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

NCT05044858 | Unknown

• 1 other identifier: 34646/4/21
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-emptive; Postoperative Pain; Thoracotomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The amount of Postoperative morphine consumption

  24 hours Postoperative

• Time to the first rescue analgesia request

  24 hours Postoperative

• SpO2/FiO2 ratio

  24 hours Postoperative

Study Arms (2)

Midpoint transverse process block group

EXPERIMENTAL

Patients will receive midpoint transverse process block after induction of general anesthesia and before surgical incision

Procedure: Midpoint transverse process block group

Sham group

SHAM COMPARATOR

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

Interventions

Midpoint transverse process block group PROCEDURE

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

Midpoint transverse process block group

Sham group PROCEDURE

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.

Sham group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Faculty of Medicine Tanta University

Tanta, Elgarbia, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Heba A. Mohamed, M.B.B.CH

CONTACT

+20 111 505 4431; Heba154537_pg@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Anesthesiology and Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: September 9, 2021
• First Posted: September 16, 2021
• Study Start: September 24, 2021
• Primary Completion: September 20, 2022
• Study Completion: September 20, 2022
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For one year after completion of the study

Locations

EG (1)