Postoperative PainNCT03621345
Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery
A study testing Erector spinae plane block in people with Postoperative Pain and Breast Hypertrophy, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Postoperative Pain, Breast Hypertrophy
- What is being tested?
- Erector spinae plane block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2018to 1 Sep 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery
Who cannot join
- Coagulopathy
- Allergy to amide-type local anesthetics
- Infection at the ESP block injection site
- Severe obesity (BMI > 35 kg/m2)
- Liver or renal deficiency
- Patients with anatomical deformities
- Recent use of analgesic drugs
- Patient refusal or inability to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.
- Conditions
- Postoperative Pain, Breast Hypertrophy
- Being tested
- Erector spinae plane block, sham block
- Medical subject headings
- Pain, Postoperative, Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockProcedure or surgery
Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.
sham blockOther
A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.
| Study group | Role | What they receive |
|---|---|---|
| ESP block group | Active comparator | The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain.
Interventions:
Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization Receives: Procedure: Erector spinae plane block |
| sham block | Sham comparator | A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied.
Intervention: Sham block Other: Standard Pain Followup and Monitorization Receives: Other: sham block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
Morphine consumption in Patient Controlled Analgesia device
Measured: 24 hours
Secondary outcomes (10)
Intraoperative anesthetic consumption
Intraoperative total doses of remifentanil, pentothal, desflurane consumption
Measured: During operation time
Extubation and recovery time
Using modified aldrete score
Measured: Through surgical operation completion
Pain assessed by NRS
Numeric rating scale (NRS) at rest and in motion will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Measured: 24 hours
Degree of sedation
Ramsay Sedation Scale (RSS) will be used to assess degree of sedation. The RSS was designed as a test of arousability. The RSS scores sedation at six different levels, according to how arousable the patient is. The RSS defines the conscious state from a level 1: the patient is anxious, agitated or restless, through the continuum of sedation to a level 6: the patient is completely unresponsive.
Measured: 24 hours
Rate of opioid related side effects
Opioid related side effects such as nause/vomiting, pruritis, bradycardia, hypotension will be evaluated at intervals up to 24 hours.
Measured: 24 hours
Supplemental and rescue analgesic requirement
Total supplemental and rescue analgesic consumption
Measured: 24 hours
Patient satisfaction assessment
It will be assessed with patient satisfaction scale classified as 'excellent': no pain, NRS=0; 'good': very mild pain, NRS=1-2; 'moderate': mild pain, NRS=3-4.
Measured: At the postoperative 24th hour
Bilateral shoulder mobility
It will be assessed with ability of shoulder abduction degree
Measured: Preoperative and postoperative 4th, 8th, 12th, and 24th hours
Length of stay in hospital
Duration of length of stay in hospital will be recorded
Measured: Until discharge from hospital, up to 7 days postoperatively
Rate of block related complications
Rate of block related complications such as hematoma, nerve deficit, pneumothorax etc. will be recoded.
Measured: Until discharge from hospital, up to 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start15 Aug 2018
- Primary completion15 Aug 2021
- Study completion1 Sep 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.
- 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 N/A
- 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, Demet Laflı Tunay, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03621345
- Sponsor's protocol ID
- CukurovaUniv
- Status last verified
- Feb 2023
- First submitted
- 27 Jul 2018
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tunay DL, Ilginel MT, Karacaer F, Biricik E, Tabakan I, Ozmete O. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Perioperative Analgesia in Breast Reduction Surgery: A Prospective Randomized and Controlled Trial. Aesthetic Plast Surg. 2023 Aug;47(4):1279-1288. doi: 10.1007/s00266-023-03315-0. Epub 2023 Mar 16.
PubMed 36928313
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery: A Prospective, Randomized and Controlled Trial
- ClinicalTrials.gov ID
- NCT03621345
- Acronym / sponsor ID
- CukurovaUniv
- Conditions
- Postoperative Pain, Breast Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 8 Aug 2018 (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.
Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESP block group | Active comparator | Procedure: Erector spinae plane blockThe bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain. Interventions: Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization |
| sham block | Sham comparator | Other: sham blockA sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied. Intervention: Sham block Other: Standard Pain Followup and Monitorization |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery
Key exclusion criteria (8 listed)
- Coagulopathy
- Allergy to amide-type local anesthetics
- Infection at the ESP block injection site
- Severe obesity (BMI > 35 kg/m2)
- Liver or renal deficiency
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 blockUltrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients. | Procedure or surgery | ESP block group |
| sham blockA sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients. | Other | sham block |
Primary outcome
Postoperative morphine consumption
Time frame: 24 hours
Morphine consumption in Patient Controlled Analgesia device
10 secondary outcomes
Intraoperative anesthetic consumption
Time frame: During operation time
Extubation and recovery time
Time frame: Through surgical operation completion
Pain assessed by NRS
Time frame: 24 hours
Degree of sedation
Time frame: 24 hours
Rate of opioid related side effects
Time frame: 24 hours
Supplemental and rescue analgesic requirement
Time frame: 24 hours
Patient satisfaction assessment
Time frame: At the postoperative 24th hour
Bilateral shoulder mobility
Time frame: Preoperative and postoperative 4th, 8th, 12th, and 24th hours
Length of stay in hospital
Time frame: Until discharge from hospital, up to 7 days postoperatively
Rate of block related complications
Time frame: Until discharge from hospital, up to 7 days 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 10 Feb 2023.
- Derived from this study: PubMed 36928313Tunay DL, Ilginel MT, Karacaer F, Biricik E, Tabakan I, Ozmete O. Bilateral Ultrasound-Guided Erector Spinae Plane Block for Perioperative Analgesia in Breast Reduction Surgery: A Prospective Randomized and Controlled Trial. Aesthetic Plast Surg. 2023 Aug;47(4):1279-1288. doi: 10.1007/s00266-023-03315-0. Epub 2023 Mar 16.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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 Erector spinae plane block in people with Postoperative Pain and Breast Hypertrophy, 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 1 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 10 Feb 2023. 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. Some participants in this study may receive a placebo. 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?
Postoperative morphine consumption (time frame: 24 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 NCT03621345, 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 10 Feb 2023.