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Clinical Trials/NCT03508531
NCT03508531
Completed
Not Applicable

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

Maltepe University1 site in 1 country60 target enrollmentMarch 23, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Pain
Sponsor
Maltepe University
Enrollment
60
Locations
1
Primary Endpoint
Pain
Status
Completed
Last Updated
7 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.Oblique subcostal transverse abdominis plane block (OSTAP) 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 OSTAP in laparoscopic cholecystectomy.

Registry
clinicaltrials.gov
Start Date
March 23, 2018
End Date
May 21, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Asst. Prof. Serkan Tulgar, M.D.

Assistant proffessor

Maltepe University

Eligibility Criteria

Inclusion Criteria

  • Elective laparoscopic Cholecystectomy, ASA status 1-2 -

Exclusion Criteria

  • Patient refusal
  • Contraindications to regional anesthesia
  • Known allergy to local anesthetics
  • Bleeding diathesis
  • Use of any anti-coagulants
  • Inability to provide informed consent
  • Severe kidney or liver disease
  • Inability to operate PCA system
  • Patient with psychiatric disorders

Outcomes

Primary Outcomes

Pain

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(24 hours)

Study Sites (1)

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