NCT06177652

Brief Summary

Thoracotomy is among the most painful surgical procedures and can cause severe pain. Postoperative pain causes many complications. Therefore, pain management is important in patients undergoing thoracotomy. For this purpose, systemic analgesics are used along with ultrasound-guided nerve blocks in thoracotomy pain. The effectiveness of thoracic paravertebral block and serratus plane block in the treatment of post-thoracotomy pain will be evaluated by comparing their effectiveness and complications on postoperative pain. Since the epidural spread of the thoracic paravertebral block is more effective, the effectiveness of postoperative pain relief will be more effective

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

2 active sites

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

June 1, 2022

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 20, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2024

Completed
Last Updated

March 10, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

December 11, 2023

Last Update Submit

March 5, 2025

Conditions

Keywords

Regional AnesthesiaParavertebral BlockSerratus Plane BlockThoracotomy

Outcome Measures

Primary Outcomes (1)

  • Morphin consumption

    Patient in both groups will provide with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia

    during postoperative 24 hour

Secondary Outcomes (1)

  • Visual Analogue Scale (VAS)

    during postoperative 24 hour

Study Arms (2)

Paravertebral Block

ACTIVE COMPARATOR

Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group.

Other: Paravertebral Block

Serratus Plane Block

ACTIVE COMPARATOR

Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group.

Other: Serratus Plane Block

Interventions

Ultrasound (US) -guided paravertebral block (PVB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the PVB group.

Paravertebral Block

Ultrasound (US) -guided serratus plane block (SPB) with 20 ml 0.5 % bupivacaine will performe preoperatively to all patients in the SPB group.

Serratus Plane Block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged patients
  • American Society of Anesthesiologists Classification (ASA) I-II-III patients
  • patients who scheduled elective thoracic surgery

You may not qualify if:

  • American Society of Anesthesiologists Classification (ASA) IV-V patients
  • patients with coagulopathy
  • patient with infection at the injection site

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Nur Nazire Yucal

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Tülay Çardaközü

    Kocaeli University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single(Participant)
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 11, 2023

First Posted

December 20, 2023

Study Start

June 1, 2022

Primary Completion

July 4, 2024

Study Completion

July 4, 2024

Last Updated

March 10, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations