To compare the effectiveness of pectoral nerve block and erector spinae nerve plane block in improvement of pain scores after breast cancer surgery.

Phase 2/3

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/08/056620
• Lead Sponsor: Sri Guru Ram Das Institute of Medical Sciences and Research

Brief Summary

BACKGROUND- Cancer breast is one of the most common causes of morbidity and mortality in females. According to National Cancer Registry, it accounts for 25-32% of all female cancers in India. Thirty one percent of the breast surgeries performed are Modified Radical Mastectomy (MRM). It is commonly performed under general anaesthesia and has been often associated with postoperative pain, nausea and vomiting; thus, causing increased patient suffering. Postoperative pain after breast cancer surgery is extremely debilitating and has been shown to be associated with severe morbidity as well as delay in recovery time. To manage this problem usually paravertebral blocks or thoracic epidurals were used but they are associated with various complications such as pneumothorax, vascular puncture, nerve damage. With the advent of ultrasound, pectoral nerve blocks (PEC) and erector spinae plane blocks (ESP) are now being performed routinely. They are considered quite effective for postoperative pain relief. But the data available for comparison of the two is limited.  So, we hereby intend to compare the two latest modalities, when used along with GA for breast surgeries, i.e. the PEC block and the ESP block.

OBJECTIVE- To compare the efficacy of pectoral nerve block and erector spinae plane block in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics in carcinoma breast patients undergoing modified radical mastectomy under general anaesthesia.

MATERIALS AND METHODS- In three groups of 36 each, randomly selected patient, either ultrasound guided PEC block with 30ml of 0.25% levobupivacaine or ESP block with 30 ml of 0.25% levobupivacaine will be given along with GA . These two techniques will be compared with sham procedure performed with GA.

EXPECTED BENEFITS- Reduction in intra-operative anaesthesia requirement, stable hemodynamics, opioid sparing effect, reduced post-operative pain, reduction in requirement of opioid analgesia during post-operative period.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-08-17
• Study Start: 2023-08-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

Scheduled for unilateral elective carcinoma breast surgeries.

Exclusion Criteria

• Patients having skin infections at the needle puncture site.
• Patients suffering from coagulopathies/bleeding disorders.
• Patient with chest wall/spine deformities.
• Patients with BMI>35kg/m2.
• Patients with a past history of neuropathies.
• Pregnant patients.
• Patients hypersensitive to the drugs being used in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the efficacy of pectoral nerve block, erector spinae plane block	Till 24 hours of block

Secondary Outcome Measures

Name	Time	Method
A) To study the efficacy of PEC block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score & the number of rescue analgesics. B) To study the efficacy of ESP block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and the number of rescue analgesics. C) To study the sham block with GA in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics. D) To compare the efficacy of PEC and ESP block in terms of intra-operative requirement of anaesthetic drugs, hemodynamics, duration of analgesia, VAS score and number of rescue analgesics to sham block.

Trial Locations

Locations (1)

Sri Guru Ram Das Institute of Medical Sciences and Research; 🇮🇳 Amritsar, PUNJAB, India

Sri Guru Ram Das Institute of Medical Sciences and Research

🇮🇳Amritsar, PUNJAB, India

Dr Ruchi Gupta

Principal investigator

9810420805

drruchisgrd@gmail.com