Compare the Perioperative Analgesic Effect of Ultrasound Guided Thoracic Paravertebral Block and Ultrasound Guided Serratus Anterior Block in Patients Undergoing Thoracotomy

NCT06831578 | Completed Phase 2

• 1 other identifier: 10/2024 ANESTH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of this study is to compare the perioperative analgesic effect of ultrasound guided thoracic paravertebral block and ultrasound guided serratus anterior block in patients undergoing thoracotomy.

Conditions

Thoracotomy; Thoracotomy Analgesia

Keywords

analgesia; thoracotomy

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  with the use of the visual analouge scale (VAS) in the preoperative visit. Where 0 score as no pain and 10 as the worst imaginable pain.

  postoperative up to 24 hours

Study Arms (2)

serratus anterior plane block

ACTIVE COMPARATOR

Procedure: seratuse anterior plane block

paravertebral plane block

ACTIVE COMPARATOR

Procedure: paravertebral plane block

Interventions

seratuse anterior plane block PROCEDURE

after patient consenting, induction of anathesia Under sterile conditions, and while the patients will be still on the lateral position with the diseased side up after induction of anesthesia, a linear ultrasound transducer (10-12 MHz) will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage. Then counting down ribs till the seventh rib will be identified in the mid-axillar\]y line. The following muscles will be identified overlying the sixth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22-G, 50-mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane deep to the serratus anterior muscle . Under continuous ultrasound guidance, 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter.

serratus anterior plane block

paravertebral plane block PROCEDURE

after concenting patient, induction of anathesia Paravertebral plan block will be performed while the patient is still in lateral position and a linear ultrasound transducer (10-12 MHz) will be used for ultrasound guidance. A sagittal or transverse image can be obtained at the appropriate vertebral level. After image optimization, the Tuohy needle is advanced in plane until the tip rests in the thoracic paravertebral space. Injection of small amounts of fluid (hydrodissection) will aid in needle tip location. Saline or local anesthetic is injected through the Tuohy needle. The endpoint for a successful block is anterior displacement of the pleura. 20 ml of 0.25% bupivacaine will be injected then a catheter will be threaded. A continuous infusion of 5 ml/hr of 0.125% bupivacaine will be then started through the catheter. The catheter is threaded through the Tuohy needle and its position is confirmed by injecting local anesthetic or small air bubbles. Pleural depression should agai

paravertebral plane block

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : Patients 20 to 60 years old
• ASA physical status of class II and III.

You may not qualify if:

• Patients with severe respiratory disease
• preexisting neurologic deficit
• allergy to any of the study drug
• kypho-scoliosis
• presence of local infection
• on current chronic analgesic therapy, having history of opioid dependence'
• patient refusal
• inablity to communicate with the investigators
• who will require postoperative mechanical ventilation .

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (2)

Menoufia university hospital

Shebeen Elkom, Menoufia, Egypt

Location

Menoufia faculty of medicine hospital

Shebin Elkom, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lectuer of anathesia,intensive care and pain

Model Details: Consenting patients will be assigned randomly (1:1) into two groups. Both groups will receive general anesthesia and after induction an ultrasound guided serratu anterior plan block will be performed for one group and an ultrasound guided paravertebral plan block will be performed for the other. In both groups a loading dose of the local anesthetic (LA) solution( 20 ml of 0.25% bupivacaine ) will be injected before the surgical procedure

Study Record Dates

• First Submitted: February 9, 2025
• First Posted: February 18, 2025
• Study Start: December 10, 2023
• Primary Completion: February 10, 2025
• Study Completion: February 10, 2025
• Last Updated: February 18, 2025

Record last verified: 2024-05

Locations

EG (2)