Anaesthesia
Conditions
Brief summary
The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.
Detailed description
During MRM , some of the nerves in the chest are affected so most women have some level of pain in the days after the procedure. Severe acute postoperative pain following breast surgery is an independent risk factor in the development of chronic post-mastectomy pain , not only increasing the risk of persistent agony and prolongs hospitalization, it also affects recovery and increases healthcare costs . Multimodal techniques for pain management have been recommended by the American Society of Anesthesiologists (ASA) for the management of acute postoperative pain . These techniques include oral analgesics as opioids, paracetamol and nonsteroidal anti inflammatory drugs (NSAIDs) , intravenous (IV) and regional analgesia. Inappropriate postoperative analgesia may increase morbidity and mortality . PECS-II block is an interfascial plane block in which local anesthetic is injected between serratus anterior and pectoralis muscles that blocks the pectoral nerve as well as the long thoracic, intercostobrachial and lateral cutaneous branches of the inter-costal III, IV, V, and VI nerves. PECS-II is a less invasive and easier to be performed alternative to thoracic paravertebral block (TPVB). This block, defined by Blanco et al., provides safe and adequate post-operative analgesia in the anterior chest wall after breast surgery. The most common complications are pneumothorax, vascular puncture, infection, local anesthetic systemic toxicity (LAST), allergy and failed block . ESPB is a paraspinal fascial plane block in which local anesthetic is injected between the tip of the transverse process of the spine and the anterior fascia of the erector spinae muscles blocking the dorsal and ventral rami of the spinal nerves, as well as the sympathetic chain, resulting in analgesia of chronic thoracic neuropathic pain, breast and upper abdominal surgeries. The block, defined by Forero et al., can cover several spinal nerve levels above and below the injection site as the local anesthetic spreads along the fascial plane, depending on the volume and concentration of the local anesthetic . The main advantages of this technique include the ease of performing it, the analgesic efficacy and the low risk of complications as Pneumothorax, hemi-diaphragmatic paralysis, motor weakness, and neurological findings related to local anesthesia toxicity .
Interventions
PROCEDUREModified Pectoral Plane block group
The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine.
PROCEDUREErector spinae plane block group.
The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients scheduled for MRM. 2. Age eligible ≥ 40 & ≤ 65 yrs. 3. Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.
Exclusion criteria
1. Age \< 40 & \> 65 years old. 2. Declining to give written informed consent. 3. History of allergy to the medications used in the study. 4. Contraindication to regional anesthesia \[including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection\]. 5. Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2). 6. Renal dysfunction \[GFR \< 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)\]. 7. Psychiatric disorder. 8. Pregnancy. 9. Patient with history of thoracic spine surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. | will be evaluated postoperatively on arrival to PACU (zero time) | Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | 24 hours post-operative | Post-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable). |
Countries
Egypt
Participant flow
Pre-assignment details
Twenty patients were enrolled and randomly divided into the two groups , 10 patients each .
Participants by arm
| Arm | Count |
|---|---|
| Pectoral Plane Block Group first group 10 patients
Modified Pectoral Plane block group: The patient will lay supine with the ipsilateral arm abducted and externally rotated and the elbow flexed at 90 degrees. The probe will be placed transversely between the clavicle medially and above and the shoulder joint laterally. After identifying the pectoralis major and minor muscles and the plane between them, the probe will be pushed 1-2 cm caudally and medially. In a caudal tilt, within a biconvex space, the artery will be recognised. After that, the block needle will be inserted in an in-plane approach to the artery's location and 10 mL of 0.25% bupivacaine will be administered Then probe will be moved laterally and caudally towards the anterior axillary fold until the serratus muscle appears beneath the pectoralis minor muscle attaching to the underlying ribs. The needle will target the plane between pectoralis minor and serratus muscles at the level of the third rib, followed by negative aspiration into the fascial plane then injection of 10 mL of 0.25 bupivacaine. | 10 |
| Erector Spinae Plane Block Group second group 10 patients
Erector spinae plane block group.: The block will be performed with the patient in a sitting position , The high-frequency linear probe will be placed in a longitudinal orientation 3 cm from the midline. Once the erector spinae muscle and the transverse processes identified, the block needle will be inserted in a caudad-to-cephalad direction until the tip lay in the interfacial plane deep to the erector spinae muscle, 20 mL of 0.25% bupivacaine will be administered for block performance. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Pectoral Plane Block Group | Erector Spinae Plane Block Group | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 1.9 | 52.1 years STANDARD_DEVIATION 7.3 | 53.4 years STANDARD_DEVIATION 5.33 |
| ASA Classification ASA I = A normal healthy patient | 4 participants | 3 participants | 7 participants |
| ASA Classification ASA II = A patient with mild systemic disease | 6 participants | 7 participants | 13 participants |
| BMI | 26.9 kilogram per meter squared STANDARD_DEVIATION 2.9 | 25.9 kilogram per meter squared STANDARD_DEVIATION 3 | 26.4 kilogram per meter squared STANDARD_DEVIATION 2.95 |
| breast-side bilateral | 2 Participants | 3 Participants | 5 Participants |
| breast-side unilateral | 8 Participants | 7 Participants | 15 Participants |
| height | 169.7 centimeters STANDARD_DEVIATION 3.9 | 167.8 centimeters STANDARD_DEVIATION 3.6 | 168.75 centimeters STANDARD_DEVIATION 3.75 |
| operation duration | 113.4 minutes STANDARD_DEVIATION 33.2 | 134.4 minutes STANDARD_DEVIATION 15.8 | 123.9 minutes STANDARD_DEVIATION 26 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 20 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| weight | 77.5 kilograms STANDARD_DEVIATION 7.8 | 72.8 kilograms STANDARD_DEVIATION 7 | 75.15 kilograms STANDARD_DEVIATION 7.41 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit.
Visual Analogue Scale is a scale for pain assessment ranging from 0 to 10 where 0 is minimum and means no pain while 10 is maximum and means maximum pain which means worse outcome
Time frame: will be evaluated postoperatively on arrival to PACU (zero time)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. | 0.4 score on a scale | Standard Deviation 0.5 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. | 0.9 score on a scale | Standard Deviation 0.3 |
Secondary
Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively.
Post-operative pain severity assessed by Visual analogue scale at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively where visual analogue scale ranges from zero to ten where (0 = no pain, 10 = maximum pain imaginable).
Time frame: 24 hours post-operative
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 2 hours postoperatively. | 1.3 score on a scale | Standard Deviation 0.5 |
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 12 hours postoperatively. | 2.5 score on a scale | Standard Deviation 0.7 |
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 18 hours postoperatively. | 1.9 score on a scale | Standard Deviation 0.6 |
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 8 hours postoperatively. | 2.8 score on a scale | Standard Deviation 0.6 |
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 24 hours postoperatively. | 1.6 score on a scale | Standard Deviation 0.5 |
| Modified Pectoral Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 4 hours postoperatvely. | 1.4 score on a scale | Standard Deviation 0.5 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 24 hours postoperatively. | 2 score on a scale | Standard Deviation 0.5 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 4 hours postoperatvely. | 3.1 score on a scale | Standard Deviation 0.3 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 2 hours postoperatively. | 1.9 score on a scale | Standard Deviation 0.3 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 8 hours postoperatively. | 3.8 score on a scale | Standard Deviation 0.9 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 12 hours postoperatively. | 3.4 score on a scale | Standard Deviation 1.1 |
| Erector Spinae Plane Block Group | Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. | Post-operative pain severity assessed by Visual analogue scale at 18 hours postoperatively. | 2.9 score on a scale | Standard Deviation 0.6 |