Erector Spinae Block in Segmental Mastectomy.

Breast Cancer Clinical Trial

Official title:

Evaluation of the Analgesic Efficacy of Ultrasound-guided Erector Spinae Block in Unilateral Breast Cancer Surgery: Randomized Controled Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03509090
• Other study ID #: 17-AKD-186
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: May 2019

Study information

• Verified date: March 2019
• Source: Maltepe University
• Contact: Onur Selvi, Dr
• Phone: 02164440620
• Email: prostel[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Erector spinae plane block (ESPB) is a recently described block. Although there is still no consensus of its mechanism, the published case series seems to promise a new regional anesthesia technique for both chronic and acute pain. In this clinical trial, the postoperative analgesic effect of ESPB will be studied in patients underwent unilateral breast cancer surgery.

Description:

In this study 30 patients will be enrolled to study between March 2018-August 2018. All patient will be randomly selected who will be operated for breast cancer surgery between determined dates. Age, weight, ASA score, body mass index , additional dissease ststus will be recorded. The patients will be divided in two groups. One group will have ESPB at the end of the operation and the second group will be treated with multimodal analgesia techniques and both groups will receive patient controlled analgesia. Both groups will receive identical anaethesia protocols. Perioperative analgesia protocols will provide acetaminophen 1 gr and the same dose will be repeated in every 6 hours regardless of the pain scores. In postoperative period the pain scores of the patients will be recorded according to the numeric rating scale (NRS) in every three hours. If pain score raises over 4/10 on NRS the patient will receive tramadol 100mg as rescue analgesia. In case of persisting pain first, meperidine 50 mg will be apllied and other multimodal analgesic drugs will be added to protocol. At the end of the study 24 hours total opioid usage of patients, pain scores and side effects will statistically be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Being volunteer

2. Over 18 years old

3. Unilateral segmental mastectomy patients

Exclusion Criteria:

1. Emergency operations

2. Younger than 18 years old,

3. Non Volunteers

4. ASA 3 and 4 patients

5. Non-cooperative patients

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• erector spinae block
erector spinae block will be performed in this group as postoperative analgesia treatment.
• Control group
patients will receive only multimodal analgesic treatment including patient-controlled analgesia

Locations

Country	Name	City	State
Turkey	Maltepe University Medical Faculty	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Maltepe University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. — View Citation

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative anaglesic effect of ESPB in unilateral segmental mastectomy patients	Post operative pain scores will be recorded with NRS and opioid usage will be recorded	24 hours postoperatively