Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries

December 6, 2024 updated by: Ain Shams University

Ultrasound Guided Serratus Anterior Plane Block Versus Costotransverse Block on Postoperative Analgesia and Safety Following Modified Radical Mastectomy Surgeries

Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients will be divided randomly by the computer into three groups, group (A): will receive serratus anterior plane block, group (B): will receive costotransverse block and group(C): patient controlled analgesia group (PCA).

Group (A) (SAPB):

SAPB will be performed using an ultrasound machine with a high-frequency linear probe . All patients will be in lateral position to perform the block. At the level of the fourth rib with 45-degree angle, targeting the plane between the latissimus dorsi and serratus muscles, SAPB block will be performed unilaterally on the ipsilateral side of surgery.

Group (B) (CTB):

CTB will be performed using an ultrasound machine with a high-frequency linear probe. All patients will be in lateral position to perform the block. CTB block will be performed unilaterally on the ipsilateral side of surgery at the level of fourth rib.

Group (C) (patient controlled analgesia):

After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.

Study Type

Interventional

Enrollment (Estimated)

90

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 Locations

  • Egypt
    • Abbasia
      • Cairo, Abbasia, Egypt, 154411

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

Yes

Description

Inclusion Criteria:

  1. American Society of Anaesthesiologists (ASA) Physical Status Class I, II.
  2. Scheduled for modified radical mastectomy (MRM).
  3. Body weight ranging from 60 to 100 kilograms.

Exclusion Criteria:

  1. Declining to give a written informed consent.
  2. History of allergy to the medications used in the study.
  3. Contraindications to regional anesthesia (including patient: refusal, coagulopathy, and local infection).
  4. Psychiatric disorders.
  5. Significant cognitive dysfunction.
  6. American Society of Anesthesiologists (ASA) Physical Status Class III and IV.
  7. Daily use of opioids.
  8. Obesity (BMI > 35 kg/m2).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: serratus anterior plane block
while the patients in lateral position, serratus anterior plane block will be done using high frequency linear ultrasound probe at the level of fourth rib.30 ml of 0.25% bupivacaine will be injected.
Procedure: serratus anterior plane block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the plane between the latissimus dorsi and serratus muscles
Experimental: costotransverse plane block
while the patients in lateral position, costotransverse block will be done using 22-gauge echogenic needle. the needle is advanced in-plane lateral to the spinous process of the 4th thoracic vertebra from caudally cephalad.30 ml of 0.25% bupivacaine will be injected
Procedure: costotransverse block
using ultrasound, 30 ml of bupivacaine 0.25% will be injected in the costotransverse plane of fourth rib
Experimental: patient controlled analgesia
After successful extubation, patients will be transferred to PACU. Patients will receive a bolus dose of 5 mg nalbuphine then PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr with self-administration bolus of 0.5ml with 15 min lock-out time.
Procedure: patient controlled analgesia
PCA pump in the form of 20 mg nalbuphine HCL in 100 ml 0.9% normal saline with basal rate of infusion 5ml/hr. with self-administration bolus of 0.5ml with 15 min lock-out time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain
Time Frame: 24 hour post-operative
Visual Analogue Scale score will be assessed at both rest and arm elevation
24 hour post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24.
Time Frame: 24 hour post-operative
dose of nalbuphine consumed by patients
24 hour post-operative
Incidence of chronic pain after 6 months of surgery
Time Frame: 6 months after surgery
How many people develop chronic pain after surgery
6 months after surgery

Collaborators and Investigators

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

Sponsor

Ain Shams 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 (Actual)

December 28, 2023

Primary Completion (Estimated)

February 28, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

February 7, 2024

First Submitted That Met QC Criteria

February 7, 2024

First Posted (Actual)

February 15, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • analgesia for MRM surgeries

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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