Morphine vs Sufentanil PCA: Same Same or Different?

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Analgesia; Patient Satisfaction; Post Operative Pain
• Intervention / Treatment: Drug: Sufentanil Sublingual Tablet System; Drug: Intravenous Patient-Controlled Analgesia with morfine

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.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Madeira
    • Funchal, Madeira, Portugal, 9000-177
      • Hospital Central do Funchal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sufentanil Sublingual Tablet System; Group treated with Sufentanil Sublingual Tablet System	Drug: 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.; Other Names: zalviso
Experimental: Intravenous Patient-Controlled Analgesia with Morphine; Group treated with intravenous Patient-Controlled Analgesia with Morphine	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Central do Funchal
• Investigators: Principal Investigator: Ana IPG Pereira, Medical, Hospital Central do Funchal

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): October 31, 2020

Study Registration Dates

• First Submitted: February 7, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Sufentanil
• Other Study ID Numbers: 35/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No