NCT06089512

Brief Summary

In this study, hypothesis is that the MTPB (mid point transverse process block), which is easier and has fewer complications in patients aged 18-80 undergoing video-assisted thoracic surgery (VATS), provides analgesia as effective as PVB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

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

November 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 29, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

September 29, 2023

Last Update Submit

October 12, 2023

Conditions

Keywords

thoracicanalgesiapost operative painsurgery-complication

Outcome Measures

Primary Outcomes (2)

  • Intraoperative analgesic effects of peripheral blocks

    Investigators will compare the intraoperative analgesic effects by opioid consumption in intraoperative phase.

    First day

  • Postoperative analgesic effects of peripheral blocks

    Visual Analogue Scale (VAS) will be used for postoperative analgesic effects.

    First day

Secondary Outcomes (2)

  • opioid consumed through PCA (patient controlled analgesia)

    first day

  • Side effects

    First day

Study Arms (3)

Control group

PLACEBO COMPARATOR

group receiving general anesthesia only

Procedure: Control group

paravertebral block group

ACTIVE COMPARATOR

received single-shot paravertebral block after induction of anesthesia.

Procedure: paravertebral block group

mid transverse process block group

ACTIVE COMPARATOR

received a mid-transverse process -to- pleura block after induction of anesthesia.

Procedure: Mid point transverse process block group

Interventions

Paravertebral block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

paravertebral block group

Mid point transverse process block was applied to the patients after induction of general anesthesia; Intraoperative opioid requirement and postoperative pain scores and analgesic requirement were evaluated.

mid transverse process block group
Control groupPROCEDURE

Only general anesthesia was applied to the patients.

Control group

Eligibility Criteria

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

You may qualify if:

  • Patients between 18 and 80 years of age
  • American Society of Anesthesiologists I-II physical status of and
  • Body mass index of 19 to 28 kg/m2

You may not qualify if:

  • Patients who had coagulopathy
  • Previous thoracic surgery
  • Emotional instability
  • Significant encephalopathy
  • Preexisting motor or sensory deficit
  • Other contraindications to local anaesthesia, such as allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bursa Uludag University

Bursa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • seda cansabuncu

    BURSA ULUDAG UNIVERSITY HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 18, 2023

Study Start

November 1, 2022

Primary Completion

August 15, 2023

Study Completion

August 20, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

we plan share ,study Protocol, statistical Analysis Plan (SAP), informed Consent Form (ICF)

Locations