NCT04999319

Brief Summary

Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Thoracotomy operations are associated with high levels of pain. With the use of ultrasound, many regional anesthesia techniques were described to provide effective postoperative analgesia. The aim of this study was to compare the postoperative effect of paravertebral block (PVB) and erector spinal plane block (ESPB) in thoracotomies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable postoperative-pain

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 10, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2022

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

August 5, 2021

Last Update Submit

January 25, 2022

Conditions

Postoperative Pain

Keywords

Postoperative painThoracotomyParavertebral blockErector spina plane block

Outcome Measures

Primary Outcomes (2)

  • Morphine consumption

    Morphine consumption (mg) of patients with patient controlled analgesia device

    Postoperative 24th hour

  • NRS score

    Numerating rating scale of the patients (between 0 and 10, 0 represents no pain and 10 represents the worst pain ever possible.

    Postoperative 24th hour

Study Arms (2)

PVB Group

ACTIVE COMPARATOR

Paravertebral block administered group

Procedure: PVB

ESPB group

ACTIVE COMPARATOR

Erector spinae plane block administered group

Procedure: ESPB

Interventions

PVBPROCEDURE

Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.

PVB Group
ESPBPROCEDURE

Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.

ESPB group

Eligibility Criteria

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

You may qualify if:

  • ASA I-III patients undergo elective thoracotomy surgeries.

You may not qualify if:

  • Obesity (BMI \> 35 kg/m2)
  • Infection of the skin at the site of the needle puncture area
  • Patients with known allergies to any of the study drugs
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kocaeli Unversity

Kocaeli, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

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

Study Record Dates

First Submitted

August 5, 2021

First Posted

August 10, 2021

Study Start

October 15, 2020

Primary Completion

January 5, 2022

Study Completion

January 25, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)