Postoperative PainNCT05244031
Intraoperative Placement of Superficial Erector Spinae Plane Block; A New Approach in Spine Surgery
A study testing superficial erector spina plane block and Standard (opioid-based) analgesia in people with Postoperative Pain and Spine Deformity, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Spine Deformity, Spine Injury
- What is being tested?
- superficial erector spina plane block and Standard (opioid-based) analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2021to 7 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages of 18-65
- Patients who will undergo spine surgery (at least two level)
- ASA I-II-III patients
Who cannot join
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- Coagulopathy
- Patients with ASA IV-V
- Single level surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Istanbul, Bakirkoy, 34147
About this study
Official title: Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.
Read the detailed description
46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.
- Being tested
- superficial erector spina plane block, Standard (opioid-based) analgesia
- Keywords
- Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic
- Medical subject headings
- Pain, Postoperative, Spinal Injuries, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
superficial erector spina plane blockProcedure or surgery
The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia
Standard (opioid-based) analgesiaProcedure or surgery
The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| Superficial ESP | Active comparator | The investigators performed superficial erector spina plane block to that patient group for postoperative analgesia Receives: Procedure: superficial erector spina plane block |
| Control group | Active comparator | The investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia Receives: Procedure: Standard (opioid-based) analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS scores of patients
NRS at 1, 6,12, 18, 24, 36, 48th hours
Measured: 48 hours postoperatively
Secondary outcomes (1)
Postoperative 48-hours total morphine consumption
This will be measured only one time by pca device at the 48th hour after surgery.
Measured: 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start10 May 2021
- Primary completion7 Feb 2022
- Study completion7 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gokhan Sertcakacilar, MD, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244031
- Sponsor's protocol ID
- 2021-271
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Placement of Superficial Erector Spinae Plane Block in Spine Surgery; An Effective Approach at Enhanced Recovery After Spine Surgery
- ClinicalTrials.gov ID
- NCT05244031
- Acronym / sponsor ID
- 2021-271
- Keywords
- Postoperative pain, Superficial Erector Spinae Plane Block, Spine Surgery, Local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 10 May 2021 (actual)
- Primary completion
- 7 Feb 2022 (actual)
- Study completion
- 7 Feb 2022 (actual)
- First posted
- 17 Feb 2022 (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.
Major spine surgery causes severe postoperative pain. The primary objective of this randomized controlled study is to compare the effect of ultrasound (US)-guided superficial erector spinae plane (ESP) block on 48-hour postoperative cumulative opioid requirements with standard (opioid-based) analgesia.
Detailed description
46 patients (ASA I-II-III) between 18 and 65 years of age, who were to undergo spine surgery, were randomized and divided into two groups. (23 patients in each of the control and superficial ESP groups). Superficial ESP block was performed for SESP group and standard (opioid-based) analgesia performed in the control group. Postoperative analgesia was provided by intravenous morphine infusion using a patient-controlled analgesia device. Postoperative numeric rating scale values were the primary outcome measure. 24-hour total morphine consumption was secondary outcome measure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial ESP | Active comparator | Procedure: superficial erector spina plane blockThe investigators performed superficial erector spina plane block to that patient group for postoperative analgesia |
| Control group | Active comparator | Procedure: Standard (opioid-based) analgesiaThe investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages of 18-65
- Patients who will undergo spine surgery (at least two level)
- ASA I-II-III patients
Key exclusion criteria (7 listed)
- Clinically known local anesthetic allergy
- Morbid obesity (body mass index>40 kg m2)
- Clinically diagnosis of opioid, alcohol and substance dependence
- Clinically diagnosis of psychiatric disease
- 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 |
|---|---|---|
| superficial erector spina plane blockThe investigators performed superficial erector spina plane block to that patient group for postoperative analgesia | Procedure or surgery | Superficial ESP |
| Standard (opioid-based) analgesiaThe investigators performed intravenous opioid infusion with PCA to that patient group for postoperative analgesia | Procedure or surgery | Control group |
Primary outcome
NRS scores of patients
Time frame: 48 hours postoperatively
NRS at 1, 6,12, 18, 24, 36, 48th hours
1 secondary outcome
Postoperative 48-hours total morphine consumption
Time frame: 48 hours 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 3 Mar 2022.
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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 study testing superficial erector spina plane block and Standard (opioid-based) analgesia in people with Postoperative Pain and Spine Deformity, run by Bakirkoy Dr. Sadi Konuk Research and Training 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 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 3 Mar 2022. 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?
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?
NRS scores of patients (time frame: 48 hours 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 3 Mar 2022.