Pain, PostoperativePhase 4KETASONANCT04751175
Management of Pain in Lumbar Arthrodesis
A Phase 4 study testing Ketamine, Dexamethasone and Physiologic saline in people with Pain, Postoperative, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Ketamine, Dexamethasone and Physiologic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 4 Jul 2013to 31 Dec 2025
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female
- Age> 18 years
- ASA I-III.
- Lumbar arthrodesis.
- Patients who have signed the preoperative informed consent for participation in the study.
Who cannot join
- Unstable coronary heart disease
- Glaucoma
- History of allergy to ketamine, dexamethasone, or morphic chloride
- Dementia or inability to understand IC and study
- Pluricomplicated diabetes mellitus difficult to control
- Patients who have taken an experimental drug 30 days before the start of the study or who are included in any type of study of an experimental drug
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.
Read the detailed description
The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.
- Conditions
- Pain, Postoperative
- Being tested
- Ketamine, Dexamethasone, Physiologic saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization
DexamethasoneDrug
A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.
Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration
Physiologic salineDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Ketamina bolus plus Dexamethasone bolus plus infusion ketamine | Experimental | Ketamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA) Receives: Drug: Ketamine; Drug: Dexamethasone |
| Ketamine bolus plus ketamine infusion | Experimental | Ketamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA. Receives: Drug: Ketamine; Drug: Physiologic saline |
| Dexametasone arm | Active comparator | Saline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA Receives: Drug: Dexamethasone; Drug: Physiologic saline |
| Saline bolus | Placebo comparator | Saline bolus + saline bolus + saline infusion up to three hours after admission to the URPA Receives: Drug: Physiologic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated
Consumption of morphics
Measured: 4 hours post operative
Secondary outcomes (3)
Incidence of postoperative nausea and vomiting (PONV).
Incidence of postoperative nausea and vomiting
Measured: 4 hours post operative
Efficay of study treatment regarding pain at 3 postoperative months
Pain at 3 postoperative months assessed by EVA scale pain. This is a visual analogue scale regarding pain.It consists of a 10-centimeter horizontal line, at the ends of which are the extreme expressions of a symptom. In the left is the absence or less intensity and in the right the greater intensity. The patient is asked to mark on the line the point that indicates the intensity and measure it with a millimeter ruler. The intensity is expressed in centimeters or millimeters. The evaluation will be: 1.Mild pain if the patient scores pain less than 3. 2.Moderate pain if the evaluation is between 4 and 7. 3.Severe pain if the evaluation is equal to or greater than 8.
Measured: 3 months
Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)
Rate of patients that presented adverse events
Measured: 4 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start4 Jul 2013
- Primary completion31 Jul 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Emili Leon, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Emili Leon, MD, Principal investigator, Hospital Dr Josep Trueta and Hospital Santa Caterina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751175
- Sponsor's protocol ID
- EudraCT number 2012-002518-38
- Acronym
- KETASONA
- Status last verified
- Mar 2026
- First submitted
- 6 Aug 2020
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine and Dexametasone in the Management of Pain in Lumbar Arthrodesis
- ClinicalTrials.gov ID
- NCT04751175
- Acronym / sponsor ID
- KETASONA / EudraCT number 2012-002518-38
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Study start
- 4 Jul 2013 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 12 Feb 2021 (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.
KETAMINE AND DEXAMETASONE IN THE MANAGEMENT OF PAIN IN LUMBAR ARTHRODESISPhase IV prospective randomized controlled single-center clinical trial to determine the effect of intravenous ketamine and dexamethasone administration perioperatively in patients undergoing lumbar arthrodesis.
Detailed description
The need to carry out this study is to evaluate the analgesic effects after the administration of ketamine and dexamethasone intravenously perioperatively in patients undergoing lumbar arthrodesis and, likewise, study the incidence of pain and protocolize perioperative analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Single-center, controlled, prospective and randomized clinical trial, phase IV, to determine the effect of perioperative intravenous administration of ketamine and dexamethasone in patients undergoing lumbar arthrodesis
| Arm | Type | Receives |
|---|---|---|
| Ketamina bolus plus Dexamethasone bolus plus infusion ketamine | Experimental | Drug: Ketamine, Drug: DexamethasoneKetamine bolus (0.5 mg / kg) + dexamethasone 0.1 mg / kg bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the Post-Anesthesia Resuscitation Unit (URPA) |
| Ketamine bolus plus ketamine infusion | Experimental | Drug: Ketamine, Drug: Physiologic salineKetamine bolus (0.5 mg / kg) + physiological serum bolus + ketamine infusion (0.1 mg / kg / h) up to three hours after admission to the URPA. |
| Dexametasone arm | Active comparator | Drug: Dexamethasone, Drug: Physiologic salineSaline bolus + dexamethasone bolus 0.1 mg / kg + saline infusion up to three hours after admission in URPA |
| Saline bolus | Placebo comparator | Drug: Physiologic salineSaline bolus + saline bolus + saline infusion up to three hours after admission to the URPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Age> 18 years
- ASA I-III.
- Lumbar arthrodesis.
- Patients who have signed the preoperative informed consent for participation in the study.
Key exclusion criteria (6 listed)
- Unstable coronary heart disease
- Glaucoma
- History of allergy to ketamine, dexamethasone, or morphic chloride
- Dementia or inability to understand IC and study
- Pluricomplicated diabetes mellitus difficult to control
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 |
|---|---|---|
| KetamineKetamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization | Drug | Ketamina bolus plus Dexamethasone bolus plus infusion ketamine, Ketamine bolus plus ketamine infusion |
| DexamethasoneA meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery. Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration | Drug | Dexametasone arm, Ketamina bolus plus Dexamethasone bolus plus infusion ketamine |
| Physiologic salineplacebo | Drug | Dexametasone arm, Ketamine bolus plus ketamine infusion, Saline bolus |
Primary outcome
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated
Time frame: 4 hours post operative
Consumption of morphics
3 secondary outcomes
Incidence of postoperative nausea and vomiting (PONV).
Time frame: 4 hours post operative
Efficay of study treatment regarding pain at 3 postoperative months
Time frame: 3 months
Adverse side effects:Hallucinations / Delirium.Sedation. Diplopia, Hyperglycemia Respiratory depression (Sat <90%)
Time frame: 4 hours post operative
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 27 Mar 2026.
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Emili Leon, MD principal investigator
Hospital Dr Josep Trueta and Hospital Santa Caterina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine, Dexamethasone and Physiologic saline in people with Pain, Postoperative, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
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 5 inclusion and 6 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 27 Mar 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 Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy of Morphic Chloride (PCA) to treat pain during the post-operative period. Consumption of morphics will be evaluated (time frame: 4 hours post operative). 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 27 Mar 2026.