Anaesthesia, Analgesia, Breast Cancer, Breast Neoplasm Female, Pain, Pain, Postoperative
Conditions
Brief summary
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
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
Interventions
PROCEDUREPECS Block
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 The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be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.
OTHERControl Group
No nerve block will be performed and only intravenous nalbuphine will be given.
Sponsors
Aga Khan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total intraoperative opioid consumption | During surgical procedure | Total intraoperative nalbuphine |
| Total postoperative opioid consumption | First 24 hours after surgery | Total Rescue Tramadol Consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | First 24 hours after surgery | Patient satisfaction with post-operative analgesia will be noted via satisfaction scoring i.e.: 1. = Not Satisfied 2. = Good or satisfied 3. = Excellent or very satisfied |
| Postoperative pain score | 1, 6,12 and 24 hours after surgery | 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). |
| Postoperative nausea and vomiting | First 24 hours after surgery | Yes or No |
Countries
Pakistan
Outcome results
None listed