Rhomboid Intercostal and Subserratus Plane Block

February 16, 2021 updated by: Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Investigation of the Efficacy of Unilateral Rhomboid Intercostal and Subserratus Plane Block Application for Postoperative Analgesia in Laparoscopic Cholecystectomy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, the analgesic efficacy of Unilateral Rhomboid intercostal and subserratus block was investigated in patients who had laparoscopic cholecystectomy.

Study Type

Interventional

Enrollment (Actual)

50

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
      • Bursa, Turkey, 16110
        • Bursa Yuksek Ihtisas Training and Research 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

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: grup R
Unilateral Rhomboid intercostal and subserratus block + intravenous patient-controlled analgesia
Other: RIIS
unilateral Rhomboid intercostal and subserratus block
Drug: Tramadol
intravenous patient-controlled analgesia (tramadol)
Placebo Comparator: Group P
intravenous patient-controlled analgesia
Drug: Tramadol
intravenous patient-controlled analgesia (tramadol)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tramadol consumption
Time Frame: Postoperative 24 hours
tramadol consumption
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
additional analgesic use
Time Frame: Postoperative 24 hours
additional analgesic use
Postoperative 24 hours
Numeric Rating Scale rest
Time Frame: postoperative 24 hours
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).
postoperative 24 hours
Numeric Rating Scale during movement
Time Frame: Postoperative 24 hours
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).
Postoperative 24 hours
side effect profile
Time Frame: Postoperative 24 hours
side effect profile (Nausea and vomiting)
Postoperative 24 hours
sensorial dermatomal block-level
Time Frame: 30 minutes after the block administration and at the postoperative 2nd hour
Dermatomal dispersion of sensorial block to the cold stimulus.
30 minutes after the block administration and at the postoperative 2nd hour

Collaborators and Investigators

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

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

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)

January 1, 2018

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

July 1, 2020

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25

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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