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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05091398
Other study ID # 34779/7/21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 5, 2021
Est. completion date January 10, 2022

Study information

Verified date January 2022
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The optimal analgesia method in video-assisted thoracoscopic surgery (VATS) remains controversial. 105 patients scheduled to undergo video-assisted thoracic surgery under general anesthesia will be included. Patients will be randomly allocated to receive ultrasound-guided ESP blocks on T4 and T6 levels (Group ESPB, n = 35),PVB (Group PVB, n = 35) after the anesthesia induction and turning the patient in the lateral position or (Group ICNB, n=35) with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .


Description:

Standard general anesthesia was applied Patients will be randomly allocated to receive single shot of ESP blocks (Group ESPB), Paravertebral blocks (Group PVB) or (Group ICNB )at T4 and T6 levels according to a random number list that will be generated by a computer and will be stored in sealed envelopes. An independent experienced anesthesiologist will perform the first two blocks or surgeon will perform the third one through the thoracoscope according to the random number. The study coordinator, attending anesthesiologist, data collection resident and the patients will be all blinded to the treatment group assignment. All blocks will be applied on patient's back in a lateral position. Postoperative analgesia regimen consisted of a continuous infusion of iv iboprofen and morphine as a second rescue drug. Demographic data, past medical history, surgical and anesthetic data will be documented. Postoperative pain scores, consumption of analgesia and quality of recovery will be recorded to evaluate the analgesic effect.


Recruitment information / eligibility

Status Completed
Enrollment 105
Est. completion date January 10, 2022
Est. primary completion date January 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - ASA I and II patients - Thoracic surgery Exclusion Criteria: - Coagulation defect

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Regional analgesia of thoracic surgical patients
ultrasound-guided erector spinae block on T4 and T6 levels ,paravertebral block or intercostal nerve block after the anesthesia induction and turning the patient in the lateral position with 30 mL 0.5% bupivacaine +50 µ adrenaline will be injected by the surgeon through the thoracoscope .

Locations

Country Name City State
Egypt Mona Mohamed Mogahed Tanta Elgharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary end tidal sevoflurane intraoperative end tidal sevoflurane 150 minutes
Secondary Blood pressure Intraoperative blood pressure in mmHg 150 minutes
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