Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

February 29, 2024 updated by: Alshaimaa Abdel Fattah Kamel, Zagazig University

Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy

Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)

Study Overview

Detailed Description

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

Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.

The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.

As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.

Study Type

Interventional

Enrollment (Estimated)

46

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

      • Zagazig, Egypt
        • Recruiting
        • Zagazig University, Faculty of medicine
        • Contact:
        • Principal Investigator:
          • Alshaimaa Kamel, M.D

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

21 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patient acceptance.
  • 21 - 64 years of age.
  • American Society of Anesthesiologist physical status class I,II.
  • Body Mass Index 25-35 kg/m2.
  • Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.

Exclusion Criteria:

  • Coagulation disorders or anticoagulant therapy.
  • Known allergy to study drugs (Bupivacaine, Fentanyl)
  • Infection at the injection site.
  • Patients having chronic pain or on pain treatment.
  • Advanced renal, respiratory, hepatic or cardiovascular disorders.
  • Uncooperative patients.
  • Duration of surgery > 3hours.
  • Pregnant or lactating females.
  • Metastasis.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: ultrasound guided Retrolaminar Block
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
Active Comparator: ultrasound guided erector spinae
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total fentanyl dose.
Time Frame: from induction to end of surgery
The anesthesiologist will administer intravenous fentanyl 0.5 μg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.
from induction to end of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity by Visual Analogue Scale
Time Frame: at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.

• Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively.

pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies.

at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Time of requirement of rescue dose of Fentanyl.
Time Frame: up to 24hour postoperative
Time of requirement of rescue dose of Fentanyl.
up to 24hour postoperative
Total amount of postoperative Fentanyl
Time Frame: up to 24hour postoperative
Total amount of Fentanyl consumed during the first 24 hours after surgery.
up to 24hour postoperative
Post-operative nausea and vomiting
Time Frame: up to 24hour postoperative
• Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting
up to 24hour postoperative
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
Time Frame: up to 24hour postoperative
Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
up to 24hour postoperative
Overall patient satisfaction
Time Frame: up to 24hour postoperative
• Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)
up to 24hour postoperative

Collaborators and Investigators

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

Investigators

  • Study Chair: Alshaimaa Kamel, M.D, Zagazig University

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)

February 1, 2021

Primary Completion (Estimated)

March 30, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (Actual)

August 28, 2020

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 6236 (CTEP)

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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