Back to resultsEffect of Continue RISS Block in Thoracotomy
Primary Purpose
Postoperative Pain, Thoracotomy
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tramadol
IV PCA
Sponsored by
About this trial
This is an interventional other trial for Postoperative Pain
Eligibility Criteria
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
Sites / Locations
- Konya Education and Training Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Group Rhomboid Intercostal and Subserratus Plane Block
Control Group
Arm Description
Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block
Standart postoperative analgesia
Outcomes
Primary Outcome Measures
postoperative pain
Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
Secondary Outcome Measures
Analgesic consumption
Total opioid consumption after the surgery
Full Information
NCT ID
NCT04443556
First Posted
June 20, 2020
Last Updated
April 18, 2021
Sponsor
Konya Meram State Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04443556
Brief Title
Effect of Continue RISS Block in Thoracotomy
Official Title
Effect of Continue Rhomboid Intercostal and Subserratus Plane Block in Thorocotomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
August 31, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
February 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Thoracotomy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Rhomboid Intercostal and Subserratus Plane Block
Arm Type
Active Comparator
Arm Description
Standart postoperative analgesia + Continue Rhomboid Intercostal and Subserratus Plane Block
Arm Title
Control Group
Arm Type
Other
Arm Description
Standart postoperative analgesia
Intervention Type
Drug
Intervention Name(s)
Tramadol
Other Intervention Name(s)
Local anesthetic
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
IV PCA
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
Numeric rating scale (NRS) NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
Time Frame
postoperative 48 hour
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Total opioid consumption after the surgery
Time Frame
Postoperative 48 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Konya Education and Training Hospital
City
Konya
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
36218395
Citation
Kozanhan B, Semerkant T, Esme H, Canitez A, Iyisoy MS. Evaluation of rhomboid intercostal and subserratus plane block under direct vision for postoperative analgesia in thoracic surgeries: a prospective, randomized controlled trial. Eur J Cardiothorac Surg. 2022 Nov 3;62(6):ezac498. doi: 10.1093/ejcts/ezac498.
Results Reference
derived
Learn more about this trial
Effect of Continue RISS Block in Thoracotomy
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