) and total postoperative hospital stay (days), Occurrence of the following adverse effects after opioid use: nausea/vomiting, ileus, hypoxemia, pruritus, confusion (assessed by CAM tool), Pain management satisfaction score, evaluated on a numerical scale from 0 to 10 (0 = total dissatisfaction, 10 = total satisfaction) at hospital discharge, Number of patients consuming opioids daily at 1 and 3 months post-discharge, Misuse risk assessment using the POMI-5F scale, Presence of chronic post-surgical pain at 3 months after surgery

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Countries

France

Outcome results

None listed