A Comparative Study Between Ultrasound Guided Thoracic Paravertebral Block VS Serrartus Anterior Muscle Block in VATS as Regard Their Effectiveness in Post-operative Analgesia

NCT05971368 | Unknown DMC

• 1 other identifier: paravertebral vs serratus
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

A comparative study between ultrasound guided thoracic paravertebral block VS ultrasound guided serrartus anterior muscle block in video-assisted thoracoscopic surgeries as regard their effectiveness in post-operative analgesia

Conditions

Post Operative Pain, Acute

Keywords

regional anesthesia

Outcome Measures

Primary Outcomes (2)

• total amount of opioid consumption in the two groups according to change in VAS score

  Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 3 will be managed by injection of nalbuphine 0.05mg / kg intravenously as a first rescue analgesia to reduce VAS score ≤ 3 and another titrating dose (2-3 mg nalbuphine) will be considered if the patient is still complaining in order to reach VAS score ≤ 3 (with maximum dose of 10 mg nalbuphine at a time)

  the first 24 hours postoperatively

• visual analog scale (VAS)

  Postoperative pain will be assessed at time of evaluation or at any time the patient is complaining of pain by using visual analog scale (VAS) and VAS more than 4 will be managed by injection of nalbuphine 5mg intravenously as a first rescue analgesia to reduce VAS score ≤ 3

  the first 24 hours postoperatively

Secondary Outcomes (5)

• The onset of 1st analgesic request

  The first 24 hours postoperatively

• mean arterial blood pressure of the patients

  first 24 hours postoperatively

• onset of ambulation

  first 24 hours postoperatively

• complication of nerve block

  first 24 hours postoperatively

• heart rate of the patients

  first 24 hours postoperatively

Study Arms (2)

Group A: Patients will receive ultrasound guided thoracic paravertebral block

ACTIVE COMPARATOR

Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

Procedure: thoracic paravertebal block

Group B: Patients will receive ultrasound guided serratus anterior muscle block

ACTIVE COMPARATOR

Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.

Procedure: serratus anterior muscle block

Interventions

thoracic paravertebal block PROCEDURE

o Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. A high-frequency linear ultrasound probe will be placed between transverse processes from the T4 level (the level of port introduction) in the paramedian plane while patients is in the lateral decubitus position. The transverse processes, superior costotransverse ligaments, and pleura will be well visualized. The block needle (22 gauge) will be advanced until it crosses the superior costotransverse ligament. The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) in the thoracic paravertebral space. Depression of the pleura will be observed as a result of the spread of local anesthetic.

Group A: Patients will receive ultrasound guided thoracic paravertebral block

serratus anterior muscle block PROCEDURE

Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. While the patient is in the supine position, a high-frequency linear ultrasound probe will be placed horizontally on the mid-axillary line at the level of 4th or 5th ribs on the side of the block. The serratus anterior, latissimus dorsi, and intercostal muscles will be identified. The block needle (22-gauge) will be advanced below the serratus anterior muscle (SAM) towards the fifth rib (using in-plane technique). The prepared 0.25% bupivacaine will be administered at 0.4 mL/kg (max. 40 mL) between the SAM and the rib. It will be observed that the solution of local anesthesia will spread between the SAM and the rib.

Group B: Patients will receive ultrasound guided serratus anterior muscle block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients American Society of Anesthesiologists physical status (ASA) I to II
• Both sexes.
• Aged ≥ 20 to ≤ 65years.
• Scheduled for VATS under general anesthesia.

You may not qualify if:

• Patient's refusal.
• Patients American Society of Anesthesiologists physical status (ASA) III to IV
• Patients with major spine deformities.
• Disruption of the local anatomy, secondary, for instance, to the presence of chest drains or surgical emphysema, resulting in difficulty in ultrasound interpretation and distortion of tissue planes.
• Patients with bleeding disorders and coagulopathy.
• Infection at the injection site.
• Known allergy to local anesthetics.
• Patients with pre-existing myopathy or neuropathy.
• Ipsilateral diaphragmatic paresis.
• Tumors in the paravertebral space at the level of injection.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of medicine Ain shams university

Cairo, Abbasia, 1181, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Central Study Contacts

aya gamal abdelhamid, MSC

CONTACT

(202) 01067206719; ayagamal.3614@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: * Group A: Patients will receive ultrasound guided thoraxic paravertebral block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia. * Group B: Patients will receive ultrasound guided serratus anterior muscle block with 0.25% bupivacaine 0.4 ml/kg (max. 40 ml and not exceeding toxic dose of bupivacaine 2.5mg/kg) after induction of anesthesia.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: August 2, 2023
• Study Start: June 4, 2022
• Primary Completion: January 4, 2024
• Study Completion: February 10, 2024
• Last Updated: February 8, 2024

Record last verified: 2023-06

Locations

EG (1)