Morphine vs Sufentanil PCA: Same Same or Different?

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05259098
• Other study ID #: 35/2019
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: October 31, 2020

Study information

• Verified date: February 2022
• Source: Hospital Central do Funchal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 31, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Analgesia
• Chronic Pain
• Pain, Postoperative
• Patient Satisfaction
• Post Operative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Portugal	Hospital Central do Funchal	Funchal	Madeira

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Central do Funchal

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Total daily dose of opioid	Evaluation of total daily dose of each drug	Evaluation at 24 hours and 48 hours after surgery
Secondary	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
Secondary	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
Secondary	Incidence of postoperative chronic pain	Assessment to persistent postoperative pain by completing the Brief Pain Inventory	4 months after surgey