PainNCT04224844
Erector Spinae Plane Block for Carotid Endarterectomy
A study testing Erector spinae plane block in people with Pain, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2020to Feb 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing carotid endarterectomy
- American Society of Anesthesiologists class 2 to 3
- Ability to consent
Who cannot join
- inability to communicate
- not understand the aim and objectives of the study
- not provide informed written consent
- contraindications for the block (local infection, coagulation disorders)
- hypersensitivity to the local anesthetics
- refusal of regional anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-Guided Spinae Plane Block for Perioperative Pain Control in Carotid Endarterectomy.
The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.
Read the detailed description
Patients who decided to participate in the study will be randomized into 2 groups: Erector Spinae Plane Block Group (Group E) and Control Group (Group C). Intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.
- Conditions
- Pain
- Being tested
- Erector spinae plane block, Control group
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockOther
The block will be performed before the surgery. The spinous process of T2 or T3 wil be identified by an ultrasound guide, with the probe positioned longitudinally. A block needle will be inserted in the caudo-cephal direction. After the injection site is confirmed by 3 ml of physiological solution and correct position of the needle tip is confirmed, bupivacaine will be injected. The patients assigned to this group will also receive an intravenous patient-controlled analgesia device containing tramadol postoperatively.
Control groupOther
Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group (Group 1) | Active comparator | Patients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol. Receives: Other: Erector spinae plane block |
| Control group (Group 2) | Active comparator | Control group will receive only intravenous patient-controlled analgesia device containing tramadol. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours tramadol consumption
Total tramadol consumption in milligrams at 24 hrs will be scored.
Measured: 24 hours
6 hours tramadol consumption
Total tramadol consumption in milligrams at 6 hrs will be scored.
Measured: 6 hours
12 hours tramadol consumption
Total tramadol consumption in milligrams at 12 hrs will be scored.
Measured: 12 hours
Assesment of postoperative analgesia
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 24 hrs.
Measured: 24 hours
Assesment of postoperative analgesia
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 6 hours.
Measured: 6 hours
Assesment of postoperative analgesia
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 12 hours.
Measured: 12 hours
Secondary outcomes (1)
Amount of use of intraoperative local anesthetic.
Intraoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain). When intraoperative VAS is >3, supplemental local anesthetic will be administered to the surgical area by the surgeon. Amount of total local anesthetic in milligrams will be recorded at the end of the surgery.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startSep 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionFeb 2021 (estimated)
Why it stopped: not recruiting, awaiting for changes in IRB
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, M.D., Principal investigator, Antalya Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224844
- Sponsor's protocol ID
- AntalyaTRH029
- Status last verified
- Apr 2020
- First submitted
- 7 Jan 2020
- Last updated
- 30 Apr 2020
- 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 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Spinae Plane Block for Perioperative Pain Control in Carotid Endarterectomy.
- ClinicalTrials.gov ID
- NCT04224844
- Acronym / sponsor ID
- AntalyaTRH029
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: not recruiting, awaiting for changes in IRB
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- Sep 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
The purpose of this study is to test the hypothesis that erector spinae plane block will decrease intraoperative local anesthetic and postoperative analgesic consumption in patients undergoing carotid endarterectomy.
Detailed description
Patients who decided to participate in the study will be randomized into 2 groups: Erector Spinae Plane Block Group (Group E) and Control Group (Group C). Intraoperative local anesthetic consumption, postoperative tramadol consumption, intraoperative and pain scores, hemodynamic parameters and patient satisfaction will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group (Group 1) | Active comparator | Other: Erector spinae plane blockPatients will receive erector spinae plane block in addition to intravenous patient-controlled analgesia device containing tramadol. |
| Control group (Group 2) | Active comparator | Other: Control groupControl group will receive only intravenous patient-controlled analgesia device containing tramadol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing carotid endarterectomy
- American Society of Anesthesiologists class 2 to 3
- Ability to consent
Key exclusion criteria (6 listed)
- inability to communicate
- not understand the aim and objectives of the study
- not provide informed written consent
- contraindications for the block (local infection, coagulation disorders)
- hypersensitivity to the local anesthetics
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 spinae plane blockThe block will be performed before the surgery. The spinous process of T2 or T3 wil be identified by an ultrasound guide, with the probe positioned longitudinally. A block needle will be inserted in the caudo-cephal direction. After the injection site is confirmed by 3 ml of physiological solution and correct position of the needle tip is confirmed, bupivacaine will be injected. The patients assigned to this group will also receive an intravenous patient-controlled analgesia device containing tramadol postoperatively. | Other | Erector spinae plane block group (Group 1) |
| Control groupControl group will receive only patient-controlled analgesia device containing tramadol. No block will be performed. | Other | Control group (Group 2) |
Primary outcome
24 hours tramadol consumption
Time frame: 24 hours
Total tramadol consumption in milligrams at 24 hrs will be scored.
6 hours tramadol consumption
Time frame: 6 hours
Total tramadol consumption in milligrams at 6 hrs will be scored.
12 hours tramadol consumption
Time frame: 12 hours
Total tramadol consumption in milligrams at 12 hrs will be scored.
Assesment of postoperative analgesia
Time frame: 24 hours
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 24 hrs.
Assesment of postoperative analgesia
Time frame: 6 hours
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 6 hours.
Assesment of postoperative analgesia
Time frame: 12 hours
Post operative pain scores will be assessed using a numerical rating scala (NRS) (from 0=no pain, to10= worst pain imaginable) at 12 hours.
1 secondary outcome
Amount of use of intraoperative local anesthetic.
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2020.
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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.
Ali Sait Kavakli, M.D. principal investigator
Antalya Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block in people with Pain, run by Antalya Training and Research Hospital 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 3 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: paused, as of the sponsor's last update on 30 Apr 2020. 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.
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?
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?
24 hours tramadol consumption (time frame: 24 hours). The study lists 6 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 30 Apr 2020.