Pain, PostoperativeNCT06332313
Erector Spina Plane Block Volume Comparison
A study testing erector spina plane block in people with Pain, Postoperative, run by Kahramanmaras Sutcu Imam University.
Trial summary
After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- erector spina plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 12 Jun 2024to 5 Dec 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18-65 years old
- ASA I-II classification
- Body mass index ≤40
- Helsinki Declaration after obtaining their written consent
- Patients undergoing Retrograde Intrarenal Surgery
Who cannot join
- Allergy history against local anesthetics
- Contraindications for peripheral nerve blocks (local infection,coagulopathy etc.)
- Psychiatric disorders or receiving antipsychotic drugs
- Patients with contraindications for spinal anesthesia,
- Coagulopathy,
- Known allergies to the drugs to be used,
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- Infection at the site of the procedure,
- Dermatological diseases such as psoriasis that prevent aseptic preparation of the skin at the injection site,
- Septicemia or bacteremia,
- Shock or severe hypovolemia,
- Patients who are not volunteers
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Patient-Controlled Analgesia and Erector Spina Blocks Applied at Different Volumes in Postoperative Pain Management in Retrograde Intrarenal Surgery Operations
After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.
Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded
- Conditions
- Pain, Postoperative
- Being tested
- erector spina plane block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spina plane blockProcedure or surgery
ESP block is a method used to provide postoperative analgesia by injecting local anesthetic between the erector spinae muscle and the transverse process of the vertebra under ultrasound guidance, targeting the dorsal and ventral rami of thoracic and abdominal spinal nerves. The aim of this randomized controlled study is to observe whether there is a difference in tramadol consumption within 24 hours after surgery between patients who undergo RIRS operations at T11 level with different volumes of ESP blocks performed under ultrasound guidance before general anesthesia induction.
| Study group | Role | What they receive |
|---|---|---|
| Group control | No intervention | The control group is followed with PCA without a block. |
| Group E20 | Active comparator | Group E20 receive PCA with 20cc volume of ESP block Receives: Procedure: erector spina plane block |
| Group E30 | Active comparator | Group E30 receive PCA with 30 volume of ESP block çevir Receives: Procedure: erector spina plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups.
Measured: 2, 4, 6, 12, 18, and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2024
- Study start12 Jun 2024 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ömer Faruk Boran, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06332313
- Sponsor's protocol ID
- 2023/10/05
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 27 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient-Controlled Analgesia and Erector Spina Blocks Applied at Different Volumes in Postoperative Pain Management in Retrograde Intrarenal Surgery Operations
- ClinicalTrials.gov ID
- NCT06332313
- Acronym / sponsor ID
- 2023/10/05
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 12 Jun 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 27 Mar 2024 (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.
After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic, 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index ≤40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent. Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks (local infection,coagulopathy etc.) or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study. Routine preoperative evaluation including age, height, and weight measurements will be performed on all patients at pre-anesthesia clinic.
Patients will be randomized into three groups: Group K, who will receive analgesia with patient-controlled analgesia (PCA) with tramadol only; Group E20, who will receive PCA with 20cc volume of ESP block; and Group E30, who will receive PCA with 30cc volume of ESP block. After standard general anesthesia induction and endotracheal intubation, one of the three analgesic methods will be randomly applied, and the surgery will commence. All patients will receive patient-controlled analgesia. Patients in Group K will not receive any local anesthetic injection. When the patient is transferred to the postoperative care unit, intravenous PCA device will be attached, and pain scores using Visual Analog Scale (VAS), rated from 0 (no pain) to 10 (worst pain ever experienced), at rest and during coughing will be evaluated at 2, 4, 6, 12, 18, and 24 hours postoperatively. The values will be recorded. When the patient experiences pain, analgesic agents will be administered according to the patient-controlled analgesia protocol. The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded. Postoperative QUIPS: Quality Improvement in Postoperative Pain Management questionnaire will be administered, and side effects such as nausea/vomiting or sedation will be noted. Additionally, patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent (very poor/poor/fair/good/excellent)will also be evaluated and recorded
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group control | No intervention | –The control group is followed with PCA without a block. |
| Group E20 | Active comparator | Procedure: erector spina plane blockGroup E20 receive PCA with 20cc volume of ESP block |
| Group E30 | Active comparator | Procedure: erector spina plane blockGroup E30 receive PCA with 30 volume of ESP block çevir |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- between 18-65 years old
- ASA I-II classification
- Body mass index ≤40
- Helsinki Declaration after obtaining their written consent
- Patients undergoing Retrograde Intrarenal Surgery
Key exclusion criteria (11 listed)
- Allergy history against local anesthetics
- Contraindications for peripheral nerve blocks (local infection,coagulopathy etc.)
- Psychiatric disorders or receiving antipsychotic drugs
- Patients with contraindications for spinal anesthesia,
- Coagulopathy,
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 |
|---|---|---|
| erector spina plane blockESP block is a method used to provide postoperative analgesia by injecting local anesthetic between the erector spinae muscle and the transverse process of the vertebra under ultrasound guidance, targeting the dorsal and ventral rami of thoracic and abdominal spinal nerves. The aim of this randomized controlled study is to observe whether there is a difference in tramadol consumption within 24 hours after surgery between patients who undergo RIRS operations at T11 level with different volumes of ESP blocks performed under ultrasound guidance before general anesthesia induction. | Procedure or surgery | Group E20, Group E30 |
Primary outcome
The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups.
Time frame: 2, 4, 6, 12, 18, and 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing erector spina plane block in people with Pain, Postoperative, run by Kahramanmaras Sutcu Imam University.
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 11 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: status not confirmed, as of the sponsor's last update on 27 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Turpçu (+905070699626, drmustafaturpcu1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The aim is to observe the difference in tramadol consumption within the first 24 hours after surgery in 3 groups. (time frame: 2, 4, 6, 12, 18, and 24 hours). 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 2024.