Clinical trial NCT03579524: Comparison of Erector Spinae Plane Block With Serratus Anterior Plane Block for Breast Surgery
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Breast Cancer
Keywords: Erector Spinae Plane Block
Serratus Anterior Plane Block
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2018-07-06
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Intravenous access will be obtained with an 18-gauge intravenous (IV) cannula in the contralateral upper limb of the surgical site and monitors (pulse oximeter, electrocardiography, non-invasive blood pressure (NIBP) and capnography) will be applied.

All patients will receive pre-oxygenation with 100% O2 for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg and atracurium 0.5 mg/kg. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with target of End Tidal Carbon Dioxide Tension (EtCO2) ≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC), 0.5μg/kg fentanyl will be given intraoperatively when either heart rate or Non-Invasive Blood Pressure (NIBP) report an increase by more than 20% of the basal records. Anesthesia will be discontinued and tracheal extubation will be done once patient fulfilled the extubation criteria.

A high-frequency ultrasound probe Active Array L12-4 (8-13MHz) of an ultrasound machine (Philips clear vue350, Philips Healthcare, Andover MA01810™, USA).and a 22-gauge, 50 mm echogenic needle (Stimuplex D®; B Braun, Germany) will be used for performing the blocks.

Patients in group (S) will receive serratus anterior plane block and those in group (E) will receive Erector spinae plane block. Both of these blocks will be performed after induction of general anesthesia by an experienced anesthesiologist (who is well trained in ultrasound-guided regional anesthesia). After proper skin sterilization with povidone-iodine solution.

For the ultrasound-guided serratus anterior plane block, the patient will be placed in supine position with the arm abducted. Ribs will be counted in the mid-axillary line from downward upwards until the 5th ribs the linear probe will be placed horizontally then three muscles will be identified: latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior) .the thoracodorsal artery (slightly posterior) will be used as extra guide in the identification of the plane superficial to the serratus muscle. The needle will be inserted in-plane with respect to the ultrasound probe from supero-anterior to postero-inferior. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread over serratus anterior muscles, then a total 20 ml of bupivacaine 0.25% will be injected.

For the ultrasound-guided erector spinae plane block

At first the patient will be placed in a lateral decubitus with the operation site up. The vertebrae will be counted from cephalad to caudal direction until we reach T5 spinous process as the first palpable spinous process is C7. Ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows:

trapezius, rhomboid major, and erector spinae. The needle will be introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle (the needle tip contacts the tip of the transverse process), 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread under erector spinae muscle a total of 20 mL of 0.25% bupivacaine will be injected next.

Post-operative care Patients will be transferred to post-anesthetic care unit (PACU) for 2 hrs after anesthesia emergence. The patients will be discharged from the PACU after fulfilling the discharge criteria based on the modified Aldrete score\> 9 The patient will receive analgesic according to the local institutional protocol as the following (paracetamol 1gm IV infusion/8 hours, ketorolac 30 mg Intramuscular/12 hours) as 2 components of multimodal anesthesia regimen for postoperative pain control.

A postoperative rescue analgesia with morphine sulfate IV per a titration protocol (3 mg IV as a bolus dose which can be repeated every 5 minutes with a maximum dose of 15mg per 4 hours or 45mg per 24 hours) will be employed if visual analog pain scale (VAS) \> 4. The morphine titration protocol will be suspended with Oxygen saturation \< 95%; Respiratory rate \< 10 / min; the development of sedation (Ramsay sedation scale \>2); development of acute adverse effects (allergy, marked itching, excessive vomiting, and hypotension with systolic blood pressure less than 20% of baseline values); or attaining adequate level of analgesia.

Eligibility criteria: 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) \> 40.
* local infection at the site of the block.
* local anesthetic allergy.
* significant neurological or respiratory disease.

Primary outcomes:
measure: The duration of analgesia of the two blocks
timeFrame: At 48 hours postoperative
Secondary outcomes:
measure: The cumulative opioids (morphine) consumption
timeFrame: At 24 hours postoperative
measure: The cumulative opioids (morphine) consumption
timeFrame: At 48 hours postoperative
measure: The intervals between opioid (morphine) doses
timeFrame: At 24 hours postoperative
measure: The intervals between opioid (morphine) doses
timeFrame: At 48 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At one hour postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 6 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 12 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 18 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 24 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 30 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 36 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 42 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at rest
timeFrame: At 48 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At one hour postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 6 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 12 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 18 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 24 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 30 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 36 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 42 hours postoperative
measure: The quality of analgesia based on visual analogue scale (VAS) pain score at arm abduction
timeFrame: At 48 hours postoperative
measure: Incidences of complications related to both techniques
timeFrame: up to 72 hours postoperative
measure: Nausea
timeFrame: At 2 hours postoperative
measure: Nausea
timeFrame: At 6 hours postoperative
measure: Nausea
timeFrame: At 12 hours postoperative
measure: Nausea
timeFrame: At 24 hours postoperative
measure: Nausea
timeFrame: At 48 hours postoperative
measure: Nausea
timeFrame: At 72 hours postoperative
measure: Vomiting
timeFrame: At 2 hours postoperative
measure: Vomiting
timeFrame: At 6 hours postoperative
measure: Vomiting
timeFrame: At 12 hours postoperative
measure: Vomiting
timeFrame: At 24 hours postoperative
measure: Vomiting
timeFrame: At 48 hours postoperative
measure: Vomiting
timeFrame: At 72 hours postoperative
measure: Pruritus
timeFrame: At 2 hours postoperative
measure: Pruritus
timeFrame: At 6 hours postoperative
measure: Pruritus
timeFrame: At 12 hours postoperative
measure: Pruritus
timeFrame: At 24 hours postoperative
measure: Pruritus
timeFrame: At 48 hours postoperative
measure: Pruritus
timeFrame: At 72 hours postoperative
measure: Over-sedation
timeFrame: At 2 hours postoperative
measure: Over-sedation
timeFrame: At 6 hours postoperative
measure: Over-sedation
timeFrame: At 12 hours postoperative
measure: Over-sedation
timeFrame: At 24 hours postoperative
measure: Over-sedation
timeFrame: At 48 hours postoperative
measure: Over-sedation
timeFrame: At 72 hours postoperative
measure: Urine retension
timeFrame: At 2 hours postoperative
measure: Urine retension
timeFrame: At 6 hours postoperative
measure: Urine retension
timeFrame: At 12 hours postoperative
measure: Urine retension
timeFrame: At 24 hours postoperative
measure: Urine retension
timeFrame: At 48 hours postoperative
measure: Urine retension
timeFrame: At 72 hours postoperative
measure: The duration of surgery
timeFrame: Once at completion of surgery
measure: Intraoperative fentanyl needed
timeFrame: Once at completion of surgery
measure: Patients' satisfaction with postoperative analgesia
timeFrame: after 72 hours postoperative
measure: Age
timeFrame: Once the patient is recruited
measure: weight
timeFrame: Once the patient is recruited
measure: Height
timeFrame: Once the patient is recruited
measure: BMI
timeFrame: Once the patient is recruited
Other outcomes:
Locations:
city: Madīnat al Fayyūm
country: Egypt
facility: Fayoum University hospital
state: Faiyum Governorate
Study officials:
affiliation: Fayoum University Hospitals
name: Hany M. Yassin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fayoum University Hospital
name: Mohamed A. Shawky, MD
role: STUDY_CHAIR
References:
citation: Bonvicini D, Giacomazzi A, Pizzirani E. Use of the ultrasound-guided erector spinae plane block in breast surgery. Minerva Anestesiol. 2017 Oct;83(10):1111-1112. doi: 10.23736/S0375-9393.17.12015-8. Epub 2017 May 11. No abstract available.
citation: Bonvicini D, Tagliapietra L, Giacomazzi A, Pizzirani E. Bilateral ultrasound-guided erector spinae plane blocks in breast cancer and reconstruction surgery. J Clin Anesth. 2018 Feb;44:3-4. doi: 10.1016/j.jclinane.2017.10.006. Epub 2017 Oct 21. No abstract available.
citation: Veiga M, Costa D, Brazao I. Erector spinae plane block for radical mastectomy: A new indication? Rev Esp Anestesiol Reanim (Engl Ed). 2018 Feb;65(2):112-115. doi: 10.1016/j.redar.2017.08.004. Epub 2017 Nov 2. English, Spanish.
citation: Kimachi PP, Martins EG, Peng P, Forero M. The Erector Spinae Plane Block Provides Complete Surgical Anesthesia in Breast Surgery: A Case Report. A A Pract. 2018 Oct 1;11(7):186-188. doi: 10.1213/XAA.0000000000000777.
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.
citation: Matsumoto M, Flores EM, Kimachi PP, Gouveia FV, Kuroki MA, Barros ACSD, Sampaio MMC, Andrade FEM, Valverde J, Abrantes EF, Simoes CM, Pagano RL, Martinez RCR. Benefits in radical mastectomy protocol: a randomized trial evaluating the use of regional anesthesia. Sci Rep. 2018 May 18;8(1):7815. doi: 10.1038/s41598-018-26273-z.
citation: Gupta K, Srikanth K, Girdhar KK, Chan V. Analgesic efficacy of ultrasound-guided paravertebral block versus serratus plane block for modified radical mastectomy: A randomised, controlled trial. Indian J Anaesth. 2017 May;61(5):381-386. doi: 10.4103/ija.IJA_62_17.