Morphine vs Sufentanil PCA: Same Same or Different?

NCT ID: NCT05259098

Last Updated: 2022-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-10-31

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.

Conditions

Analgesia; Post Operative Pain; Patient Satisfaction; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sufentanil Sublingual Tablet System

Group treated with Sufentanil Sublingual Tablet System

Group Type: EXPERIMENTAL

Sufentanil Sublingual Tablet System

Intervention Type: DRUG

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.

Intravenous Patient-Controlled Analgesia with Morphine

Group treated with intravenous Patient-Controlled Analgesia with Morphine

Group Type: EXPERIMENTAL

Intravenous Patient-Controlled Analgesia with morfine

Intervention Type: DRUG

Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.

Interventions

Sufentanil Sublingual Tablet System

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.

Intervention Type: DRUG

Intravenous Patient-Controlled Analgesia with morfine

Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.

Intervention Type: DRUG

Other Intervention Names

zalviso

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Central do Funchal

OTHER

Sponsor Role: lead

Responsible Party

Ana isabel freitas amorim

Ana Isabel Freitas Amorim

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana IPG Pereira, Medical

Role: PRINCIPAL_INVESTIGATOR

Hospital Central do Funchal

Locations

Hospital Central do Funchal

Funchal, Madeira, Portugal

Countries

Portugal

Other Identifiers

35/2019

Identifier Type: -

Identifier Source: org_study_id