Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients
1 other identifier
interventional
52
1 country
1
Brief Summary
The 52 patients included in the study were divided into two groups as ESPB (n=26) and SPSIPB (n=26). Before the operation, 0.25% bupivacaine 30 ml was administered to both groups. After admission to the operating room, all patients underwent standard anaesthesia procedures. Morphine 0.05 mg/kg i.v. and parol 1 g i.v. were administered 30 min before the end of the operation. Post operatively the patient was followed up with controlled analgesia. Demographic data, ASA scores, body mass indexes, peri-operative haemodynamic values, remifentanil consumption and duration of surgery were recorded. Post-operative first 24 hours NRS scores, morphine consumption, number of nausea and vomiting episodes were recorded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2023
CompletedFirst Submitted
Initial submission to the registry
December 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedFirst Posted
Study publicly available on registry
April 8, 2024
CompletedApril 8, 2024
April 1, 2024
1 month
December 21, 2023
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
morphine consumption first 24 hours
mg
up to 24 hours
Secondary Outcomes (1)
NRS pain score
up to 24 hours
Study Arms (2)
erector spina plan block (ESPB)
ACTIVE COMPARATORerector spina plan block (ESPB) : After providing asepsis and antisepsis conditions to the ESPB group in the sitting position, a high frequency linear USG probe will be placed approximately 2-3 cm lateral to the T5 spinous process in the longitudinal plane. After visualising the T5 transverse process with the in plane approach, the skin will be entered in the craniocaudal direction. Trapezius, rhomboid and erector spinae muscles will be passed and 5 ml of saline will be injected between the erector spinae muscle fascia and vertebral transverse process when the needle rests on the spinous process (approximately 3 cm deep) and the block site will be confirmed. Before the operation 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration.
Serratus posterior superior intercostal plan block (SPSIPB)
ACTIVE COMPARATORIn the SPSIPB group, the patient will be positioned in the lateral position, with the surgical side up and the upper extremity hanging over the patient's head for the USG-guided serratus posterior superior plan block. After asepsis and antisepsis conditions are provided, the spina scapula will be visualised above the scapula with our high frequency linear USG probe. The 3rd rib will be visualised with a high frequency probe medial to the scapula corresponding to the 3rd rib level. The ribs, pleura and the serratus muscle covering it will be determined and the needle tip will be advanced until it touches the 3rd rib.After the 3rd rib is visualised by USG, 5 ml isotonic is given and hydrodissection is performed, 30 ml 0.25% bupivacaine (1mg/kg) will be injected between the serratus posterior superior muscle and the 3rd rib.
Interventions
Serratus posterior superior intercostal plan block (SPSIPB)
Before the operation, 0.25% bupivacaine 30 ml was administered to both groups.
Eligibility Criteria
You may qualify if:
- healthy volunteers with VATS
- ASA 1-2-3
- to 80 years old
You may not qualify if:
- patients with coagulopathy
- wound and infection in the block area
- allergy to local anaesthetic drugs
- mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul Medenıyet Unıversıty
Istanbul, Kadıkoy, 34734, Turkey (Türkiye)
Related Publications (1)
Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
PMID: 36883093BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
burcu bozdogan tuysuz
medenıyet unıversıty
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 21, 2023
First Posted
April 8, 2024
Study Start
December 20, 2023
Primary Completion
February 1, 2024
Study Completion
April 1, 2024
Last Updated
April 8, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share