Effect of Erector Spinae Plane Block Versus Local Wound Infiltration on Postoperative Pain After Modified Radical Mastectomy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tanta University
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- total morphine consumption
Study Overview
Brief Summary
This randomized prospective double blinded study will aim to evaluate the postoperative analgesic effect of ultrasound guided Erector Spinae plane block and local wound infiltration (drain block) for patients scheduled for modified radical mastectomy surgery.
Detailed Description
Breast cancer is the most commonly diagnosed cancer worldwide and it represents 1 in 4 cancers diagnosed among women globally. Modified Radical Mastectomy (MRM) is a commonly performed surgery for breast cancer and is associated with moderate-to-severe postoperative pain. Poor postoperative pain management can lead to increased chances of the development of chronic pain. Therefore, adequate postoperative pain management after breast cancer surgery is essential. Regional block for pain management has many advantages in such patients including provision of adequate analgesia, reduced need for opioids, decreased postoperative nausea & vomiting and postoperative pulmonary complications. It also facilitates early ambulation. Thoracic Epidural (TE), paravertebral block (PVB), pectoral nerve I & pectoral nerve II blocks, serratus anterior plane block and erector spinae plan block have been used with good results. In particular, the erector spinae has proven to reduce pain severity and opioid consumption in this group of patients. Further, in meta-analysis, the ESP block was shown to effectively alleviate postoperative pain severity and reduce opioid consumption. In ESP block, local anesthetic is deposited deep to the erector spinae muscle which results in blocking of the ventral and dorsal rami of multiple spinal nerves. The LA diffuses into the paravertebral space and cephalo-caudally and blocks the pain by action on dorsal rami, ventral rami, and lateral cutaneous branches of intercostal nerves. Also, in many situations, a superior postoperative analgesia yet avoiding the detrimental effects of opioids, can be extracted from a simple technique of wound instillation of local anesthetics through surgical drain which provide a satisfactory long opioid free postoperative analgesic period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiology (ASA) physical status I-II
- •scheduled for unilateral Modified radical mastectomy
Exclusion Criteria
- •Patient refusal.
- •Patient with neurological deficit.
- •Patient with bleeding disorders.
- •Uncooperative patient.
- •Infection at the block injection site.
- •Patients with history of allergy to local anesthetics.
- •Advanced hepatic, cardiac or renal failure.
- •Chronic opioid consumption.
- •Body mass index (BMI)≥ 30 kg m-2
- •Chronic use of gabapentin or pregabalin
Arms & Interventions
Erector Spinae Block
Patients of this group will receive ultrasound guided erector spinae block with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected beneath the erector spinae muscle sheath at the level of the fourth transvers process (T4).
Intervention: Erector spinae plane block (Procedure)
Drain block
Patients of this group will receive local wound infiltration (drain block) with injection of (20 ml) of plain bupivacaine 0.25% (max dose 2mg/kg) injected in each surgical drain (pectoral and axillary drains) thereafter, the drains would then clamped for 20 minutes and declamped later on.
Intervention: local wound infiltration (Procedure)
Outcomes
Primary Outcomes
total morphine consumption
Time Frame: first postoperative day after modified radical mastectomy surgery
total morphine amount which will be consumed in the first postoperative day
Secondary Outcomes
No secondary outcomes reported
Investigators
tarek abdel hay mostafa
principle investigator
Tanta University