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Clinical Trials/NCT05837702
NCT05837702
Completed
Not Applicable

Comparison of the Effects of Erector Spina Plan Block and Paravertebral Block in Laparoscopic Cholecystectomies on Pain Management.

Giresun University1 site in 1 country90 target enrollmentJanuary 10, 2022
ConditionsNerve Block

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Nerve Block
Sponsor
Giresun University
Enrollment
90
Locations
1
Primary Endpoint
Total tramadol consumption
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Erector spinae plane (ESP) block is a more recent method than paravertebral block (PVB) and has a lower risk of complications. The aim of this study was to compare postoperative analgesia requirements and side-effects in terms of safely reaching the maximum analgesic effect in patients.

Detailed Description

The primary aim of this study was to compare ESP block and PVB as important postoperative pain management in terms of being able to reliably reach the highest analgesic efficacy in patients who underwent laparoscopic surgery which is a frequently applied surgery. The secondary aim was to determine the incidence of postoperative nausea, vomiting and side-effects, and patient satisfaction.

Registry
clinicaltrials.gov
Start Date
January 10, 2022
End Date
January 10, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elvan Yilmaz

Assistant Professor

Giresun University

Eligibility Criteria

Inclusion Criteria

  • aged \>18 years
  • patients with the American Society of Anesthesiologists (ASA) physical status I/II -who were planned to undergo laparoscopic cholecystectomy surgery

Exclusion Criteria

  • Did not provide informed consent,
  • Had any psychiatric or mental problem that prevented understanding of the informed consent form
  • They were planned to undergo emergency cholecystectomy,
  • Had any allergy or hypersensitivity to local anaesthetic,
  • Had an infection in the needle entry area
  • History of coagulopathy or the use of anticoagulants

Outcomes

Primary Outcomes

Total tramadol consumption

Time Frame: 24 hours postoperatively

Consumption at the end of 24 hours will be monitored by planning a 10mg bolus, a 10-minute lock-in time, through a patient-controlled analgesia device.

Secondary Outcomes

  • Visual analog scale (VAS) at rest and when coughing(at 0, 5, 10,20 minutes and 1, 2,4 , 6, 12 and 24 hours postoperatively)
  • Analgesic drug consumption other than tramadol(24 hours postoperatively)
  • Heart Rate(preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes))
  • Mean arterial pressure (MAP)(preoperative, after insufflation, after exsufflation, after extubation( 5,10,20,30 minutes))
  • Incidence of postoperative nausea & vomiting (PONV)(24 hours postoperatively)
  • Shoulder pain(24 hours postoperatively)

Study Sites (1)

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