Efficacy of Intrathecal Morphine for Postoperative Analgesia with or without Suprainguinal Fascia Iliaca Block After Total Hip Arthroplasty: A Double-Blind Randomized Clinical Trial

Conditions

Total hip arthroplasty under spinal anesthesia

Brief summary

The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.

Detailed description

Total consumption of morphine equivalents during the first 48 hours post- operatively, through IV administration of morphine on a Patient Controlled Intravenous Analgesia (PCIA) device., NRS pain scores at rest and mobilization at fixed times: 8 hours after surgery, at 8:00 am, 1:00 pm and 6:00 pm on the first (D1) and second (D2) day after surgery (pain trajectory), Postoperative complications such as: orthostatic intolerance, falls and postoperative nausea and vomiting, Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness, Patient's pain related experience assessed by the International Pain Outcome (IPO) questionnaire at D2, Quality-of-Recovery 15-items (QoR-15) score for assessment of functional recovery on D1, D2, day-7 (D7) and day-30 (D30)

Related papers

No related papers found yet.

Interventions

DRUGMARCAINE 0

DRUG5 %

DRUGsolution injectable

DRUGLinisol 1 %

DRUGEtoricoxib AB 60 mg comprimés pelliculés

DRUGDafalgan Caps Forte 1 g harde capsules

DRUGAacidexam 5 mg/ml solution injectable

DRUGMINI-PLASCO NACL B. BRAUN 0

DRUG9 %

DRUGoplossing voor injectie

DRUGNAROPIN 7

DRUG5 mg/ml

DRUGMORPHINE HCl STEROP 10mg/1ml Solution injectable

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoints will be dynamic NRS pain (NRS 0 to 10) at passive 90- degree flexion of the lower limb on the trunk in the supine position at 8 hours after surgery.	—

Secondary

Measure	Time frame
Total consumption of morphine equivalents during the first 48 hours post- operatively, through IV administration of morphine on a Patient Controlled Intravenous Analgesia (PCIA) device., NRS pain scores at rest and mobilization at fixed times: 8 hours after surgery, at 8:00 am, 1:00 pm and 6:00 pm on the first (D1) and second (D2) day after surgery (pain trajectory), Postoperative complications such as: orthostatic intolerance, falls and postoperative nausea and vomiting, Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness, Patient's pain related experience assessed by the International Pain Outcome (IPO) questionnaire at D2, Quality-of-Recovery 15-items (QoR-15) score for assessment of functional recovery on D1, D2, day-7 (D7) and day-30 (D30)	—

Measure

Time frame

Total consumption of morphine equivalents during the first 48 hours post- operatively, through IV administration of morphine on a Patient Controlled Intravenous Analgesia (PCIA) device., NRS pain scores at rest and mobilization at fixed times: 8 hours after surgery, at 8:00 am, 1:00 pm and 6:00 pm on the first (D1) and second (D2) day after surgery (pain trajectory), Postoperative complications such as: orthostatic intolerance, falls and postoperative nausea and vomiting, Morphine-related side effects: bladder globe, constipation, dizziness and drowsiness, Patient's pain related experience assessed by the International Pain Outcome (IPO) questionnaire at D2, Quality-of-Recovery 15-items (QoR-15) score for assessment of functional recovery on D1, D2, day-7 (D7) and day-30 (D30)

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Countries

Belgium

Outcome results

None listed