Analgesia, Chronic Pain, Patient Satisfaction, Post Operative Pain
Conditions
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.
Interventions
DRUGSufentanil 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.
DRUGIntravenous 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.
Sponsors
Hospital Central do Funchal
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain control | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects associated with analgesia | 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 |
| Total daily dose of opioid | Evaluation at 24 hours and 48 hours after surgery | Evaluation of total daily dose of each drug |
| Patients satisfaction with analgesia | Evaluation at 24 hours and 48 hours after surgery | Evaluation of patient satisfaction using a qualitative scale: Poor; Average; Good; Excellent |
| Impact of the treatment on the quality of postoperative recovery | Evaluation at 24 hours after surgery | Evaluation of recovery with application of validated quality of recovery score (QoR-15) questionnaire |
| Incidence of postoperative chronic pain | 4 months after surgey | Assessment to persistent postoperative pain by completing the Brief Pain Inventory |
Countries
Portugal
Outcome results
None listed