The Effectiveness of Pain Relieve of Ultrasound-guided Erector Spinae Plane Block Versus Serratus Anterior Plane Block With General Anesthesia in Modified Radical Mastectomy Patient (Randomized Double-Blinded Controlled Clinical Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fayoum University Hospital
- Enrollment
- 62
- Locations
- 1
- Primary Endpoint
- The duration of analgesia of the two blocks
Study Overview
Brief Summary
Breast cancer is by far the world's most common cancer among women and the most common cause of female death from cancer worldwide. It's worldwide incidence is 43.4 in 100.000 while in Egypt is 48.8 in 100.000.
One of the most common surgical procedures for it is modified radical mastectomy (MRM), It is account for 31% of all breast surgery cases.
Post-mastectomy pain is a big problem affecting the outcome of surgery. It was used to be managed by opioids which may lead to many side effects such as nausea, vomiting, ileus, over sedation and respiratory depression. Chronic pain syndrome (phantom breast pain, paraesthesias, and intercostobrachial neuralgia) may be developed due to inadequate pain control.
So many regional analgesic techniques have been developed for effective pain control.
The safest and easiest is local wound infiltration with local anesthesia but the duration of action is limited. Intercostal nerve block and interpleural block are effective, but there is a fear of pneumothorax and transient Horner's syndrome.
Thoracic epidural analgesia is not preferred however it's efficacy because of possible neurological and hemodynamic side effects.
The gold standard now is thoracic paravertebral block (PVB) which provide effective analgesia with minimal hemodynamic derangement but it carries a risk of pneumothorax in addition to slightly complex technique.
Ultrasound-guided interfascial plane blocks such as pectoral nerve (PECS) block type 1 and 2 , serratus anterior plane block (SAPB) and erector spinae plane block (ESP) which is a recent block newly described for various surgeries for postoperative analgesia have also been reported as alternatives, with the advantages of simplicity, ease of performance and fewer complications.
there is no sufficient Randomized controlled trails that assess the effectiveness and safety of erector spinae plane block ESPB in controlling post mastectomy pain This study compares the analgesic efficacy of ultrasound-guided erector spinae plane block (ESPB) and serratus anterior plane block (SAPB) in patients undergoing MRM with axillary dissection.
Detailed Description
Preoperative preparation:
History taking, physical examination, and investigations will be done according to the local protocol designed to evaluate the patients. This includes complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile and electrocardiogram (ECG).
Before surgery, the participants will receive education about the VAS pain score (0-100 mm) (where0=no pain and 100 = worst comprehensible pain) and the details of the nerve block procedures. After 6 hours of fasting, the patients will be taken to the operation theatre.
Anesthetic management:
The patient will receive Midazolam 0.03 mg/kg intravenous (IV), Metoclopramide 10 mg IV, Ranitidine 50 mg IV and Cefotaxime 1 gm as a premedication.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •female aged >18 years with breast cancer eligible for modified radical mastectomy.
- •American Society of Anesthesiologists Physical Status I to IV.
Exclusion Criteria
- •Patient refusal.
- •body mass index (BMI) >
- •local infection at the site of the block.
- •local anesthetic allergy.
- •significant neurological or respiratory disease.
Arms & Interventions
SAPB group
Serratus Anterior Plane Block administered group
Intervention: Serratus Anterior Plane Block (Procedure)
ESPB group
Erector Spinae Plane Block administered group
Intervention: Erector Spinae Plane Block (Procedure)
Outcomes
Primary Outcomes
The duration of analgesia of the two blocks
Time Frame: At 48 hours postoperative
the pain will be assisted based on the time needed for the first dose rescue analgesia.
Secondary Outcomes
- Urine retension(At 72 hours postoperative)
- The cumulative opioids (morphine) consumption(At 48 hours postoperative)
- Nausea(At 72 hours postoperative)
- Pruritus(At 72 hours postoperative)
- Over-sedation(At 72 hours postoperative)
- The intervals between opioid (morphine) doses(At 48 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 48 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 48 hours postoperative)
- Incidences of complications related to both techniques(up to 72 hours postoperative)
- Vomiting(At 72 hours postoperative)
- The duration of surgery(Once at completion of surgery)
- Patients' satisfaction with postoperative analgesia(after 72 hours postoperative)
- Age(Once the patient is recruited)
- weight(Once the patient is recruited)
- Intraoperative fentanyl needed(Once at completion of surgery)
- Height(Once the patient is recruited)
- BMI(Once the patient is recruited)
- The cumulative opioids (morphine) consumption(At 24 hours postoperative)
- The intervals between opioid (morphine) doses(At 24 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At one hour postoperative)
- Nausea(At 48 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 6 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 12 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 18 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 24 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 30 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 36 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at rest(At 42 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At one hour postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 6 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 12 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 18 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 24 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 30 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 36 hours postoperative)
- The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction(At 42 hours postoperative)
- Nausea(At 2 hours postoperative)
- Nausea(At 6 hours postoperative)
- Nausea(At 12 hours postoperative)
- Nausea(At 24 hours postoperative)
- Vomiting(At 2 hours postoperative)
- Vomiting(At 6 hours postoperative)
- Vomiting(At 12 hours postoperative)
- Vomiting(At 24 hours postoperative)
- Vomiting(At 48 hours postoperative)
- Pruritus(At 2 hours postoperative)
- Pruritus(At 6 hours postoperative)
- Pruritus(At 12 hours postoperative)
- Pruritus(At 24 hours postoperative)
- Pruritus(At 48 hours postoperative)
- Over-sedation(At 2 hours postoperative)
- Over-sedation(At 6 hours postoperative)
- Over-sedation(At 12 hours postoperative)
- Over-sedation(At 24 hours postoperative)
- Over-sedation(At 48 hours postoperative)
- Urine retension(At 2 hours postoperative)
- Urine retension(At 6 hours postoperative)
- Urine retension(At 12 hours postoperative)
- Urine retension(At 24 hours postoperative)
- Urine retension(At 48 hours postoperative)
Investigators
Hany M Yassin, MD
Associated professor
Fayoum University Hospital