Morphine vs Sufentanil PCA: Same Same or Different?

NCT05259098 | Completed Phase 4 DMC

• 1 other identifier: 35/2019
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Post Operative Pain; Patient Satisfaction; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Adverse effects associated with analgesia

  Evaluation at 24 hours and 48 hours after surgery

• Total daily dose of opioid

  Evaluation at 24 hours and 48 hours after surgery

• Patients satisfaction with analgesia

  Evaluation at 24 hours and 48 hours after surgery

• Impact of the treatment on the quality of postoperative recovery

  Evaluation at 24 hours after surgery

• Incidence of postoperative chronic pain

  4 months after surgey

Study Arms (2)

Sufentanil Sublingual Tablet System

EXPERIMENTAL

Group treated with Sufentanil Sublingual Tablet System

Drug: Sufentanil Sublingual Tablet System

Intravenous Patient-Controlled Analgesia with Morphine

EXPERIMENTAL

Group treated with intravenous Patient-Controlled Analgesia with Morphine

Drug: Intravenous Patient-Controlled Analgesia with morfine

Interventions

Sufentanil Sublingual Tablet System 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.

Also known as: zalviso

Sufentanil Sublingual Tablet System

Intravenous Patient-Controlled Analgesia with morfine DRUG

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

Intravenous Patient-Controlled Analgesia with Morphine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Central do Funchal: lead

Study Sites (1)

Hospital Central do Funchal

Funchal, Madeira, 9000-177, Portugal

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative; Patient Satisfaction; Chronic Pain

Interventions

Sufentanil; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Analgesia; Anesthesia and Analgesia

Study Officials

• Ana IPG Pereira, Medical

  Hospital Central do Funchal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ana Isabel Freitas Amorim

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 28, 2022
• Study Start: October 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: October 31, 2020
• Last Updated: February 28, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

PT (1)