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Clinical Trials/NCT04116008
NCT04116008
Completed
Not Applicable

Evaluation of Postoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block and Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy, Randomised Controlled Study

Baskent University1 site in 1 country70 target enrollmentNovember 10, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Baskent University
Enrollment
70
Locations
1
Primary Endpoint
Pain Score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic Subcostal transverse abdominis plane block (STAP) is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and STAP in laparoscopic cholecystectomy.

Registry
clinicaltrials.gov
Start Date
November 10, 2019
End Date
December 24, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Omer Karaca

Director

Baskent University

Eligibility Criteria

Inclusion Criteria

  • ASA I-II-III
  • Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria

  • infection of the skin at the site of needle puncture area
  • patients with known allergies to any of the study drugs
  • coagulopathy
  • recent use of analgesic drugs
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

Outcomes

Primary Outcomes

Pain Score

Time Frame: 24 hours

Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Secondary Outcomes

  • analgesic consumption(at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours)
  • block related complication(in this block performing time, till patients anesthetized right after block procedure, at PACU, 2nd, 4th, 6th, 12th and 24th hours)
  • opioid complication(at PACU (postanesthetic care unit), 2nd, 4th, 6th, 12th and 24th hours)

Study Sites (1)

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