Clinical trial NCT05259098: Morphine vs Sufentanil PCA: Same Same or Different?
Official title: "Sufentanil Sublingual Tablet System vs Intravenous Patient-Controlled Analgesia With Morphine: Postoperative Pain Control and Its Impact in Quality of Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Analgesia
Post Operative Pain
Patient Satisfaction
Chronic Pain
Lead sponsor: Hospital Central do Funchal
Sponsor class: OTHER
First posted: 2022-02-28
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Postoperative pain control
timeFrame: Evaluation at 24 hours and 48 hours after surgery
Secondary outcomes:
measure: Adverse effects associated with analgesia
timeFrame: Evaluation at 24 hours and 48 hours after surgery
measure: Total daily dose of opioid
timeFrame: Evaluation at 24 hours and 48 hours after surgery
measure: Patients satisfaction with analgesia
timeFrame: Evaluation at 24 hours and 48 hours after surgery
measure: Impact of the treatment on the quality of postoperative recovery
timeFrame: Evaluation at 24 hours after surgery
measure: Incidence of postoperative chronic pain
timeFrame: 4 months after surgey
Other outcomes:
Locations:
city: Funchal
country: Portugal
facility: Hospital Central do Funchal
state: Madeira
Study officials:
affiliation: Hospital Central do Funchal
name: Ana IPG Pereira, Medical
role: PRINCIPAL_INVESTIGATOR
References: