To compare the effect of erector spinae block under sedation and general anesthesia on postopertaive recovery in patients undergoing breast brachytherapy

Recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2019/06/019579
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Breast cancer is aworldwide problem, accounting for 10.4% of all cancer incidence among women,making it the second most common type of non-skin cancer (after lung cancer)and the fifth most common cause of cancer death. The ‘surveillance, epidemiology andend results’ (SEER) program reported that in 2006, 60% of diagnosed breastcancers are early stage. The management of early-stagebreast cancer includes  breast-conservingsurgery (such as lumpectomy), a mastectomy (also called a modified radicalmastectomy), radiation therapy and systemic treatments.

Despite theadvantages of BCT, its utilization remains a problem due to convenience, access, cost and other logistical issues. In APBI, radiation can bedelivered in a significantly shortened period, thereby potentially making theBCT option available and attractive to more women. APBI can be done undereither local anaesthesia, general anaesthesia or regional blocks with sedation.Breast cancer surgery, such as mastectomy or lumpectomy with or withoutaxillary lymph node dissection/biopsy, has frequently been performed usinggeneral anesthesia (GA). However, GA is associated with a high incidence of postoperativenausea and vomiting (PONV) that not only reduces patient satisfaction but alsodelays patient recovery after breast surgery. Recently,breast cancer surgery has often been performed under regional anesthesiatechniques like Paravertebral block (PVB), erector spinae block etc.   Arecent metaanalysis demonstrated that thoracic PVB has several advantages, suchas better postoperative pain control, lower incidence of PONV, shorter recoverytime and higher patient satisfaction, compared with GA alone in breast surgery.  To our knowledge, however, there are no reports of studies comparing GA withErector Spinae block for Accelerated Partial Breast Irradiation. The firstpurpose of this study is to   compare these two anesthesia techniques interms of post-anesthesia recovery time. Our  secondary aim was to compare perioperativehemodynamics because decreasing blood pressure is often observed during GA. Wehypothesized that performing the procedure under  Erector Spinae block could facilitate postoperativerecovery and avoid hypotension during anesthesia.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-06
• Last Update Posted: 2021-09-06

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of early stage breast cancer for APBI.
• ASA Physical status I, II, III.

Exclusion Criteria

• Patients Refusal b.
• Patients with infection at the site of ESPB.
• Patients with severe chest wall deformity.
• Patients with history suggestive of coagulopathy or receiving any anticoagulants.
• Presence of complications like mental illness, severe heart disease (NYHA classification ≥3), any renal or hepatic disorder before surgery.
• Allergic to any drug being used during the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Discharge from PACU as assessed by PADSS more than equal to 9 after end of surgery.	Discharge from PACU as assessed by PADSS more than equal to 9 at regular intervals time 0,1,2,4 hrs.

Secondary Outcome Measures

Name	Time	Method
Postoperative pain VAS score	Postoperative Nausea vomiting( VAS score 30 mm)

Trial Locations

Locations (1)

Department of Onco-Anesthesiology and Palliative Medicine; 🇮🇳 South, DELHI, India

Department of Onco-Anesthesiology and Palliative Medicine

🇮🇳South, DELHI, India

Nishkarsh Gupta

Principal investigator

9013310014

drnishkarsh@rediffmail.com