Morphine vs Sufentanil PCA: Same Same or Different?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery

Conditions
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Patient Satisfaction, Chronic Pain, Analgesia, Post Operative Pain

Intervention / Treatment
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* Drug: Sufentanil Sublingual Tablet System
* Drug: Intravenous Patient-Controlled Analgesia with morfine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Informed consent signed; Age superior to 18 years; Physical status according to the American Society of Anesthesiology (ASA) 1-3; Scheduled gynecological surgery: abdominal hysterectomy Scheduled orthopedic surgery: total knee arthroplasty or total hip arthroplasty. Exclusion Criteria: Patient refusal to participate in the study; Age <18 years or legal dependence; Neurological or psychiatric pathology or altered state of consciousness that does not allow for the Patient Controlled Analgesia strategy; Documented drinking habits and/or consumption of illicit drugs; Patients tolerant to opioid therapy (use of >15 mg oral morphine or its equivalent per day for the last 3 months); Documented obstructive Sleep Apnea Syndrome (OSAS); Patients on long-term oxygen therapy; Intraoperative use of intrathecal morphine; Use of anesthetic techniques in order to provide postoperative analgesia (eg, epidural catheter; peripheral nerve block; infiltration of the surgical wound with local anesthetic).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil Sublingual Tablet System<br>Group treated with Sufentanil Sublingual Tablet System | Drug: Sufentanil Sublingual Tablet System<br>* 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.<br>* Other names: zalviso;|
| Experimental: Intravenous Patient-Controlled Analgesia with Morphine<br>Group treated with intravenous Patient-Controlled Analgesia with Morphine | Drug: Intravenous Patient-Controlled Analgesia with morfine<br>* Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain control | Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale | Evaluation at 24 hours and 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects associated with analgesia | 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 | Evaluation at 24 hours and 48 hours after surgery | 
| Total daily dose of opioid | Evaluation of total daily dose of each drug | Evaluation at 24 hours and 48 hours after surgery | 
| Patients satisfaction with analgesia | Evaluation of patient satisfaction using a qualitative scale: Poor; Average; Good; Excellent | Evaluation at 24 hours and 48 hours after surgery | 
| Impact of the treatment on the quality of postoperative recovery | Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire | Evaluation at 24 hours after surgery | 
| Incidence of postoperative chronic pain | Assessment to persistent postoperative pain by completing the Brief Pain Inventory | 4 months after surgey |