Regional Anesthesia Morbidity
Conditions
Brief summary
Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.
Detailed description
Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA). Group (A) (SAPB): SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery. Group (B) (CTB): CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib. Group (C) (patient controlled analgesia): After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
Interventions
PROCEDUREserratus anterior plane block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles
PROCEDUREcostotransverse block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib
PROCEDUREpatient controlled analgesia
PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II. 2. Scheduled for modified radical mastectomy (MRM). 3. Body weight ranging from 60 to 100 kilograms.
Exclusion criteria
1. Declining to give a written informed consent. 2. History of allergy to the medications used in the study. 3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection). 4. Psychiatric disorders. 5. Significant cognitive dysfunction. 6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV. 7. Daily use of opioids. 8. Obesity (BMI \> 35 kg/m2).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain | 24 hour post-operative | Visual Analogue Scale score will be assessed at both rest and arm elevation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24. | 24 hour post-operative | dose of nalbuphine consumed by patients |
| Incidence of chronic pain after 6 months of surgery | 6 months after surgery | How many people develop chronic pain after surgery |
Countries
Egypt
Contacts
Primary ContactAbdalla Ma Abdalla, master
Outcome results
None listed