KetaminePhase 4NCT06011746
Adding Ketamine to Levobupivacaine in Paravertebral Block in Thoracotomy
A Phase 4 study testing Ketamine + Levobupivacaine and Levobupivacaine in people with Ketamine and Levobupivacaine, run by Tanta University at 1 site in Egypt.
Trial summary
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ketamine, Levobupivacaine, Paravertebral Block
- What is being tested?
- Ketamine + Levobupivacaine and Levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2023to 26 Jan 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years.
- Both sexes.
- ASA (American Society of Anesthesiology) physical status II-III.
- Scheduled for open thoracotomy.
Who cannot join
- Contraindications to or failed paravertebral block .
- Body mass index (BMI) >35 kg/m2.
- The likelihood of postoperative mechanical ventilation.
- Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
- Hypersensitivity to ketamine or levobupivacaine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
Read the detailed description
Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.
Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.
- Conditions
- Ketamine, Levobupivacaine, Paravertebral Block, Acute Pain, Chronic Pain
- Being tested
- Ketamine + Levobupivacaine, Levobupivacaine
- Medical subject headings
- Acute Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + LevobupivacaineDrug
Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg)
LevobupivacaineDrug
Skin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Experimental | patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)). Receives: Drug: Ketamine + Levobupivacaine |
| Control Group | Active comparator | patients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline) Receives: Drug: Levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesia
The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.
Measured: 24 hour postoperatively
Secondary outcomes (4)
Total amount of morphine consumption
The total morphine consumption in the 1st 24h postoperative will be recorded. Patients can receive incremental doses of meperidine 0.5 mg/kg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.
Measured: 24 hour postoperatively
Pain intensity during rest
Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.
Measured: 48 hour postoperatively
Pain intensity during deep breathing
Postoperative pain using numeric rating scale at rest and during coughing or movement will be measured at Post-anesthesia care unit, 1h, 2h. 4hr, 6h, 8h, 12h, 18h, 24h, 36h and 48h postoperative.
Measured: 48 hour postoperatively
Incidence of chronic pain
The neuropathic PTPS cases were screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS with a neuropathic component were grade 2 (probable) or 3 (definite), that is, GSNP ≥2
Measured: three months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start30 Aug 2023
- Primary completion26 Jan 2024
- Study completion26 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KetamineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011746
- Sponsor's protocol ID
- 36264PR244/6/23
- Status last verified
- Feb 2024
- First submitted
- 13 Jul 2023
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adding Ketamine to Levobupivacaine in Paravertebral Block on Acute and Chronic Pain in Thoracotomy: a Randomized Controlled Double-blinded Trial
- ClinicalTrials.gov ID
- NCT06011746
- Acronym / sponsor ID
- 36264PR244/6/23
- Conditions
- Ketamine, Levobupivacaine, Paravertebral Block, Acute Pain, Chronic Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 30 Aug 2023 (actual)
- Primary completion
- 26 Jan 2024 (actual)
- Study completion
- 26 Jan 2024 (actual)
- First posted
- 25 Aug 2023 (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.
To evaluate the role of adding ketamine to levobupivacaine in PVB on acute and chronic pain in thoracotomy
Detailed description
Several adjuvants have been added to them to enhance the effects of those blocks. Dexamethasone, morphine, dexmedetomidine, clonidine, ketamine, and magnesium sulphate are some of them. results are variable.
Ketamine blocks N-Methyl-D-Aspartate (NMDA) receptors in the spinal cord. It is also considered to influence voltage sensitive Calcium ions channels, opioid receptors, and monoaminergic receptors. Therefore, it is considered overall to affect nociception.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Experimental | Drug: Ketamine + Levobupivacainepatients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml ketamine (50 mg)). |
| Control Group | Active comparator | Drug: Levobupivacainepatients will receive paravertebral block (19 mL of 0.5% levobupivacaine + 1 ml normal saline) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-75 years.
- Both sexes.
- ASA (American Society of Anesthesiology) physical status II-III.
- Scheduled for open thoracotomy.
Key exclusion criteria (5 listed)
- Contraindications to or failed paravertebral block .
- Body mass index (BMI) >35 kg/m2.
- The likelihood of postoperative mechanical ventilation.
- Patients with coagulopathy, poorly controlled diabetes mellitus, depression or other psychiatric disorders that required antidepressant drugs, alcohol, or recreational drug addiction.
- Hypersensitivity to ketamine or levobupivacaine.
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 |
|---|---|---|
| Ketamine + LevobupivacaineSkin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with 1ml ketamine (50mg) | Drug | Ketamine Group |
| LevobupivacaineSkin infiltration will be done using 3 ml lidocaine 2% and a 22-gauage block needle will be advanced using the in-plane approach craniocaudally. Once the costotransverse ligament is reached, negative aspiration of blood and air will be confirmed. Under ultrasound visualization, 19 mL of 0.5% levobupivacaine with (50mg) or normal saline | Drug | Control Group |
Primary outcome
Time to first analgesia
Time frame: 24 hour postoperatively
The time till the first rescue of analgesia of morphine. Patients can receive incremental doses of morphine 3 mg intravenously as rescue analgesia if the numeric rating scale (NRS) pain score is > 3.
4 secondary outcomes
Total amount of morphine consumption
Time frame: 24 hour postoperatively
Pain intensity during rest
Time frame: 48 hour postoperatively
Pain intensity during deep breathing
Time frame: 48 hour postoperatively
Incidence of chronic pain
Time frame: three months postoperatively
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 13 Feb 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 + Levobupivacaine and Levobupivacaine in people with Ketamine and Levobupivacaine, run by Tanta University at 1 site in Egypt.
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 5 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 13 Feb 2024. 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 Egypt. 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. 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?
Time to first analgesia (time frame: 24 hour postoperatively). 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 13 Feb 2024.