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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05044858
Other study ID # 34646/4/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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