NCT04294394

Brief Summary

Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy. Although thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

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

February 1, 2020

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 1, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2021

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

February 3, 2021

Status Verified

January 1, 2021

Enrollment Period

11 months

First QC Date

March 1, 2020

Last Update Submit

January 31, 2021

Conditions

Keywords

rhomboid blockerectör spinae block

Outcome Measures

Primary Outcomes (1)

  • rhomboid block versus erector spinae block in thorachotomy

    In this study, we aimed to compare the effects of rhomboid block and erector spinae block in pain control after thoracotomy

    the study will comlete in three month

Study Arms (3)

rhomboid block

With a 6-13 Mhz linear USG probe, at the thoracal level of 6-7 vertebra in the sagittal position, in the cranio-caudal direction with a 22 G and 100 mm block needle in the medial of the scapula, after entering the facial plane between the rhomboid muscle and the intercostal muscle, 0.25% bupivacaine 20 ml of the local anesthetic solution will be given.

Other: rhomboid block

erector spinae group

After the patient is taken in the lateral position, the probe T5 is 3 cm lateral to the spinous process, 22 G and 100 mm block needle with 6-13 Mhz linear ultrasonography and the facial plane between the transverse proces and the erector spina muscle is entered, and 20 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be given.

Other: erector spinae block

control group

For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.

Other: control

Interventions

Rhombid block, on the other hand, is a method which make up analgesia by providing lokal anestethetic enjection between intercostal muscles and rhomboid muscles and blocks between t3- t9 levels

rhomboid block

The Erector spinae plan block is a recently developed regional block method .Adminestering of lokal anesthetic between the transver proces and erector spinae muscles provides the dorsal and ventral branch blokades of regional spinal nerve and make up the analgesia.İt have a wide range usage such as surgery of thoracal and abdominal area

erector spinae group
controlOTHER

For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.

control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

18 to 75 years old patients will including in this study. Patients Asa Scores shold be ASA1,2,3

You may qualify if:

  • Patients between 18-75 years old
  • ASA1,2,3 group patients
  • Patients undergoing thoracotomy under general anesthesia

You may not qualify if:

  • The patient's refusal to participate in the study
  • Allergy to local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Derince Eğitim Ve Araştırma Hastanesi

Kocaeli, Derince, 41000, Turkey (Türkiye)

Location

Tahsin Şimşek

Istanbul, 34000, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor

Study Record Dates

First Submitted

March 1, 2020

First Posted

March 4, 2020

Study Start

February 1, 2020

Primary Completion

January 5, 2021

Study Completion

January 15, 2021

Last Updated

February 3, 2021

Record last verified: 2021-01

Locations