Pain ManagementNCT07528651
Effects of S-ketamine on Perioperative Opioid Consumption
A study testing Esketamine at low dose and Saline (0.9% NaCl) in people with Pain Management and Postoperative Pain, run by Erasme University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain Management, Postoperative Pain, Opioid Consumption, Postoperative
- What is being tested?
- Esketamine at low dose and Saline (0.9% NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Jun 2021to 21 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult patients American Society of Anesthesiologists (ASA) physical status classification I or II
- Scheduled for elective laparoscopic gynecological surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of S-ketamine on Perioperative Opioid Consumption in a Standardized Analgesia Administration Strategy. A Randomized Control Trial.
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.
Read the 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.
- Being tested
- Esketamine at low dose, Saline (0.9% NaCl)
- Keywords
- personalized analgesia, co-analgesics, personalized pain management, antinociception monitoring
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esketamine at low doseDrug
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
Saline (0.9% NaCl)Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Stdudy group | Experimental | Once the intravenous line was secured, the study syringe was connected, and the contents (0.3 mg · kg-1 S-ketamine diluted in 50 ml of saline) were administered intravenously for one hour. Receives: Drug: Esketamine at low dose; Drug: Saline (0.9% NaCl) |
| control group | Placebo comparator | Once the intravenous line was secured, the study syringe was connected, and the content (50 ml of saline) was administered intravenously for one hour. Receives: Drug: Saline (0.9% NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid consumption
The primary outcome was postoperative opioid consumption, defined as morphine consumption in the first 24 hours after surgery
Measured: from the end of the surgery up to 24 hours after surgery
Secondary outcomes (3)
perioperative opioid consumption
perioperative opioid consumption, defined as remifentanil consumption per hour of surgery
Measured: from the induction of anesthesia until the end of the surgery
perioperative hypnotic consumption
perioperative hypnotic consumption, defined as propofol consumption per hour of surgery
Measured: from the induction of anesthesia until the end of the surgery
time of emergence from anesthesia
time of emergence from anesthesia, defined as the time between cessation of medication infusion and extubation
Measured: From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start7 Jun 2021
- Primary completion21 Jun 2022
- Study completion21 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ionut Tabolcea, MD, Erasme University Hospital
- Investigators
- Turgay Tuna, PhD, Study chair, HUB-ULB Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07528651
- Sponsor's protocol ID
- P2020/667 B4062020000296
- Status last verified
- Apr 2026
- First submitted
- 31 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of S-ketamine on Perioperative Opioid Consumption in a Standardized Analgesia Administration Strategy. A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT07528651
- Acronym / sponsor ID
- P2020/667 B4062020000296
- Keywords
- personalized analgesia, co-analgesics, personalized pain management, antinociception monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 21 Jun 2022 (actual)
- Study completion
- 21 Jun 2022 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stdudy group | Experimental | Drug: Esketamine at low dose, Drug: Saline (0.9% NaCl)Once the intravenous line was secured, the study syringe was connected, and the contents (0.3 mg · kg-1 S-ketamine diluted in 50 ml of saline) were administered intravenously for one hour. |
| control group | Placebo comparator | Drug: Saline (0.9% NaCl)Once the intravenous line was secured, the study syringe was connected, and the content (50 ml of saline) was administered intravenously for one hour. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients American Society of Anesthesiologists (ASA) physical status classification I or II
- Scheduled for elective laparoscopic gynecological surgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esketamine at low dose0.3 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 | Drug | Stdudy group |
| Saline (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 | Drug | Stdudy group, control group |
Primary outcome
postoperative opioid consumption
Time frame: 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
3 secondary outcomes
perioperative opioid consumption
Time frame: from the induction of anesthesia until the end of the surgery
perioperative hypnotic consumption
Time frame: from the induction of anesthesia until the end of the surgery
time of emergence from anesthesia
Time frame: From cessation of anesthetic drug infusion until extubation, assessed at the end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Turgay Tuna, PhD study chair
HUB-ULB Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine at low dose and Saline (0.9% NaCl) in people with Pain Management and Postoperative Pain, run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid consumption (time frame: from the end of the surgery up to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.