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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Thoracotomy; Pre-emptive
• Intervention / Treatment: Procedure: Midpoint transverse process block group; Procedure: Sham group

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heba A. Mohamed, M.B.B.CH; Phone Number: +20 111 505 4431; Email: Heba154537_pg@med.tanta.edu.eg

Study Locations

• Egypt
  • Elgarbia
    • Tanta, Elgarbia, Egypt, 31527
      • Recruiting
      • Faculty of Medicine Tanta University
      • Contact: Heba A. Mohamed, M.B.B.CH; Phone Number: +20 111 505 4431; Email: Heba154537_pg@med.tanta.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Midpoint transverse process block group; Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision	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 Comparator: 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)	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Anticipated): September 20, 2022
• Study Completion (Anticipated): September 20, 2022

Study Registration Dates

• First Submitted: September 9, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 34646/4/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon reasonable request from the principal investigator
• IPD Sharing Time Frame: For one year after completion of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No