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Completed

NCT Number: NCT05259098

Morphine vs Sufentanil PCA: Same Same or Different?

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Other names: zalviso

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.

Primary outcomes

  1. Postoperative pain control

    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

Secondary outcomes

  1. Adverse effects associated with analgesia

    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

  2. Total daily dose of opioid

    Time frame: Evaluation at 24 hours and 48 hours after surgery

    Evaluation of total daily dose of each drug

  3. Patients satisfaction with analgesia

    Time frame: Evaluation at 24 hours and 48 hours after surgery

    Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent"

  4. Impact of the treatment on the quality of postoperative recovery

    Time frame: Evaluation at 24 hours after surgery

    Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire

  5. Incidence of postoperative chronic pain

    Time frame: 4 months after surgey

    Assessment to persistent postoperative pain by completing the Brief Pain Inventory

Sponsors and collaborators

Lead sponsor

Hospital Central do Funchal

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2022
Registry last updated
Feb 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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