Study Results
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Basic Information
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RECRUITING
NA
75 participants
INTERVENTIONAL
2024-05-10
2024-08-01
Brief Summary
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Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as paravertebral block and thoracic epidural anathesia has possible complications and technical difficulties.
The new alternative regional techniques such as erector spinae plane block and serratus anterior plane block are clinical trials for providing a safe, easy and painless anesthetic procedure with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opiods consumption and subsequently avoid opiod-related adverse effects.
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Detailed Description
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With improved diagnostic techniques and treatment regimens, prognosis in breast cancer is improving, with the 5-year survival of patients diagnosed with primary breast cancer having increased to approximately 85%. Persistent post-surgical pain states in this group is reported in 30-50% of patients, up to half of whom may have pain well beyond 5 years. Over one-third of patients who underwent breast cancer surgery have inadequately controlled acute post-operative pain.
There are several ways to manage pain after mastectomy. Common systemic medications, particularly opioids, have different side effects, such as itching, nausea, vomiting and respiratory depression. Non-steroidal anti-inflammatory drugs are associated with impaired renal function and hemorrhagic disorders.
Regional anesthesia has been believed as one of the formats for effective perioperative pain control. Regional blocks using ultrasound-guide has become a perfect supplement to general anesthesia for extending analgesia after modified radical mastectomy. The advantage includes post-operative pain relief prolongation, a decrease in analgesic requirement post-operatively, a reduction in nausea and vomiting scores and probability for ambulatory discharge and hospital stay.
The complex innervation of breast tissues poses a great challenge for the anesthesiologists to provide adequate perioperative analgesia by ultrasound guided regional blocks. Thoracic epidural, interscalene brachial plexus block, paravertebral block, pectoral nerve I and pectoral nerve II blocks have been used in different studies with good results. There are also technically simple regional blocks as ultrasound-guided Serratus anterior Plane (US-guided SAP) block and erector spinae plane (US-guided ESP) block which can be used effectively for this purpose.
Forero et al. described ultrasound-guided Erector Spinae Plane (US-ESP) block as a novel analgesic technique in which local anesthetic injection is done beneath the erector spinae muscle. Previous studies reported effective postoperative pain reduction with ESP block after radical mastectomy surgery. Nevertheless, few studies have compared the efficacy of ESP block with another block technique.
The Serratus Anterior Plane block (SAP) provides anterolateral and partial posterior thoracic wall analgesia, affecting dermatomes from T2 to T9. SAP is affecting predominantly the lateral cutaneous branches of the thoracic intercostal nerves, along with intercostobrachial, thoracodorsal and long thoracic nerves. The block is performed further posteriorly and caudally than Pectoral Nerve Block-2, where the target nerves are located between the serratus anterior and the latissimus dorsi muscles.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Erector Spinae Plane Block
patient place in sitting position. Type of needle Using 22-gauge spinal needle 10 cm Linear ultrasound probe is placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process.
The erector spinae muscle is identified superficial to the tip of The T5 transverse process.
Needle insertion The needle is inserted in- plane superior to inferior approach. The tip of the needle is placed into the fascial plane on the deep aspect of erector spinae muscle.
The location of the needle tip is confirmed by visible normal saline fluid spread separating erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging .
Local anesthetic and volume Injection of 20 ml of bupivacaine 0.25 %.
Erector Spinae Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach
Serratus Anterior Plane Block:
The patient lies supine with placing the ipsi-lateral upper limb in abduction at 90° positio Using 22-gauge spinal needle 10 cm length. After skin sterilization, Ultrasound device with high frequency \[9-12\] and superficial linear probe that is first placed inferior to the middle of the clavicle and moved laterally and downward to locate the 1st rib where pectoralis major and pectoralis minor muscles are identified at this US window.
The US probe is moved toward axilla till serratus anterior muscle is identified above 2nd, 3rd and 4th ribs. The transducer is held at a slightly oblique angle at the level of the 4th and 5th rib, with the upper edge supero-anterior and the lower edge infero-anterior.
Needle insertion After infiltration of the skin at puncture site with 3 ml of lidocaine 1%, the needle is inserted inplane between the anterior serratus and the latissimus dorsi muscle on the mid-axillary line.
Injection of 20 mL of 0.25% bupivacaine.
Serratus Anterior Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.
control group
patients will receive only general anesthesia for Modified Radical Mastectomy.
controll group
patient will receive general anesthesia
Interventions
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Erector Spinae Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach
Serratus Anterior Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.
controll group
patient will receive general anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age: 21 - 60 years old.
* Gender: female patients.
* Body mass index: \< 35 kg/m2.
* Physical status: ASA grade I-II (American society of anesthiologists).
* Type of operation: unilateral modified radical mastectomy operation.
Exclusion Criteria
* Chronic use of analgesics or drug dependence.
* Patients not able to understand pain assessment test.
* Anatomical abnormalities.
* Neuropathic disease.
* Pregnancy or breast feeding.
* Other contraindication of regional anesthesia e.g. septic focus at site of injection.
* patient with coagulopathy or on anticoagulant therapy.
21 Years
60 Years
FEMALE
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Asmaa Mohammed Galal El-Deen
lecture of anesthesia and ICU
Principal Investigators
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Halah I Zanfaly, MD
Role: PRINCIPAL_INVESTIGATOR
Zagazig University
Locations
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Zagazig
Zagazig, MD, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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Altiparmak B, Korkmaz Toker M, Uysal AI, Turan M, Gumus Demirbilek S. Comparison of the effects of modified pectoral nerve block and erector spinae plane block on postoperative opioid consumption and pain scores of patients after radical mastectomy surgery: A prospective, randomized, controlled trial. J Clin Anesth. 2019 May;54:61-65. doi: 10.1016/j.jclinane.2018.10.040. Epub 2018 Nov 3.
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.
Eldemrdash AM, Abdelzaam EM: By Ultrasonic-Guided Erector Spinae Block, Thoracic Paravertebral Block versus Serratus Anterior Plane Block by Articaine with Adrenaline during Breast Surgery with General Anesthesia: A Comparative Study of Analgesic Effect Post-Operatively: Double Blind Randomized, Controlled Trial, Open Journal of Anesthesiology 2019; 9: 68-82.
FitzGerald S, Odor PM, Barron A, Pawa A. Breast surgery and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2019 Mar;33(1):95-110. doi: 10.1016/j.bpa.2019.03.003. Epub 2019 Apr 6.
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.
Gad M, Abdelwahab K, Abdallah A, Abdelkhalek M, Abdelaziz M. Ultrasound-Guided Erector Spinae Plane Block Compared to Modified Pectoral Plane Block for Modified Radical Mastectomy Operations. Anesth Essays Res. 2019 Apr-Jun;13(2):334-339. doi: 10.4103/aer.AER_77_19.
Khemka R, Chakraborty A. Ultrasound-guided modified serratus anterior plane block for perioperative analgesia in breast oncoplastic surgery: A case series. Indian J Anaesth. 2019 Mar;63(3):231-234. doi: 10.4103/ija.IJA_752_18.
Metwally AA, Elfeky EM, Abo Elenain KM, Yousef IM: Scoring systems in Anesthesia. Nature and Science 2016; 14: 47-48.
Rahimzadeh P, Imani F, Faiz SHR, Boroujeni BV. Impact of the Ultrasound-Guided Serratus Anterior Plane Block on Post-Mastectomy Pain: A Randomised Clinical Study. Turk J Anaesthesiol Reanim. 2018 Sep;46(5):388-392. doi: 10.5152/TJAR.2018.86719. Epub 2018 Sep 4.
Ross VH, Pan PH, Owen MD, Seid MH, Harris L, Clyne B, Voltaire M, Eisenach JC. Neostigmine decreases bupivacaine use by patient-controlled epidural analgesia during labor: a randomized controlled study. Anesth Analg. 2009 Aug;109(2):524-31. doi: 10.1213/ane.0b013e31819518e4. Epub 2009 Apr 17.
Singh S, Kumar G, Akhileshwar. Ultrasound-guided erector spinae plane block for postoperative analgesia in modified radical mastectomy: A randomised control study. Indian J Anaesth. 2019 Mar;63(3):200-204. doi: 10.4103/ija.IJA_758_18.
Swami SS, Keniya VM, Ladi SD, Rao R. Comparison of dexmedetomidine and clonidine (alpha2 agonist drugs) as an adjuvant to local anaesthesia in supraclavicular brachial plexus block: A randomised double-blind prospective study. Indian J Anaesth. 2012 May;56(3):243-9. doi: 10.4103/0019-5049.98767.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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ZagazigS
Identifier Type: -
Identifier Source: org_study_id
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