Postoperative AnalgesiaPhase 4NCT05855798
Ketamine and Magnesium in Erector Spinae Plane Block
A Phase 4 study testing Bupivacain, Magnesium sulfate and Ketamine Hydrochloride in people with Postoperative Analgesia, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Bupivacain, Magnesium sulfate and Ketamine Hydrochloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 2 Oct 2023
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- lung resection with video-assisted thoracoscopy,
- voluntarily agree to participate in the study,
- over 18 years old,
- ASA I-III
Who cannot join
- ASA>III
- Coagulation disorders or anticoagulant agent therapy,
- Allergy or hypersensitivity to any drug to be will be used in the study,
- Epilepsy,
- High intracranial pressure,
- Unwillingness to participate in the study
- Inability to use the PCA device
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery
In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.
Read the detailed description
Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.
For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.
After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.
- Conditions
- Postoperative Analgesia
- Being tested
- Bupivacain, Magnesium sulfate, Ketamine Hydrochloride
- Keywords
- erector spinae plane block, magnesium sulphate, ketamine HCl, bupivacaine, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Bupivacaine is a local anesthetic agent commonly used in ESP block.
Magnesium sulfateDrug
Magnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness..
Ketamine HydrochlorideDrug
Ketamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Erector spinae plane block with 20 mL 0.5% bupivacaine Receives: Drug: Bupivacain |
| magnesium group | Active comparator | Erector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate Receives: Drug: Bupivacain; Drug: Magnesium sulfate |
| ketamine group | Active comparator | Erector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine Receives: Drug: Bupivacain; Drug: Ketamine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores
postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)
Measured: Change from baseline pain scores at 24 hours
morphine consumption
At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion.
Measured: Change from baseline morphine consumption at 24 hours
Secondary outcomes (1)
side effects
All of patients will visited in the thoracic surgery ward after surgery and side effects (if occured) will recorded.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2023
- Study start10 May 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05855798
- Sponsor's protocol ID
- esp01
- Status last verified
- Nov 2023
- First submitted
- 4 May 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Effects of Magnesium Sulphate and Ketamine Added to 0.5% Bupivacaine for Erector Spinae Plane Block in Patients Undergoing Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT05855798
- Acronym / sponsor ID
- esp01
- Conditions
- Postoperative Analgesia
- Keywords
- erector spinae plane block, magnesium sulphate, ketamine HCl, bupivacaine, analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 11 May 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.
In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.
Detailed description
Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.
For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.
After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: BupivacainErector spinae plane block with 20 mL 0.5% bupivacaine |
| magnesium group | Active comparator | Drug: Bupivacain, Drug: Magnesium sulfateErector spinae plane block with 20 mL 0.5% bupivacaine+150 mg magnesium sulphate |
| ketamine group | Active comparator | Drug: Bupivacain, Drug: Ketamine HydrochlorideErector spinae plane block with 20 mL 0.5% bupivacaine+2 mg/kg ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- lung resection with video-assisted thoracoscopy,
- voluntarily agree to participate in the study,
- over 18 years old,
- ASA I-III
Key exclusion criteria (7 listed)
- ASA>III
- Coagulation disorders or anticoagulant agent therapy,
- Allergy or hypersensitivity to any drug to be will be used in the study,
- Epilepsy,
- High intracranial pressure,
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 |
|---|---|---|
| BupivacainBupivacaine is a local anesthetic agent commonly used in ESP block. | Drug | control group, ketamine group, magnesium group |
| Magnesium sulfateMagnesium is an adjuvant agent that can be added to the local anesthetic agent to increase analgesic effectiveness.. | Drug | magnesium group |
| Ketamine HydrochlorideKetamine Hydrochloride is an also adjuvant agent that can be added to the local anesthetic to increase analgesic effectiveness. | Drug | ketamine group |
Primary outcome
pain scores
Time frame: Change from baseline pain scores at 24 hours
postoperative pain scores will recorded used Visual Analog Scale (VAS, 0= no pain, 10=worst pain)
morphine consumption
Time frame: Change from baseline morphine consumption at 24 hours
At the end of the surgery, patients will allowed to use the patient controlled analgesia (PCA) device. The PCA will deliver bolus doses of morphine (0,02 mg/kg) every 10 minutes without a background infusion.
1 secondary outcome
side effects
Time frame: postoperative 24 hours
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 19 Sep 2024.
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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 Bupivacain, Magnesium sulfate and Ketamine Hydrochloride in people with Postoperative Analgesia, run by Cukurova University at 1 site in Turkey (Türkiye).
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 7 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 19 Sep 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 Turkey (Türkiye). 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?
pain scores (time frame: Change from baseline pain scores at 24 hours). The study lists 2 primary outcomes in all. 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 19 Sep 2024.