EsketaminePhase 2/3NCT05096468
Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
A Phase 2/3 study testing S-ketamine and pregabalin in people with Esketamine and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
Trial summary
Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Esketamine, Pregabalin, Acute Postoperative Pain
- What is being tested?
- S-ketamine and pregabalin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 15 Oct 2022
- Phase
- Phase 2/3
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing elective spinal cord neoplasms resection;
- Ages between 18 and 65 years old;
- American Society of Anaesthesiology (ASA) status I-III;
- Signed informed consent.
Who cannot join
- Previous adverse reaction to ketamine, s-ketamine or pregabalin;
- Patients with a diagnosed history of severe chronic pain;
- Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
- Patients with aphasia or inability to cooperate with the pain assessments;
- Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
- Patients with a diagnosed history of psychiatric disorder;
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- Patients treated with gabapentin/pregabalin in the last three months;
- Drug abuse;
- Body mass index (BMI) > 35 kg/m2 ;
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
About this study
Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.
- Conditions
- Esketamine, Pregabalin, Acute Postoperative Pain, Neurosurgical Procedures, Perioperative Complication, Spinal Cord Neoplasms
- Being tested
- S-ketamine and pregabalin, Normal saline and placebo capsule
- Medical subject headings
- Pain, Postoperative, Spinal Cord Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-ketamine and pregabalinDrug
- Drug: Pregabalin
- 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14)
- Drug: S-ketamine infusion
- 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h
Normal saline and placebo capsuleDrug
- Drug: Placebo capsules
- Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days
- Drug: Normal saline
- 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours
| Study group | Role | What they receive |
|---|---|---|
| S-ketamine and pregabalin | Experimental | Not described Receives: Drug: S-ketamine and pregabalin |
| Normal saline and placebo capsule | Placebo comparator | Not described Receives: Drug: Normal saline and placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).
Measured: 48 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Dec 2021
- Primary completion28 Jun 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EsketamineStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruquan Han, Beijing Tiantan Hospital
- Investigators
- Ruquan Han, M.D., Ph D., Study chair, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096468
- Sponsor's protocol ID
- Z19110000661906703
- Status last verified
- Jul 2023
- First submitted
- 15 Oct 2021
- Last updated
- 6 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhou Y, Sun W, Fu Y, Wang J, Fan J, Liang Y, Jia W, Han R. Effect of esketamine combined with pregabalin on acute postsurgical pain in patients who underwent resection of spinal neoplasms: a randomized controlled trial. Pain. 2024 Sep 1;165(9):e96-e105. doi: 10.1097/j.pain.0000000000003211. Epub 2024 Mar 15.
PubMed 38501980Sun W, Wang J, Wang J, Fan J, Zhou Y, Wang Y, Han R. Esketamine combined with pregabalin on acute postoperative pain in patients undergoing resection of spinal neoplasms: study protocol for a randomized controlled trial. Trials. 2023 Feb 25;24(1):144. doi: 10.1186/s13063-023-07178-3.
PubMed 36841794
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Esketamine Combined With Pregabalin on Acute Postoperative Pain in Patients Undergoing Resection of Spinal Neoplasms.
- ClinicalTrials.gov ID
- NCT05096468
- Acronym / sponsor ID
- Z19110000661906703
- Conditions
- Esketamine, Pregabalin, Acute Postoperative Pain, Neurosurgical Procedures, Perioperative Complication, Spinal Cord Neoplasms
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 27 Oct 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.
Postsurgical pain is now known to be one of the most common and difficult-to-treat complications of surgery. severe postoperative pain can significantly impair patients' quality of life, social functioning and contribute to excessive health care expenditures. It is worth noting that acute postoperative pain may play a vital role in central sensitization and up-regulation of pain receptors, even factors implicated in the development of CPSP. According to previous studies, the incidence of postoperative pain among patients undergoing spinal surgery was nearly 80%. At the same time, perioperative pain management of patients undergoing spinal surgery has not been clearly. For the past few years, pregabalin and esketamine are becoming important roles in perioperative pain management, lots of studies have shown that these two analgesics might relieve postoperative pain. The aim of this study was to evaluate the acute analgesic effects of esketamine and pregabalin in combination after spinal cord neoplasms resection, so as to find a better way to help the patients undergoing spinal surgery keep away from the acute perioperative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-ketamine and pregabalin | Experimental | Drug: S-ketamine and pregabalin |
| Normal saline and placebo capsule | Placebo comparator | Drug: Normal saline and placebo capsule |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient undergoing elective spinal cord neoplasms resection;
- Ages between 18 and 65 years old;
- American Society of Anaesthesiology (ASA) status I-III;
- Signed informed consent.
Key exclusion criteria (10 listed)
- Previous adverse reaction to ketamine, s-ketamine or pregabalin;
- Patients with a diagnosed history of severe chronic pain;
- Patients with long-term analgesic treatment(gabapentin/opioids/ketamine);
- Patients with aphasia or inability to cooperate with the pain assessments;
- Known sever insufficiency of vitals(such as heart failure/renal dysfunction/hepatic failure);
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 |
|---|---|---|
| S-ketamine and pregabalin* Drug: Pregabalin * 150mg (2hrs) pre operatively and 75mg twice daily post operatively for 7 days(POD1-7), followed by dose reduction to 75mg once daily for 7 days(POD8-14) * Drug: S-ketamine infusion * 0.5 mg/kg bolus after induction of anesthesia +0.12 mg/kg/h continuous intravenous infusion for 48 h | Drug | S-ketamine and pregabalin |
| Normal saline and placebo capsule* Drug: Placebo capsules * Two placebo capsules (2hrs) preoperatively and twice daily post operatively for 7days, followed by dose reduction to single capsule once daily for 7days * Drug: Normal saline * 0.9% saline bolus after induction of anesthesia + intravenous infusion for 48 hours | Drug | Normal saline and placebo capsule |
Primary outcome
the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation
Time frame: 48 hours after operation
The primary outcome was the proportion of patients with acute moderate-to-severe postsurgical pain during the 48-h postoperative period (defined as a VAS score ≥ 40 mm).
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 6 Jul 2023.
- Derived from this study: PubMed 38501980Zhou Y, Sun W, Fu Y, Wang J, Fan J, Liang Y, Jia W, Han R. Effect of esketamine combined with pregabalin on acute postsurgical pain in patients who underwent resection of spinal neoplasms: a randomized controlled trial. Pain. 2024 Sep 1;165(9):e96-e105. doi: 10.1097/j.pain.0000000000003211. Epub 2024 Mar 15.
- Derived from this study: PubMed 36841794Sun W, Wang J, Wang J, Fan J, Zhou Y, Wang Y, Han R. Esketamine combined with pregabalin on acute postoperative pain in patients undergoing resection of spinal neoplasms: study protocol for a randomized controlled trial. Trials. 2023 Feb 25;24(1):144. doi: 10.1186/s13063-023-07178-3.
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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.
Ruquan Han, M.D., Ph D. study chair
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing S-ketamine and pregabalin in people with Esketamine and Pregabalin, run by Beijing Tiantan Hospital at 1 site in China.
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 4 inclusion and 10 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 6 Jul 2023. 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
the proportion of patients with acute moderate-to-severe postsurgical pain during 48h after operation (time frame: 48 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05096468, which also lists 2 linked publications.
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 6 Jul 2023.