Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Thoracotomy Incisions

Postoperative Pain Clinical Trial

Official title:

Analgesic Efficacy of Pre-emptive Ultrasound-Guided Mid-Point Transverse Process to Pleura Block for Patients Undergoing Posterolateral Thoracotomy Incisions: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044858
• Other study ID #: 34646/4/21
• Status: Recruiting
• Phase: N/A
• Start date: September 24, 2021
• Est. completion date: September 20, 2022

Study information

• Verified date: September 2021
• Source: Tanta University
• Contact: Heba A. Mohamed, M.B.B.CH
• Phone: +20 111 505 4431
• Email: Heba154537_pg[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is designed to investigate the analgesic efficacy of pre-emptive ultrasound-guided midpoint transverse process to pleura (MTP) block for posterolateral thoracotomy in cardiothoracic surgeries.

Description:

Preemptive preoperative analgesia was first proposed, over the years it has been gradually regarded as an intervention given before incision, facilitating mobilization and functional rehabilitation after surgery, reducing postoperative opioid consumption, decreasing the incidence of adverse events and improving patient satisfaction. The Mid Transverse Process to Pleura block, described by Costach et al. involves deposition of drug midway between the transverse process and pleura. Costach et al. postulated that the local anesthetic deposited at this point may reach the paravertebral space through several possible mechanisms, such as spread medially through the gap between the superior costotransverse ligament (SCTL) and vertebral bodies, through fenestrations in SCTL, and laterally through the internal intercostal membrane

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: September 20, 2022
• Est. primary completion date: September 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients aged 21- and65 years old
• American Society of Anesthesiologists (ASA) II-III
• Scheduled for posterolateral thoracotomy operation under general anesthesia

Exclusion Criteria:

• Patients with bleeding disorders,
• Mental or cognitive dysfunction
• History of chronic analgesic or drug abuse
• Allergy to local anesthetics
• Local infection at site of block

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Thoracotomy

Intervention

Procedure:
• Midpoint transverse process block group
After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient
• Sham group
General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic . On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated.

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Tanta University	Tanta	Elgarbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of Postoperative Pain	Postoperative pain will be assessed by the Numerical Rating Scale (NRS;0 no pain while 10 is the maximum pain) at 0,4,8,12,18, 24 hours during rest and cough. If the (NRS) is 4 or more, morphine 3mg will be titrated until pain relief is achieved using a short interval between boluses	24 hours postoperative
Secondary	The amount of Postoperative morphine consumption	Total morphine consumption at 24 hours after surgery	24 hours Postoperative
Secondary	Time to the first rescue analgesia request	Time till administration of first rescue analgesia	24 hours Postoperative
Secondary	SpO2/FiO2 ratio	SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively	24 hours Postoperative