Erector Spinae Plane, Paravertebral Versus Intercostal Nerve Block for VATS Surgery

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 .

Study Overview

• Status: Completed
• Conditions: Thoracic
• Intervention / Treatment: Other: Regional analgesia of thoracic surgical patients

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elgharbia
    • Tanta, Elgharbia, Egypt
      • Mona Mohamed Mogahed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA I and II patients
• Thoracic surgery

Exclusion Criteria:

• Coagulation defect

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; ultrasound-guided erector spinae block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position	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 .
Active Comparator: Group II; ultrasound-guided paravertebral block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position	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 .
Active Comparator: Group III; ultrasound-guided intercostal nerve block on T4 and T6 levels after the anesthesia induction and turning the patient in the lateral position	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
end tidal sevoflurane	intraoperative end tidal sevoflurane	150 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Intraoperative blood pressure in mmHg	150 minutes

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2021
• Primary Completion (Actual): January 10, 2022
• Study Completion (Actual): January 10, 2022

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 13, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: VATS; paravertebral; intercostal nerve block; Erector spinae plane
• Other Study ID Numbers: 34779/7/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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