Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block

Trial Title: Mid-transverse Process Combined With Erector Spinae Block Versus Paravertebral Plane Block

NCT ID: NCT06618599

Condition: Lung Cancer

Conditions: Official terms:
Lung Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Group 1: received ipsilateral Ultrasound guided midtransverse block and ipsilateral Ultrasound guided ESPB block Group 2: paravertebral block(PVB): Patients received ipsilateral Ultrasound guided paravertebral plane block .

Primary purpose: Treatment

Masking: Double (Participant, Care Provider)

Masking description: double blind

Intervention:

Intervention type: Procedure
Intervention name: Mid-transverse process to pleura block combined with erector spinae block
Description: The probe will be placed vertically 3 cm lateral to the T5 spinous process and the transverse process will be identified. The needle will be introduced in an in-plane fashion until the tip lay deep in the erector spinae muscle. One milliliter of normal saline will be injected to confirm the correct needle tip position by visualizing the spread under the erector spinae muscle. 20 mL of 0.25% bupivacaine will be injected .The needle will be directed aiming for the midpoint between the transverse process and pleura from cephalad to caudad. One milliliter of normal saline will be given to confirm the position of the needle tip, then a total of 20 ml of 0.25% ropivacaine will be injected
Arm group label: Group 1:midtransverse to pleura block combined with erector spinae block

Intervention type: Procedure
Intervention name: paravertebral block
Description: the transducer will be positioned laterally 3 cm to the midline at T5 spinous process, defining the spinous process, pleura, transverse process, the paravertebral (PV) space, and superior costotransverse ligament. The trapezius, rhomboid major, and erector spinae muscles will be recognized as superficial to the hyperechoic transverse process shadow. However, when the rhomboid major muscle disappeared, this indicated that we will be at the 7th thoracic vertebra's level. Local infiltration using 2-3 mL of 2.0% lignocaine will be done. A spinal 22-gauge needle will be injected at the cephalic side of the transducer using an in-plane technique, and the needle directed towards the costotransverse ligament (CTL). The passage of the needle through the CTL will be associated with a pop, informing that the superior costotransverse ligament will be passed. Following a 3 mL testing dose of normal saline containing epinephrine (1:200,000), 30 mL bupivacaine 0.25% injected.
Arm group label: Group 2: paravertebral block

Summary: This study aims to compare efficacy of Mid-transverse process to pleura block combined with erector spinae block versus paravertebral plane block in cancer patients undergoing thoracotomy surgeries.

Detailed description: Thoracic paravertebral block (TPVB) application has also been used in recent years due to the lower incidence of side effects. The erector spinae plane block (ESPB)has been used as a part of multimodal analgesia in recent years. In ESPB is aimed to treat the postoperative pain of the thoracoabdominal region by injecting a local anesthetic into the interfacial area under the erector spinae muscle . ESPB creates an effect that covers the posterior and lateral thorax by affecting the dorsal rami and branches of the spinal nerves . Midtransverse process to pleura (MTP) block is less invasive as the position of the needle in this block is midway between the transverse process' posterior border and the pleura. Due to fenestrations present in the superior costotransverse ligament (SCTL), the drug reaches the paravertebral space

Criteria for eligibility:
Criteria:
Inclusion Criteria: - lung cancer patients for thoracotomy surgeries. - Physical status American Society of Anesthesiologists (ASA )II, III. - Age ≥ 18 and ≤ 65 Years. - Body mass index (BMI): > 20 kg/m2 and < 35 kg/m2 Exclusion Criteria: - Patient refusal - physical status ASA IV, - Age <18 years or >65 years - BMI < 20 kg/m2 and >35 kg/m2 - Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids). - History of psychological disorders and/or chronic pain. - Contraindication to regional anesthesia e.g., local sepsis, pre- existing peripheral neuropathies, and coagulopathy. - Severe respiratory, cardiac, hepatic or renal disease.

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: No

Locations:

Facility:
Name: Cairo University

Address:
City: Cairo
Zip: 11835
Country: Egypt

Status: Recruiting

Contact:
Last name: sayed M abed, MD degree

Phone: +201226806532
Email: sydabed2020@outlook.com

Start date: October 1, 2024

Completion date: November 1, 2025

Lead sponsor:
Agency: Cairo University
Agency class: Other

Source: Cairo University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06618599
https://jag.journalagent.com/scie/pdfs/SCIE-68926-RESEARCH_ARTICLE-BUKAGIKIRAN.pdf