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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04443556
Other study ID # RISS THORACOTOMY
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 31, 2020
Est. completion date February 15, 2021

Study information

Verified date April 2021
Source Konya Training and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thoracotomy is one of the most painful surgery. Acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. This study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (RISS) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.


Description:

Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue RISS block. First catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date February 15, 2021
Est. primary completion date January 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients over 18 years of age undergoing elective thoracic surgery - American Society of Anesthesiologists (ASA) physical status I-III grade Exclusion Criteria: - Patient refusal - History of psychiatric and cognitive disorders. - Patients allergic to the drugs used in the study - Emergent surgery

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tramadol
Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
Other:
IV PCA
An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.

Locations

Country Name City State
Turkey Konya Education and Training Hospital Konya

Sponsors (1)

Lead Sponsor Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative pain Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain). postoperative 48 hour
Secondary Analgesic consumption Total opioid consumption after the surgery Postoperative 48 hour
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