Different Volumes of Erector Spinae Plane Block for Breast Surgery

NCT05232084 | Completed

• 1 other identifier: Medipol Hospital 26
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

Conditions

Breast Cancer; Breast Neoplasms; Breast Diseases

Keywords

Mastectomy and axillary dissection surgery; Postoperative pain management; Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (1)

• Postoperative opioid consumption (need and demand as microgram)

  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 Outcomes (1)

• Pain scores (Visual analogue scores-VAS)

  Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours

Study Arms (2)

Group 30 = 30 ml of Erector spinae plane block group

ACTIVE COMPARATOR

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.

Drug: Bupivacaine + Fentanyl

Group 20 = 20 ml of Erector spinae plane block group

ACTIVE COMPARATOR

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.

Drug: Bupivacaine + Fentanyl

Interventions

Bupivacaine + Fentanyl DRUG

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.

Group 20 = 20 ml of Erector spinae plane block group; Group 30 = 30 ml of Erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients who will undergo breast surgery will be included
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification I-II
• Scheduled for mastectomy and axillary dissection surgery under general anesthesia

You may not qualify if:

• anticoagulant treatment,
• known local anesthetic allergy,
• infected skin around the block site,
• pregnancy or breast-feeding,
• back abnormalities

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Istanbul Medipol University Hospital

Istanbul, Bagcilar, 34070, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 31280100 BACKGROUND

• 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.

  PMID: 30832580 BACKGROUND

• 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.

  PMID: 32696226 BACKGROUND

• 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.

  PMID: 32317873 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 9, 2022
• Study Start: January 27, 2022
• Primary Completion: May 20, 2023
• Study Completion: May 25, 2023
• Last Updated: May 30, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)