Comparison Between Erector Spinae Plane Block And Retrolaminar Block In Patients Undergoing VATS.

August 25, 2023 updated by: Islam M Sayed, Cairo University

Comparison Of The Analgesic Effect Of Ultrasound-Guided Erector Spinae Plane Block And Ultrasound-Guided Retrolaminar Block In Patients Undergoing Video Assisted Thoracoscopic Surgery: A Prospective, Randomized Study.

Post-Video-assisted thoracoscopic surgery pain is a challenging clinical problem that may be associated with increased morbidity and mortality. The current study tests two techniques of regional anaesthesia to control post Video-assisted thoracoscopic surgery pain

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Video-assisted thoracoscopic surgery (VATS) is increasingly being used to manage primary lung cancer and helps reduce postoperative pain. However, it is a fact that pain following VATS can be severe and long-lasting. According to previous study, 18.8% of patients who undergo VATS present with persistent pain 2 months after surgery .The provision of pain relief is a significant consideration, and thoracic epidural analgesia is often regarded to be the gold standard. However, epidural analgesia is not always ideal, and other practical regional methods of analgesia after VATS have been proposed as Erector Spinae Plane Block (ESPB) or retrolaminar block (RLB) .

The retrolaminar block (RLB) is a modified paravertebral block that administers local anesthetic between the lamina of the thoracic vertebra and the erector spinal muscles, using landmark technique or under ultrasound guidance. Previous clinical study reported that RLB provides a good analgesic effect after VATS but was inferior to para-vertebral block(PVB).

Erector spinae plane block (ESPB) is a relatively new interfascial block procedure first described for thoracic analgesia. Previous clinical studies reported that ESPB provides a good analgesic effect after VATS (comparable with PVB) and decreases morphine consumption after Lateral thoracotomy surgery. Thus, anaesthesiologists now have a greater choice for regional anaesthesia for thoracic analgesia. Although ESPB and RLB have similar puncture sites, Only one clinical study comparing ESPB and RLB in breast surgery has been reported , The mentioned study was also limited only to female patients. both blocks were compared with PVB but There is no clinical study that compares ESPB and RLB directly in VATS. Although the mechanisms of action of both ESPB and RLB have not yet been completely clarified, one cadaveric study indicated that ESPB leads to a broader spread of the local analgesic into a more extensive range of intercostal spaces from a single point of injection than RLB . Another cadaveric study reported that the lateral pathway, which is involved in the blockade of the intercostal nerve or the lateral cutaneous branches of the intercostal nerves, is the primary mechanism of ESPB, in contrast to RLB.

Based on these anatomical studies, we hypothesize that ESPB can be superior to RLB for postoperative analgesia after VATS.

Study Type

Interventional

Enrollment (Estimated)

44

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
      • Cairo, Egypt
        • Recruiting
        • Facalty of Medicine - Cairo University
        • Contact:

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
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • American Society of Anesthesiologists physical status class (ASA) I, II and III
  • Patients undergoing VATS.

Exclusion Criteria:

  1. Patient refusal
  2. Coagulopathy, bleeding disorders,
  3. In-ability to postpone anti-coagulation medications.
  4. infection at the injection site
  5. pregnancy, breastfeeding,
  6. severe obesity (body mass index > 35 kg/m2 )
  7. allergy to any drug used in the study
  8. preoperative daily use of a non-steroidal anti-inflammatory drug (NSAID) or opioids,
  9. Previous surgery in the thoracic vertebral region
  10. Liver dysfunction.
  11. Injury or a lesion at the block site.

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
Active Comparator: Erector spinae plane block
will receive a US-guided ESPB
Procedure: Erector spinae plane block
Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 3 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact the tip of the T4 transverse process , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. Adequacy of the block will be confirmed by ultrasonographic visualization of fluid spread (seen as a lifting of the erector spina muscles in both block) and after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.
Active Comparator: Retrolaminar block
will receive a US-guided RLB
Procedure: Retrolaminar block
Under aseptic precautions, the ultrasound transducer will be placed on the patient's back in a longitudinal paramedian orientation approximately 1 cm from the midline. A short-bevel, 80 mm 22-gauge insulated nerve block needle will be inserted using an in-plane approach to contact T4 lamina of the vertebra , After negative aspiration of blood, a total of 20 mL of 0.25% bupivacaine will be injected through the needle. And after 15 min, documenting the sensory blockade will be done by using a piece of ice or cold object. If the desired sensory level fails to be achieved (T4 - T8), patients will be excluded from the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total amount of morphine consumption in milligram in the first 24-hour postoperative in the two groups
Time Frame: 24-hour
ESPB compared to RLB for postoperative analgesia after VATS
24-hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Time is required to perform the technique in minutes.
Time Frame: intraoperative
between the start of US scanning and the local anesthetic injection
intraoperative
Heart Rate
Time Frame: intraoperative and 24 hours postoperative
Heart rate (Bpm) at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
intraoperative and 24 hours postoperative
Systolic arterial blood pressure
Time Frame: intraoperative and 24 hours postoperative
Systolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
intraoperative and 24 hours postoperative
Diastolic arterial blood pressure
Time Frame: intraoperative and 24 hours postoperative
Diastolic arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
intraoperative and 24 hours postoperative
Mean arterial blood pressure
Time Frame: intraoperative and 24 hours postoperative
Mean arterial blood pressure in millimetre mercury at15 minutes after blocks are done before the induction (baseline), immediately after intubation, every 10 minutes intraoperative, immediately after extubation, and every 4 hour in the ICU for the first 24 hours.
intraoperative and 24 hours postoperative
• Intraoperative cardioactive drug use
Time Frame: Intraoperative
The number of patients requiring ephedrine and atropine
Intraoperative
• Intraoperative analgesics
Time Frame: Intraoperative
The number of patients requiring additional doses of fentanyl. Total intraoperative IV fentanyl dose (above the standard two microgram / kilogram )
Intraoperative
• Pain score according to VAS score
Time Frame: 24 hours
VAS value obtained from the patient immediately after recovery from anesthesia then every 4 hours during the first 24 hours postoperatively.
24 hours
• First request of analgesia postoperative
Time Frame: 24 hours Postoperative
The elapsed time from the block procedure until the administration of the first postoperative rescue analgesia in hours
24 hours Postoperative
• Incidence of side effects related to opioid use
Time Frame: 24 hours Postoperative
(postoperative nausea and vomiting (PONV), constipation, pruritus, urinary retention) in postoperative time.
24 hours Postoperative
• Incidence of complications or side-effects related to the block
Time Frame: 24 hours
(bradycardia, hypotension, hematoma formation or intravascular injection).
24 hours

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Islam M Sayed, MS, Cairo 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)

February 1, 2023

Primary Completion (Estimated)

October 30, 2023

Study Completion (Estimated)

December 30, 2023

Study Registration Dates

First Submitted

June 17, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 25, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MD-327-2022

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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