Different Volumes of Erector Spinae Plane Block for Breast Surgery

Sponsor

Medipol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05232084

Collaborator

(none)

Enrollment

Location

Arms

7.1

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Neoplasms Breast Diseases	Drug: Bupivacaine + Fentanyl	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group

Primary Purpose:

Treatment

Official Title:

Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study

Actual Study Start Date :

Jan 27, 2022

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

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.	Drug: Bupivacaine + Fentanyl 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.	Drug: Bupivacaine + Fentanyl 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.

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.

Drug: Bupivacaine + Fentanyl

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.

Drug: Bupivacaine + Fentanyl

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption (need and demand as microgram) [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

Secondary Outcome Measures

Pain scores (Visual analogue scores-VAS) [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University Hospital	Istanbul	Bagcilar	Turkey	34070

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bahadir Ciftci, Principal Investigator, Medipol University

ClinicalTrials.gov Identifier:

NCT05232084

Other Study ID Numbers:

Medipol Hospital 26

First Posted:

Feb 9, 2022

Last Update Posted:

Aug 2, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bahadir Ciftci, Principal Investigator, Medipol University

Mastectomy and axillary dissection surgery

Postoperative pain management

Erector Spinae Plane Block

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 2, 2022