Effect of Continue RISS Block in Thoracotomy

April 18, 2021 updated by: Betul Kozanhan, Konya Meram State Hospital

Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey
        • Konya Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group Rhomboid Intercostal and Subserratus Plane Block
Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block
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 Names:
  • Local anesthetic
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.
OTHER: Control Group
Standart postoperative analgesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain
Time Frame: postoperative 48 hour
Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
postoperative 48 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analgesic consumption
Time Frame: Postoperative 48 hour
Total opioid consumption after the surgery
Postoperative 48 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 31, 2020

Primary Completion (ACTUAL)

January 30, 2021

Study Completion (ACTUAL)

February 15, 2021

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (ACTUAL)

June 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RISS THORACOTOMY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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