Postoperative PainNCT04895072
Injection Rate and Erector Spinae Plane Block
A study testing Standard group and Long group in people with Postoperative Pain and Breast Surgery, run by Antalya Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
To evaluate the effect of injection rate on the block sensory level in the ESP block. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Surgery
- What is being tested?
- Standard group and Long group
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 May 2021to 30 Nov 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged between eighteen and sixty-five
- ASA I-III
- undergo elective breast cancer surgery
Who cannot join
- under 18 years of age or over 65 years of age
- ASA IV and above
- declined to give written informed consent
- contraindications of peripheral blocks or local anesthetic infiltration
- history of allergy against local anesthetics
- chronic pain history
- history of hepatic, neuromuscular, cardiac and/or renal failure
- infection at the injection site
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
Antalya, 07100
About this study
Official title: Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block
To evaluate the effect of injection rate on the block sensory level in the ESP block.
Read the detailed description
Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.
- Conditions
- Postoperative Pain, Breast Surgery
- Being tested
- Standard group, Long group
- Keywords
- Erector spinae plane (ESP) block, Postoperative Pain, Breast Surgery
- Medical subject headings
- Pain, Postoperative, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard groupProcedure or surgery
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate.
Long groupProcedure or surgery
Ultrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate.
| Study group | Role | What they receive |
|---|---|---|
| Standard group | Active comparator | standard injection rate will be applied Receives: Procedure: Standard group |
| Long group | Active comparator | long injection rate will be applied Receives: Procedure: Long group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block sensory level
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block
Measured: 12 hours
Secondary outcomes (2)
Postoperative tramadol consumption
Postoperative tramadol consumption will be recorded at 24 hours
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start17 May 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Antalya Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Arzu Karaveli, Principal investigator, Antalya TRH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895072
- Sponsor's protocol ID
- 4/5
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
PubMed 32517405
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Injection Rate on the Block Sensory Level in the Erector Spine Plane Block
- ClinicalTrials.gov ID
- NCT04895072
- Acronym / sponsor ID
- 4/5
- Conditions
- Postoperative Pain, Breast Surgery
- Keywords
- Erector spinae plane (ESP) block, Postoperative Pain, Breast Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Antalya Training and Research HospitalOther government
- Study start
- 17 May 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 20 May 2021 (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 effect of injection rate on the block sensory level in the ESP block.
Detailed description
Many women experience severe acute postoperative pain after breast cancer surgery. Regional techniques are frequently used as a part of multimodal analgesia in breast surgery. Ultrasound-guided erector spinae plane (ESP) block is a preferred method to reduce the postoperative opioid requirement for postoperative pain management. In this study, we aimed to evaluate the effect of injection rate on the block sensory level in the ESP block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard group | Active comparator | Procedure: Standard groupstandard injection rate will be applied |
| Long group | Active comparator | Procedure: Long grouplong injection rate will be applied |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged between eighteen and sixty-five
- ASA I-III
- undergo elective breast cancer surgery
Key exclusion criteria (8 listed)
- under 18 years of age or over 65 years of age
- ASA IV and above
- declined to give written informed consent
- contraindications of peripheral blocks or local anesthetic infiltration
- history of allergy against 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 |
|---|---|---|
| Standard groupUltrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a standard injection rate. | Procedure or surgery | Standard group |
| Long groupUltrasound-guided ESP block with 20 mL %0.375 bupivacaine will be administered at a long injection rate. | Procedure or surgery | Long group |
Primary outcome
Block sensory level
Time frame: 12 hours
Number (average) of dermatomes with sensory block with pinprick and cold methods after the ESP block
2 secondary outcomes
Postoperative tramadol consumption
Time frame: 24 hours
Assesment of postoperative analgesia
Time frame: 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 4 Jan 2022.
- Background: PubMed 32517405Barrios A, Camelo J, Gomez J, Forero M, Peng PWH, Visbal K, Cadavid A. Evaluation of Sensory Mapping of Erector Spinae Plane Block. Pain Physician. 2020 Jun;23(3):E289-E296.
- 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.
Arzu Karaveli principal investigator
Antalya TRH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard group and Long group in people with Postoperative Pain and Breast Surgery, 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 8 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 4 Jan 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?
Block sensory level (time frame: 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04895072, which also lists 1 linked publication.
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 4 Jan 2022.