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

NCT ID: NCT06831578

Last Updated: 2025-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-10
• Study Completion Date: 2025-02-10

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.

Detailed Description

randomized, comparative study General anesthesia will be conducted

Conditions

Thoracotomy; Thoracotomy Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

serratus anterior plane block

Group Type: ACTIVE_COMPARATOR

seratuse anterior plane block

Intervention Type: 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.

paravertebral plane block

Group Type: ACTIVE_COMPARATOR

paravertebral plane block

Intervention Type: 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

Interventions

seratuse anterior plane block

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.

Intervention Type: PROCEDURE

paravertebral plane block

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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 .

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

Asmaa Mohamed Hamza Sedky

lectuer of anathesia,intensive care and pain

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia university hospital

Shebeen Elkom, Menoufia, Egypt

Menoufia faculty of medicine hospital

Shebin Elkom, , Egypt

Countries

Egypt

Other Identifiers

10/2024 ANESTH

Identifier Type: -

Identifier Source: org_study_id