Comparison of two different ultrasound guided blocks for breast surgeries

Not yet recruiting

Conditions: Benign neoplasm of unspecified breast, (2) ICD-10 Condition: M728||Other fibroblastic disorders,

Registration Number: CTRI/2021/03/031811

Lead Sponsor: S Nijalingappa medical college and HSK hospital hospital

Brief Summary: Ultrasound guided inter fascial plane blocks such as pectoral nerve(PECS) block, serratus anterior plane block(SAP) and erector spinae plane block(ESP) which is a recent block newly described for various surgeries for postoperative analgesia have also been reported as alternatives, with advantages of simplicity, ease of performance and fewer complications.There are no sufficient randomized controlled trails that assess the effectiveness and safety of erector spinae plane block and serratus anterior plane block.

**Primary objective**: To compare the duration of postoperative analgesia following ultrasound guided erector spinae plane block and serratus anterior plane block in breast surgeries using visual analogue scale (VAS) **Secondary objectives: 1.** Time taken to first opioid analgesia in post anaesthetic care **2.** Total postoperative opioid consumption in 24hrs.

The patients participating in this study will be randomly grouped into group A and group B. Random allocation into these groups will be done by computer generated random numbers. For Group A patients erector spinae (ESP) block will be given and for Group B patients Serratus Anterior plane (SAP) block will be given for post-operative analgesia. Investigators involved in data collection will also be masked to the patients group allocation and did not have any access to the randomization until data analysis was complete. Therefore, this study has a double blind design. After shifting the patients to OT, intravenous cannula of appropriate size will be secured and IV fluid ringer lactate will be started. Pulse rate ,noninvasive blood pressure, saturation of oxygen, ECG will be monitored. All patients will receive same anaesthesia and analgesia protocol. Post-operative pain assessment will be done using Visual Analogue Scale (VAS) during 1st, 2nd, 4th, 6th, 8th, 10th, 12th & 24 hours.

The pain VAS is considered as a unidimensional measure of pain intensity in adults. The intensity of postoperative pain is recorded for all patients using VAS score (0 is no pain and 10 is worst possible pain). Using a ruler, the score is determined by measuring the distance on the 10cm line between the no pain anchor and the patients mark, providing a range of scores from 0 to 10. A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in post operative patients, the following cutoffpoints on VAS have been recommended.

0 No pain

1 to 3 cm Mild pain

4 to 6 cm Moderate pain

7 to 10 cm Severe pain

Average time duration to administer first postoperative analgesia ( rescue analgesia) is noted. Rescue analgesia (Tramadol iv50mg) is considered when VAS more than 4.

Vitals will be monitored and maintained throughout the surgery.

Both erector spinae plane block & serratus anterior plane blocks performed under ultrasound guidance significantly reduce the VAS pain score and analgesic requirement for up to 24 hours without any major complications. Further the study is going to establish that erector spinae plane block might be more effective than serratus anterior plane block in post-operative analgesia and it can further improve quality of multimodal analgesia during post-operative period.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

1.ASA I-II 2.Patients aged between 18-80years 3.Patients undergoing elective breast surgery.

Exclusion Criteria

1.Refusal at enrollment 2.Patients with coagulation system disorders 3.Patients with raised intracranial tension 4.Patients with hepatic/renal failure 5.Chronic use of opioids or corticosteroids 6.Patients allergic to local anesthetics.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Erector spinae plane block may be superior than serratus anterior plane block in providing postop analgesia	24 hours

Secondary Outcome Measures

Name	Time	Method
Total amount of opioid consumption	24 hours

Trial Locations

Locations (1): Major OT complex,
🇮🇳
Bagalkot, KARNATAKA, India
Major OT complex,
🇮🇳Bagalkot, KARNATAKA, India
Dr Ramesh Koppal
Principal investigator
9845504515
rameshkoppaldr@gmail.com