Comparison of Analgesic Efficacy in Video-Assisted Thoracoscopic Surgery Patients

NCT ID: NCT06352398

Last Updated: 2024-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-04-01

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.

Detailed Description

The aim of the study is to evaluate the effect of erector spina plan block (ESPB) and Serratus posterior superior intercostal plan block (SPSIPB) on postoperative analgesia management.

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. Then 30 ml of 0.25% bupivacaine (1mg/kg) will be injected by negative aspiration.

In 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. The craniocaudal spread of local anaesthetic will be visualised by USG. Afterwards, the patients will be taken to the operation room and routine monitoring including ECG, peripheral oxygen saturation, non-invasive blood pressure arterial pressure monitoring and bispectral index (BIS) monitoring will be performed.

Conditions

Video-Assisted Thoracoscopic Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

erector spina plan block (ESPB)

erector 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.

Group Type: ACTIVE_COMPARATOR

erector spina plan block

Intervention Type: PROCEDURE

erector spina plan block

0.25% bupivacaine

Intervention Type: DRUG

Before the operation, 0.25% bupivacaine 30 ml was administered to both groups.

Serratus posterior superior intercostal plan block (SPSIPB)

In 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.

Group Type: ACTIVE_COMPARATOR

Serratus posterior superior intercostal plan block (SPSIPB)

Intervention Type: PROCEDURE

Serratus posterior superior intercostal plan block (SPSIPB)

0.25% bupivacaine

Intervention Type: DRUG

Before the operation, 0.25% bupivacaine 30 ml was administered to both groups.

Interventions

erector spina plan block

erector spina plan block

Intervention Type: PROCEDURE

Serratus posterior superior intercostal plan block (SPSIPB)

Serratus posterior superior intercostal plan block (SPSIPB)

Intervention Type: PROCEDURE

0.25% bupivacaine

Before the operation, 0.25% bupivacaine 30 ml was administered to both groups.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 52 healthy volunteers with VATS
• ASA 1-2-3
• 18 to 80 years old

Exclusion Criteria

• patients with coagulopathy
• wound and infection in the block area
• allergy to local anaesthetic drugs
• mental retardation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Burcu Bozdogan Tuysuz

OTHER

Sponsor Role: lead

Responsible Party

Burcu Bozdogan Tuysuz

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

burcu bozdogan tuysuz

Role: STUDY_DIRECTOR

medenıyet unıversıty

Locations

Istanbul Medenıyet Unıversıty

Istanbul, Kadıkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 36883093 (View on PubMed)

Related Links

https://pubmed.ncbi.nlm.nih.gov/36883093/

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Other Identifiers

BBTuysuz

Identifier Type: -

Identifier Source: org_study_id