NCT06352398

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 21, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2024

Completed
Last Updated

April 8, 2024

Status Verified

April 1, 2024

Enrollment Period

1 month

First QC Date

December 21, 2023

Last Update Submit

April 5, 2024

Conditions

Keywords

Erector spina plan block, postoperative analgesia

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 COMPARATOR

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.

Procedure: erector spina plan blockDrug: 0.25% bupivacaine

Serratus posterior superior intercostal plan block (SPSIPB)

ACTIVE COMPARATOR

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.

Procedure: Serratus posterior superior intercostal plan block (SPSIPB)Drug: 0.25% bupivacaine

Interventions

erector spina plan block

erector spina plan block (ESPB)

Serratus posterior superior intercostal plan block (SPSIPB)

Serratus posterior superior intercostal plan block (SPSIPB)

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

Serratus posterior superior intercostal plan block (SPSIPB)erector spina plan block (ESPB)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

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

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • burcu bozdogan tuysuz

    medenıyet unıversıty

    STUDY DIRECTOR

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

Locations