- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05232084
Different Volumes of Erector Spinae Plane Block for Breast Surgery
Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.
The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.
The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Bidak, MD
Study Locations
-
-
Bagcilar
-
Istanbul, Bagcilar, Turkey, 34070
- Istanbul Medipol University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) classification I-II
- Scheduled for mastectomy and axillary dissection surgery under general anesthesia
Exclusion Criteria:
- anticoagulant treatment,
- known local anesthetic allergy,
- infected skin around the block site,
- pregnancy or breast-feeding,
- back abnormalities
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group 30 = 30 ml of Erector spinae plane block group
In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up.
US probe will be placed 2-3 cm lateral to the T4 transvers process.
The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia.
Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
|
Active Comparator: Group 20 = 20 ml of Erector spinae plane block group
In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up.
US probe will be placed 2-3 cm lateral to the T4 transvers process.
The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia.
Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.
|
Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.
A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative opioid consumption (need and demand as microgram)
Time Frame: Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device. The parameters on PCA devices such as delivery and demand will be assessed |
Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain scores (Visual analogue scores-VAS)
Time Frame: Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt).
The VAS scores will be recorded
|
Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gurkan Y, Aksu C, Kus A, Yorukoglu UH. Erector spinae plane block and thoracic paravertebral block for breast surgery compared to IV-morphine: A randomized controlled trial. J Clin Anesth. 2020 Feb;59:84-88. doi: 10.1016/j.jclinane.2019.06.036. Epub 2019 Jul 4.
- Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3.
- Uda Y, Byrne K, Brahmbhatt A, Gotmaker R, Lim D, Konishi Y, Eves TK, Paxton E, Barrington MJ. A pilot randomized-controlled trial evaluating the erector spinae plane block in thoracic and breast surgery. Can J Anaesth. 2020 Oct;67(10):1371-1380. doi: 10.1007/s12630-020-01759-5. Epub 2020 Jul 21.
- Sharma S, Arora S, Jafra A, Singh G. Efficacy of erector spinae plane block for postoperative analgesia in total mastectomy and axillary clearance: A randomized controlled trial. Saudi J Anaesth. 2020 Apr-Jun;14(2):186-191. doi: 10.4103/sja.SJA_625_19. Epub 2020 Mar 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Neoplasms
- Breast Diseases
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Fentanyl
- Bupivacaine
Other Study ID Numbers
- Medipol Hospital 26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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