Rhomboid Intercostal and Subserratus Plane Block
Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy
1 other identifier
interventional
50
1 country
1
Brief Summary
Laparoscopic surgery is frequently used today for abdominal region operations. Laparoscopy has become the preferred treatment for cholecystectomy. Patients undergoing laparoscopic cholecystectomy suffer from acute postoperative pain despite the multimodal analgesic regimen. For this type of surgery, many different field blocks have been used for postoperative analgesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 16, 2021
CompletedFirst Posted
Study publicly available on registry
February 18, 2021
CompletedFebruary 18, 2021
February 1, 2021
2.5 years
February 16, 2021
February 16, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
tramadol consumption
tramadol consumption
Postoperative 24 hours
Secondary Outcomes (5)
Numeric Rating Scale rest
postoperative 24 hours
Numeric Rating Scale during movement
Postoperative 24 hours
additional analgesic use
Postoperative 24 hours
side effect profile
Postoperative 24 hours
sensorial dermatomal block-level
30 minutes after the block administration and at the postoperative 2nd hour
Study Arms (2)
grup R
ACTIVE COMPARATORUnilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia
Group P
PLACEBO COMPARATORintravenous patient-controlled analgesia
Interventions
Eligibility Criteria
You may qualify if:
- American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study
You may not qualify if:
- bleeding disorders,
- mental incapacity,
- known allergy to the local anesthetics,
- body mass index ≥35 kg/m2
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16110, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Korgün Ökmen, Assoc. PhD.
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator ,Assoc. PhD. M.D.
Study Record Dates
First Submitted
February 16, 2021
First Posted
February 18, 2021
Study Start
January 1, 2018
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 18, 2021
Record last verified: 2021-02