Comparison of Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Surgery

Postoperative Pain Clinical Trial

Official title:

Comparison of Postoperative Efficacy of Ultrasound-guided Bi-level Erector Spine Plane Block and Combined Pectoral I-II Block in Breast Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689581
• Other study ID #: KOU KAEK 2018/487
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: June 2021
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, we compared ultrasound-guided modified pectoral nerve (PECS) block and bi level erector spinae plane (ESP) block on postoperative analgesic effect in breast surgery.

Description:

After being informed about the study and potential risks, written consent was obtained from all patients. Patients who meet eligibility requirements will be randomized in a 1:1 ratio to bi- level erector spinae plane block and modified pectoral block.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 15, 2021
• Est. primary completion date: January 10, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Classification (ASA) I-II patients

• 18-70 aged patients

• patients who scheuled elective breast cancer surgery

Exclusion Criteria:

• American Society of Anesthesiologists Classification (ASA) III-IV patients

• patients with coagulopathy

• patients with infection at the injection site

Related Conditions & MeSH terms

• Analgesia
• Pain, Postoperative
• Postoperative Pain

Intervention

Other:
• Ultrasound guided bi-level erector spinae plane block
Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.
• Ultrasound guided modified pectoral nerve block
Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.

Locations

Country	Name	City	State
Turkey	Kocaeli University	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphin consumption	Patients in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.	during postoperative 24 hour
Primary	numerical rating scale (NRS)	A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable	during postoperative 24 hour

External Links

•   Efficacy of erector spinae plane block for analgesia in breast surgery: a systematic review and meta-analysis