Opioid Analgesia, Opioid Consumption, Postoperative, Pain Management, Postoperative Pain
Conditions
Keywords
personalized analgesia, co-analgesics, personalized pain management, antinociception monitoring
Brief summary
This study is a triple-blind randomized controlled trial conducted at a tertiary care hospital in Brussels. It investigates whether a single dose of S-ketamine can reduce opioid (morphine) consumption in the first 24 hours after elective laparoscopic gynecological surgery in relatively healthy adult patients (ASA 1-2). The goal is to assess S-ketamine's effectiveness within a standardized postoperative pain management protocol.
Detailed description
This research focuses on improving postoperative pain management by evaluating the potential opioid-sparing effect of S-ketamine. While S-ketamine is known for its analgesic properties, its impact when used as a single dose alongside standardized analgesia protocols had not been previously studied in this specific surgical setting. To address this, the investigators designed a triple-blind randomized controlled trial, meaning that the patients, healthcare providers, and outcome assessors were all unaware of treatment allocation. This design minimizes bias and strengthens the reliability of the findings. The study was conducted at a tertiary care academic hospital in Brussels (Erasme Hospital), ensuring a controlled clinical environment with standardized procedures. A total of 53 adult patients were included. All participants were classified as ASA physical status 1 or 2, indicating they were either healthy or had only mild systemic disease. These patients were scheduled for elective laparoscopic gynecological surgery, a procedure typically associated with moderate postoperative pain. The primary objective of the study was to evaluate whether administering a single dose of S-ketamine could reduce postoperative opioid consumption, specifically measured as the total amount of morphine used during the first 24 hours after surgery.
Interventions
0.3 mg.kg-1 S-ketamine diluted in 50 ml of saline was administered intravenously for one hour at the beginning of the surgery, and the effect on the perioperative remifentanil consumption and the postoperative morphine consumption was studied
DRUGSaline (0.9% NaCl)
50 ml of saline was administered intravenously for one hour at the beginning of the surgery, and the effect on the perioperative remifentanil consumption and the postoperative morphine consumption was studied
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Adult patients American Society of Anesthesiologists (ASA) physical status classification I or II * Scheduled for elective laparoscopic gynecological surgery
Exclusion criteria
* Body mass index (BMI) \> 30 kg/m² * Known allergy to any drugs used in the study * Chronic pain patients or regular use of analgesics * Pregnant or breastfeeding patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative opioid consumption | from the end of the surgery up to 24 hours after surgery | The primary outcome was postoperative opioid consumption, defined as morphine consumption in the first 24 hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| perioperative opioid consumption | from the induction of anesthesia until the end of the surgery | perioperative opioid consumption, defined as remifentanil consumption per hour of surgery |
| perioperative hypnotic consumption | from the induction of anesthesia until the end of the surgery | perioperative hypnotic consumption, defined as propofol consumption per hour of surgery |
| time of emergence from anesthesia | From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery | time of emergence from anesthesia, defined as the time between cessation of medication infusion and extubation |
Countries
Belgium
Contacts
STUDY_CHAIRTurgay Tuna, PhD
HUB-ULB Brussels, Belgium
Outcome results
None listed