Comparison of efficacy of two different techniques of Ultrasound guided local anesthetic druginjections for postoperative pain relief in radical breast surgeries.

Completed

• Conditions: Malignant neoplasm of breast,

• Registration Number: CTRI/2021/12/038627
• Lead Sponsor: AIIMS

Brief Summary

Breast cancer is increasingly becoming the most common cancer among females worldwide.Modified radical mastectomy(MRM) is a common surgical procedure being performed for patients with breast cancer.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing oncosurgical procedures.The optimal use of analgesic technique provides both short term benefits like adequate pain management,reduced postoperative nausea and vomiting,improved quality of surgical recovery and long term benefits like reduced risk of development of chronic postsurgical pain and development of metastases and recurrent disease.A number of regional anesthetic techniques like local wound infiltration,thoracic epidural anesthesia and thoracic paravertebral block and more recently fascial blocks have been employed for perioperative pain in patients undergoing breast cancer surgeries.The fascial blocks include classical and modified Pectoralis nerve block(PECS),Serratus anterior plane(SAP) and Erector spinae plane block(ESPB).The pectoral nerve block is an easy and safe nerve block for breast surgery.But it does not sufficiently block the anterior branches of the intercostal nerves (from T2 to T6) or the lateral branches of the intercostal nerves (from T5 to T6); therefore, postoperative analgesia of the internal and inferior mammary area may be insufficient. Complete Antethoracic block blocks these spared anterior and lateral branches of intercostal nerves too,hence better analgesia of the breast is provided.There is a case report on analgesic effect of complete antethoracic block,but it has not been compared with paravertebral block to compare its analgesic efficacy previously.Hence,with the above background, we planned a prospective randomized clinical trial to compare the analgesic efficacy of single level thoracic paravertebral block and complete antethoracic block in patients undergoing modified radical mastectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-16
• Study Completion: 2022-03-15
• Last Update Posted: 2024-12-25

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• ASA I and II 2.
• Patients posted for MRM 3.
• Patients giving written informed consent to participate in the study.

Exclusion Criteria

• BMI > 35kg/m2 2.
• Patient with infection at the site of injection 3.
• Coagulopathy 4.
• Spine deformity 5.
• Drug addicts or history of opioid dependence 6.
• Patients with history of allergy to opioids or local anaesthetics.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To measure the duration of Post-operative	Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period
analgesia (that is, time to first rescue analgesia	Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period
after administration of block ).	Post-operative (0 | min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period

Secondary Outcome Measures

Name	Time	Method
Total rescue analgesic requirement in	Post-operative period.
Comparison of Post-operative pain ( using numeric rating scale) and adverse effects	Post-operative (0
To evaluate and compare patient satisfaction with the block	procedure and at the end of 24hours in postoperative period.

Trial Locations

Locations (1)

AIIMS; 🇮🇳 Delhi, DELHI, India

AIIMS

🇮🇳Delhi, DELHI, India

Dr Sachidanand Jee Bharti

Principal investigator

9968436042

sachidadr@yahoo.co.in