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Rhomboid Intercostal and Subserratus Plane Block

Primary Purpose

Cholecystectomy, Postoperative Pain, Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
RIIS
Tramadol
Sponsored by
Bursa Yüksek İhtisas Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystectomy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study

Exclusion Criteria:

  • bleeding disorders,
  • mental incapacity,
  • known allergy to the local anesthetics,
  • body mass index ≥35 kg/m2

Sites / Locations

  • Bursa Yuksek Ihtisas Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

grup R

Group P

Arm Description

Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia

intravenous patient-controlled analgesia

Outcomes

Primary Outcome Measures

tramadol consumption
tramadol consumption

Secondary Outcome Measures

Numeric Rating Scale rest
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Numeric Rating Scale during movement
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
additional analgesic use
additional analgesic use
side effect profile
side effect profile (Nausea and vomiting)
sensorial dermatomal block-level
Dermatomal dispersion of sensorial block to the cold stimulus.

Full Information

First Posted
February 16, 2021
Last Updated
February 16, 2021
Sponsor
Bursa Yüksek İhtisas Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04761029
Brief Title
Rhomboid Intercostal and Subserratus Plane Block
Official Title
Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bursa Yüksek İhtisas Education and Research 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
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.
Detailed Description
In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Postoperative Pain, Nerve Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
retrospective
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
grup R
Arm Type
Active Comparator
Arm Description
Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia
Arm Title
Group P
Arm Type
Placebo Comparator
Arm Description
intravenous patient-controlled analgesia
Intervention Type
Other
Intervention Name(s)
RIIS
Intervention Description
unilateral Rhomboid intercostal and subserratus block
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
intravenous patient-controlled analgesia (tramadol)
Primary Outcome Measure Information:
Title
tramadol consumption
Description
tramadol consumption
Time Frame
Postoperative 24 hours
Secondary Outcome Measure Information:
Title
Numeric Rating Scale rest
Description
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
postoperative 24 hours
Title
Numeric Rating Scale during movement
Description
Numeric Rating Scale was used for pain.Pain intensity was measured using Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Postoperative 24 hours
Title
additional analgesic use
Description
additional analgesic use
Time Frame
Postoperative 24 hours
Title
side effect profile
Description
side effect profile (Nausea and vomiting)
Time Frame
Postoperative 24 hours
Title
sensorial dermatomal block-level
Description
Dermatomal dispersion of sensorial block to the cold stimulus.
Time Frame
30 minutes after the block administration and at the postoperative 2nd hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiology physical status I and II and who gave consent for the blocks were included in the study Exclusion Criteria: bleeding disorders, mental incapacity, known allergy to the local anesthetics, body mass index ≥35 kg/m2
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Korgün Ökmen, Assoc. PhD.
Organizational Affiliation
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa Yuksek Ihtisas Training and Research Hospital
City
Bursa
ZIP/Postal Code
16110
Country
Turkey

12. IPD Sharing Statement

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Rhomboid Intercostal and Subserratus Plane Block

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