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

Not Applicable

• Conditions: Postoperative Pain; Thoracotomy; Pre-emptive
• Interventions: Procedure: Sham group; Procedure: Midpoint transverse process block group

• Registration Number: NCT05044858
• Lead Sponsor: Tanta University

Brief 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.

Detailed 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

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-09
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-16
• Study Start: 2021-09-24
• Last Update Submitted: 2021-09-25
• Last Update Posted: 2021-10-01
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham group	Sham group	Patients will receive general anesthesia and the same intervention steps will be performed i.e., the block under investigation but instead of local anesthetic a placebo (2ml normal saline) will be injected (sham block)
Midpoint transverse process block group	Midpoint transverse process block group	Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision

Primary Outcome Measures

Name	Time	Method
The degree of Postoperative Pain	24 hours postoperative	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

Secondary Outcome Measures

Name	Time	Method
The amount of Postoperative morphine consumption	24 hours Postoperative	Total morphine consumption at 24 hours after surgery
Time to the first rescue analgesia request	24 hours Postoperative	Time till administration of first rescue analgesia
SpO2/FiO2 ratio	24 hours Postoperative	SpO2/FiO2 ratio at 6,8,12 and 24h postoperatively

Trial Locations

Locations (1)

Faculty of Medicine Tanta University; 🇪🇬 Tanta, Elgarbia, Egypt