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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04218149
Other study ID # KS01
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 1, 2019
Est. completion date October 1, 2019

Study information

Verified date April 2019
Source Sisli Hamidiye Etfal Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Interfacial plan blocks are becoming more widely used for postoperative analgesia because of their easier applicability and less risk of complications. In this study, we aimed to compare the effects of serratus plane block (SPB) and erector spinae plane block (ESPB) on postoperative analgesia in patients undergoing unilateral breast surgery


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 1, 2019
Est. primary completion date September 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- ASA I-II

- Age: 18 - 65 years

- unilateral breast surgery

Exclusion Criteria:

- Does not approve the study

- Pregnant

- Emergency

- ASA III-IV

- History of local anesthetic allergy

- Infection in the block area

- Coagulation disorder

- Morbid obesity (body mass index> 40 kg / m²)

- Severe organ failure

- Previous neurological deficit

- Psychiatric disease

- History of chronic pain

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Bupivacaine Injection
Block with bupivacaine

Locations

Country Name City State
Turkey SBÜ Sisli Hamidiye Etfal Egitim ve Arastirma Hastanesi Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Sisli Hamidiye Etfal Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain score Visual analog scale (0-10), <4 is adequate analgesia Postoperative 24 hours
Primary Postoperative tramadol consumption Postoperative opiodi consumption with patient controlled analgesia Postoperative 24 hours
Primary Rescue analgesic If VAS score is 4 or more, paracetamol 1 gr is administered Postoperative 24 hours
Secondary Analgesia time Time from block performing to first analgesia requirement Procedure
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