A study to compare the efficacy of ultrasound guided erector spinae block versus serratus plane block in breast cancer surgery.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2021/08/035542
- Lead Sponsor
- Institute of Medical Sciences Banaras Hindu University Varanasi
- Brief Summary
Breast surgery is one of the most common surgeries due to high incidence of breast cancer. Modified radical mastectomy (MRM) is one the commonly performed breast surgery. The effective pain relief is the utmost important in treating patients who are undergoing surgery. This study compares the analgesic efficacy of ultrasound guided erector spinae plane block(ESPB) and serratus anterior plane block (SAPB) in patients undergoing unilateral modified radical mastectomy (MRM).
This randomized prospective study will be carried out on 40 ASA I and II patients of age group of 18-65 years of either sex undergoing unilateral modified radical mastectomy with 20 patients in each group who will be randomly allocated by sealed envelope method.
After the approval by the Institutional Ethical Committee, written informed consent will be obtained from all the patient before being included in the study. They will be allocated to 2 groups by randomization.
Group ESPB - Patients will be administered ultrasound guided erector spinae block.
Group SAPB - Patients will be administered ultrasound guided serratus plane block.
The duration of analgesia of the block will be observed in both the groups which will be the time from administration of block to the first use of rescue analgesic.
Also, in both the groups, patients will be observed for intra-operative and post-operative hemodynamic changes, intra-operative opioid & post-operative analgesic consumption, visual analogue scale (VAS) pain scores and adverse effects of the two blocks .
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- Patients belonging to American Society Of Anesthesiologists (ASA) classification I & II status.
- Patients undergoing unilateral modified radical mastectomy.
- Hemodynamically stable.
- Patient refusal.
- Patient having history of known allergies to any of the study drugs.
- Infection at the puncture site of proposed block.
- Patients with deranged coagulation and bleeding parameters (INR>1.5).
- Patients with history of receiving anticoagulant treatment.
- Presence of pregnancy or lactation.
- Patients with cognitive or communicative impairment.
- Patients having history of chronic opioid consumption.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of analgesia of the block. The duration of analgesia will be the time from administration of block to the first use of rescue analgesic. | Post-operative:1hour,2hours,4hours,8hours,12hours,18hours,24hours.
- Secondary Outcome Measures
Name Time Method Intra-operative and post-operative haemodynamic changes, intra-operative opioid & post-operative analgesic consumption, visual analogue scale (VAS) pain scores and adverse effects of the two blocks for modified radical mastectomy. Intra-operative:5minutes,15minutes, 30minutes,60minutes,90minutes,120minutes.
Trial Locations
- Locations (1)
Sir Sundarlal Hospital
🇮🇳Varanasi, UTTAR PRADESH, India
Sir Sundarlal Hospital🇮🇳Varanasi, UTTAR PRADESH, IndiaDr Saurabh SagarPrincipal investigator7676230522dr.saurabhsagar@gmail.com