Hospital Central do Funchal
Funchal, Madeira, 9000-177, Portugal
NCT Number: NCT05259098
Patient-controlled intravenous analgesia (PCA) has already proven its quality. However, with new strategies starting to emerge and the current concept of opioid sparing, it is a goal to find the optimal PCA strategy capable of improve patient satisfaction and, at the same time, individualize opioid dose.
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System with intravenous PCA Morphine in terms of postoperative pain control satisfaction, total dose of opioid required, adverse effects, impact on the quality of postoperative recovery and the incidence of postoperative chronic pain.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Funchal, Madeira, 9000-177, Portugal
In a prospected randomized study, it was compared the use of Sufentanil Sublingual PCA System (15mcg per tablet, 20 minutes lockout) with intravenous PCA Morphine based on 1mg morphine on-demand 10 minutes lockout and a baseline perfusion of 1mg/hour.
45 patients capable of comply a PCA regime submitted to total knee arthroplasty, total hip arthroplasty and abdominal hysterectomy were enrolled in the study. During the first 48 hours, it was accessed daily pain scores, PCA use, need for rescue therapy, adverse effects, global satisfaction as well as postoperative quality recovery. Brief Pain Inventory was performed before surgery and 4 months later.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sufentanil Sublingual Tablet System is a sublingual opioid patient controlled analgesia system. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
Other names: zalviso
Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
Time frame: Evaluation at 24 hours and 48 hours after surgery
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale
Time frame: Evaluation at 24 hours and 48 hours after surgery
Evaluation of adverse effects of the PCA systems: sedation using the Richamond Agitation Sedation Scale (RASS); hypoxemia without oxygen supplementation: mild to moderate (SpO2 90-93%) or severe (SpO2<90%); hypotension; nausea or vomiting; dyspepsia; itching
Time frame: Evaluation at 24 hours and 48 hours after surgery
Evaluation of total daily dose of each drug
Time frame: Evaluation at 24 hours and 48 hours after surgery
Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent"
Time frame: Evaluation at 24 hours after surgery
Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire
Time frame: 4 months after surgey
Assessment to persistent postoperative pain by completing the Brief Pain Inventory
Hospital Central do Funchal
Other
"Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery
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