To compare the effect of depositing drug below erector spinae and rhomboid muscles using ultrasound in relieving pain after breast cancer surgery

Completed

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2021/03/031983
• Lead Sponsor: AIIMS PATNA

Brief Summary

**Introduction:**

Breast cancer is the one of the most frequently diagnosed cancers among women in the world. It is overall the second most common cancer in the world. Now it has  become the most common cancer among women in the developing world.1 Treatment modality for breast cancer includes  primarily surgery (mastectomy), with or without chemotherapy, and/or radiotherapy  but severe acute postoperative pain is a high concern for approximately half of all breast surgery patients.2 For a long time, various regional anesthesia techniques including thoracic paravertebral block, Erector spinae plane block, Pecs block etc has been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect.

Following endotracheal intubation, patients in the group A will be positioned in lateral decubitus with the involved breast lying superiorly. The spine will be palpated from C7 (most prominent spinous process) to T5 and point will be marked to identify the spinous process. Ultrasound-guided EPSB will be performed by Paramedian sagittal scan with in-plane needle insertion from cranial to caudal.

Following endotracheal intubation, patients in the group B will be positioned in lateral decubitus with the involved breast lying superiorly. The ipsilateral arm will be moved across the chest to move the scapula away and open up the triangle of auscultation (TOA) space (Figure 2). The TOA is located along the lower medial border of the scapula. It is bounded superiorly by the trapezius, inferiorly by the latissimus dorsi, and laterally by the vertebral border of the scapula. Rhomboid intercostal block will be performed aseptically by an anaesthesiologist experienced with the performance of RIB.

·         **Problem statement**:

Breast cancer surgery is associated with acute and chronic postoperative pain which is a significant concern. Inadequate postoperative pain control may hamper early recovery and discharge. High dose of opioid consumption for perioperative analgesia in breast cancer surgery increases PONV, tolerance and respiratory depression and may delay recovery. Therefore, effective and safe multimodal analgesia is required to control postoperative acute pain and reduce opioid consumption.

·         **Rationale**–

Ultrasound guided ESPB and RIB are effective, safe and new regional block techniques for  postoperative analgesia to control acute postoperative pain which help in early recovery and patient satisfaction which is a significant concern in breast cancer surgery. Both reduce postoperative opioid consumption and their side effects. But it is not known which among the two has better analgesic efficacy.

·         **Novelty** -

Currently many regional block techniques are in practice for perioperative analgesia in breast cancer surgery but none of them can be considered as gold standard. Ultrasound guided ESPB and RIB are relatively new  and safe regional blocks for major thoracic surgery. This study is one of its kind in which we will compare perioperative analgesic efficacy of the two blocks.

·         **Research question:**  Does ultrasound guided ESPB provide more effective perioperative analgesia   than RIB in breast cancer surgery?

·         **Research hypothesis**: Ultrasound guided ESPB provides more effective perioperative analgesia than RIB in breast cancer surgery.

·         **Aim –** To compare ultrasound guided Erector spinae plane block versus Rhomboid intercostal block for perioperative analgesia in breast cancer surgery.

·         **Primary Objective:**

To compare opioid consumption between ultrasound guided ESPB versus RIB for perioperative analgesia in breast cancer surgery.

·         **Secondary Objective :**

1.      To compare the time to first rescue analgesia.

2.      To compare postoperative pain score at 0,1,2,4,6,12 and 24 h.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Study Completion: 2022-07-30
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 76

Inclusion Criteria

• 1.Female with breast cancer undergoing unilateral Modified Radical Mastectomy (MRM) or Breast conservative surgery with sentinel lymph node dissection.
• 2.American society of anesthesiologist (ASA) physical status Ç€ and Ç.
• 3.BMI 18-24.9 kg/m2.

Exclusion Criteria

1.Patients with coagulation disorder 2.Chronic opioid use 3.Allergy to local anaesthetic 4.Procedure site infection 5.History of previous mastectomy 6.Severe spine/chest wall deformity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Perioperative opioid consumption	From administer of the regional block to 24 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
1.Time of first rescue analgesia	2.NRS Pain score

Trial Locations

Locations (1)

AIIMS PATNA; 🇮🇳 Patna, BIHAR, India

AIIMS PATNA

🇮🇳Patna, BIHAR, India

Dr Satish Kumar

Principal investigator

8210014760

satish.psc@gmail.com