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Morphine vs Sufentanil PCA: Same Same or Different?

Primary Purpose

Analgesia, Post Operative Pain, Patient Satisfaction

Status
Completed
Phase
Phase 4
Locations
Portugal
Study Type
Interventional
Intervention
Sufentanil Sublingual Tablet System
Intravenous Patient-Controlled Analgesia with morfine
Sponsored by
Hospital Central do Funchal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Hospital Central do Funchal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sufentanil Sublingual Tablet System

Intravenous Patient-Controlled Analgesia with Morphine

Arm Description

Group treated with Sufentanil Sublingual Tablet System

Group treated with intravenous Patient-Controlled Analgesia with Morphine

Outcomes

Primary Outcome Measures

Postoperative pain control
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale

Secondary Outcome Measures

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
Total daily dose of opioid
Evaluation of total daily dose of each drug
Patients satisfaction with analgesia
Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent"
Impact of the treatment on the quality of postoperative recovery
Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire
Incidence of postoperative chronic pain
Assessment to persistent postoperative pain by completing the Brief Pain Inventory

Full Information

First Posted
February 7, 2022
Last Updated
February 18, 2022
Sponsor
Hospital Central do Funchal
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1. Study Identification

Unique Protocol Identification Number
NCT05259098
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Central do Funchal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia, Post Operative Pain, Patient Satisfaction, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sufentanil Sublingual Tablet System
Arm Type
Experimental
Arm Description
Group treated with Sufentanil Sublingual Tablet System
Arm Title
Intravenous Patient-Controlled Analgesia with Morphine
Arm Type
Experimental
Arm Description
Group treated with intravenous Patient-Controlled Analgesia with Morphine
Intervention Type
Drug
Intervention Name(s)
Sufentanil Sublingual Tablet System
Other Intervention Name(s)
zalviso
Intervention Description
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
Intervention Name(s)
Intravenous Patient-Controlled Analgesia with morfine
Intervention Description
Intravenous Patient-Controlled Analgesia with morfine. It was used for postoperative analgesia after surgery associated with moderate to severe pain.
Primary Outcome Measure Information:
Title
Postoperative pain control
Description
Comparison between patient controlled analgesia with IV morphine and sublingual sufentanil in Numeric Rating Scale
Time Frame
Evaluation at 24 hours and 48 hours after surgery
Secondary Outcome Measure Information:
Title
Adverse effects associated with analgesia
Description
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
Time Frame
Evaluation at 24 hours and 48 hours after surgery
Title
Total daily dose of opioid
Description
Evaluation of total daily dose of each drug
Time Frame
Evaluation at 24 hours and 48 hours after surgery
Title
Patients satisfaction with analgesia
Description
Evaluation of patient satisfaction using a qualitative scale: "Poor"; "Average"; "Good"; "Excellent"
Time Frame
Evaluation at 24 hours and 48 hours after surgery
Title
Impact of the treatment on the quality of postoperative recovery
Description
Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire
Time Frame
Evaluation at 24 hours after surgery
Title
Incidence of postoperative chronic pain
Description
Assessment to persistent postoperative pain by completing the Brief Pain Inventory
Time Frame
4 months after surgey

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana IPG Pereira, Medical
Organizational Affiliation
Hospital Central do Funchal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central do Funchal
City
Funchal
State/Province
Madeira
ZIP/Postal Code
9000-177
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
Yes

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Morphine vs Sufentanil PCA: Same Same or Different?

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