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

NCT06618599 | Recruiting

• 1 other identifier: analgesia in thoracotomy
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• visual analogue score changes during rest and cough for the three groups.

  the score of visual analogue score, with minimum score of 0 and maximum of 10, with higher scores meaning more severe pain

  for 24 hours postoperative

Study Arms (2)

Group 1:midtransverse to pleura block combined with erector spinae block

EXPERIMENTAL

Patients received ipsilateral Ultrasound guided midtransverse block with injection of 20 ml bupivacaine 0.25% and ipsilateral Ultrasound guided ESPB block with injection of 20 ml bupivacaine 0.25%

Procedure: Mid-transverse process to pleura block combined with erector spinae block

Group 2: paravertebral block

EXPERIMENTAL

Patients received ipsilateral Ultrasound guided paravertebral plane block with injection of 30 ml bupivacaine 0.25%.

Procedure: paravertebral block

Interventions

Mid-transverse process to pleura block combined with erector spinae block PROCEDURE

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

Group 1:midtransverse to pleura block combined with erector spinae block

paravertebral block PROCEDURE

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.

Group 2: paravertebral block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, 11835, Egypt

RECRUITING

Related Publications (3)

• Zengin M, Alagoz A. Comparison of Thoracic Epidural Analgesia and Thoracic Paravertebral Block Applications in the Treatment of Acute Pain After Thoracotomy in Geriatric Patients. Cureus. 2021 Oct 22;13(10):e18982. doi: 10.7759/cureus.18982. eCollection 2021 Oct.

  PMID: 34820237 BACKGROUND

• Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

  PMID: 26509324 BACKGROUND

• Liu L, Ni XX, Zhang LW, Zhao K, Xie H, Zhu J. Effects of ultrasound-guided erector spinae plane block on postoperative analgesia and plasma cytokine levels after uniportal VATS: a prospective randomized controlled trial. J Anesth. 2021 Feb;35(1):3-9. doi: 10.1007/s00540-020-02848-x. Epub 2020 Sep 4.

  PMID: 32886200 BACKGROUND

Related Links

• https://jag.journalagent.com/scie/pdfs/SCIE-68926-RESEARCH\_ARTICLE-BUKAGIKIRAN.pdf

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• sayed M Abed

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

sayed M abed, MD degree

CONTACT

+201226806532; sydabed2020@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Model Details: 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 .

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: basal
• Access Criteria: web

Locations

EG (1)