Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery.

Study Overview
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Brief Summary
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Breast cancer is the most common and leading cause of cancer deaths among females worldwide. Patients undergoing modified radical mastectomy (MRM) are associated with moderate to severe acute postoperative pain and shoulder mobility restriction. This study aims to determine the effectiveness of ultrasound-guided PECS block for reducing opioid consumption, providing adequate postoperative pain management and improving patient satisfaction following breast cancer surgery.

Detailed Description
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The traditional pain management for patients undergoing MRM has relied heavily on opioids but a number of multimodal pain control strategies also exist including combining opioids with NSAIDs, cyclooxygenase-2 inhibitors, acetaminophen and regional blocks. Recently, literature underlines the importance of performing regional anaesthetic and analgesic techniques for postoperative analgesia following breast surgery. PECS (Pectoral nerve block) block provides analgesia for breast surgeries with few adverse effects. OBJECTIVES To evaluate the effect of ultrasound guided pectoral block in reducing intraoperative and postoperative opioid consumption following modified radical mastectomy. The secondary objective is to determine patient satisfaction levels associated with adequate pain control. HYPOTHESIS Pectoral nerve blocks provides superior analgesia with less opioid consumption and improves patient satisfaction in postoperative period compared to conventional pain management for modified radical mastectomy patients

Official Title
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Effectiveness of Ultrasound Guided PECS Block on Opioid Consumption and Patient Satisfaction Through Adequate Pain Control Following Breast Cancer Surgery. A Prospective Randomized Controlled Trial

Conditions
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Pain, Breast Neoplasm Female, Pain, Postoperative, Analgesia, Anaesthesia, Breast Cancer

Intervention / Treatment
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* Procedure: PECS Block
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective modified radical mastectomy (MRM) All adults aged between 18 and 65 years ASA (American Society of Anesthesiologists ) I & II Exclusion Criteria: Patient refusal Hypersensitivity to local anaesthetics Coagulopathy or bleeding diathesis Local infection at the site of block BMI more than 35 kg/m2 Chest wall deformity or previous breast surgery MRM with latissimus dorsi or deep inferior epigastric perforator flap reconstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PECS block<br>For patients in PECS group (PG), after induction of general anesthesia, the nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given. | Procedure: PECS Block<br>* PECS nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.<br>|
| Active Comparator: Control Group<br>For patients in control group, after induction of general anesthesia, no nerve block will be performed and only intravenous nalbuphine will be given. | Other: Control Group<br>* No nerve block will be performed and only intravenous nalbuphine will be given.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total intraoperative opioid consumption | Total intraoperative nalbuphine | During surgical procedure | 
| Total postoperative opioid consumption | Total Rescue Tramadol Consumption | First 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.: = Not Satisfied = Good or satisfied = Excellent or very satisfied | First 24 hours after surgery | 
| Postoperative pain score | Numeric rating scale for pain assessment: Patient will be asked to rate their intensity of pain on numeric scale from 0 (no pain) to 10 (worst possible pain). | 1, 6,12 and 24 hours after surgery | 
| Postoperative nausea and vomiting | Yes or No | First 24 hours after surgery |