s Serratus Anterior Block for Perioperative Analgesia

NCT06410378 | Recruiting

• 1 other identifier: ZagazigS
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimised, as in a number of women it may chronically persist for months in the form of postmastectomy pain syndrome. 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.

Conditions

Mastectomy; Postoperative Pain

Keywords

Erector Spinae Block; Serratus anterior Block; Perioperative Analgesia

Outcome Measures

Primary Outcomes (1)

• time of first analgesia requirement

  first time patient asks rescue analgesia and total morphine consumption post-operative.

  during 24 hours postoperative

Secondary Outcomes (2)

• onset of Sensory block.

  within 20 minutes after block

• assessment of sensory block

  within 8 hours after giving block

Other Outcomes (2)

• dynamic pain scores

  at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.

• Static pain scores

  at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.

Study Arms (3)

Erector Spinae Plane Block

ACTIVE COMPARATOR

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 %.

Procedure: Erector Spinae Plane Block

Serratus Anterior Plane Block:

ACTIVE COMPARATOR

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.

Procedure: Serratus Anterior Plane Block

control group

ACTIVE COMPARATOR

patients will receive only general anesthesia for Modified Radical Mastectomy.

Procedure: controll group

Interventions

Erector Spinae Plane Block PROCEDURE

Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach

Also known as: Group E

Erector Spinae Plane Block

Serratus Anterior Plane Block PROCEDURE

Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.

Also known as: Group S

Serratus Anterior Plane Block:

controll group PROCEDURE

patient will receive general anesthesia

Also known as: Group C

control group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent from the patient.
• 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.

You may not qualify if:

• Patient with known history of allergy to study drugs.
• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig

Zagazig, MD, 44519, Egypt

RECRUITING

Related Publications (12)

• 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.

  PMID: 30396100 BACKGROUND

• 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.

  PMID: 23923989 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 31272657 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 31198256 BACKGROUND

• 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.

  PMID: 30988539 BACKGROUND

• Metwally AA, Elfeky EM, Abo Elenain KM, Yousef IM: Scoring systems in Anesthesia. Nature and Science 2016; 14: 47-48.

  BACKGROUND

• 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.

  PMID: 30263863 BACKGROUND

• 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.

  PMID: 19377050 BACKGROUND

• 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.

  PMID: 30988534 BACKGROUND

• 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.

  PMID: 22923822 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Halah I Zanfaly, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa M Galal Eldin, MD

CONTACT

01200726092; asmaa.galal79@gmail.com

sara H Yousif, master

CONTACT

01015051856; Saraheikal10@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecture of anesthesia and ICU

Model Details: The patients will be divided randomly by a computer-generated randomization table into three equal groups

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: May 13, 2024
• Study Start: May 10, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: May 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: planned after the completion of the study and publication
• Access Criteria: principal investigator

Locations

EG (1)