s Serratus Anterior Block for Perioperative Analgesia

May 8, 2024 updated by: Asmaa Mohammed Galal El-Deen, Zagazig University

Ultrasound-Guided Erector Spinae Block Versus Serratus Anterior Block for Perioperative Analgesia In Patients Undergoing Modified Radical Mastectomy Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Breast cancer is the most common malignancy of women all over the world. Unfortunately, two-thirds of women who undergo breast cancer surgery are reported to develop chronic pain in the postoperative period. Surgery type, radiation therapy, and clinically acute pain are the most important risk factors for the development of more intense chronic pain.

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 %.
Procedure: Erector Spinae Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Erector Spinae Plane Block approach
Other Names:
  • Group E
Active Comparator: 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.
Procedure: Serratus Anterior Plane Block
Patient will receive 20 ml of bupivacaine 0.25 % through Serratus Anterior Plane Block approach.
Other Names:
  • Group S
Active Comparator: control group
patients will receive only general anesthesia for Modified Radical Mastectomy.
Procedure: controll group
patient will receive general anesthesia
Other Names:
  • Group C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time of first analgesia requirement
Time Frame: during 24 hours postoperative
first time patient asks rescue analgesia and total morphine consumption post-operative.
during 24 hours postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
onset of Sensory block.
Time Frame: within 20 minutes after block
time needed for onset of sensory block.
within 20 minutes after block
assessment of sensory block
Time Frame: within 8 hours after giving block
quality and duration of block
within 8 hours after giving block

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
dynamic pain scores
Time Frame: at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.
Visual analog scale (VAS) of 0-10, where 0= No pain and 10= Maximum worst pain.
at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.
Static pain scores
Time Frame: at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.
Visual analog scale (VAS) of 0-10, where 0= No pain and 10= Maximum worst pain.
at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Investigators

  • Principal Investigator: Halah I Zanfaly, MD, Zagazig University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 10, 2024

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

May 8, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 8, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZagazigS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

planned after the completion of the study and publication

IPD Sharing Time Frame

planned after the completion of the study and publication

IPD Sharing Access Criteria

principal investigator

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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