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Clinical Trials/NCT04112394
NCT04112394
Completed
Not Applicable

Evaluation of Postoperative Pain and Recovery Quality (QoR-40) in Patients Undergoing Erector Spinal Area (ESP) Block After Laparoscopic Cholecystectomy

Konya Meram State Hospital1 site in 1 country82 target enrollmentSeptember 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Recovery
Sponsor
Konya Meram State Hospital
Enrollment
82
Locations
1
Primary Endpoint
Quality of Recovery (QoR-40) score
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The primary aim of this prospective, randomized study is to evaluate the effect of erector spinae block (ESP) on quality of recovery with the QoR-40 questionnaire in patients undergoing elective laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy, one of the most common general surgical procedures, is the gold standard for the treatment of symptomatic gallbladder diseases. Although it is considered as minimally invasive surgery, pain in the early postoperative period is still meaningful. Proper pain control is essential for optimizing clinical outcomes and earlier ambulation after surgery. Traditional pain management with opioids provide good pain control, however, have undesirable side effects such as nausea, vomiting, and respiratory depression. Multimodal analgesia strategies with different classes of analgesics or local anesthetics may enhance pain relief and reduce side effects after surgery. The ESP a newer regional nerve blockade, has been used as part of a multimodal strategy to optimize postoperative pain control. The primary aim of this study is to evaluate the effect of ESP block on postoperative recovery quality in patients undergoing laparoscopic cholecystectomy with QoR-40 recovery questionnaire. Secondary aim is to assess the effect of ESP block on postoperative pain, nausea, and vomiting. Study hypothesize is that patients who receive an ESP block in addition to the current standard of care, consisting of parenteral opioids and paracetamol, will have a clinically significant improvement in their QoR-40 at postoperative day 1 and lower pain levels, as measured by NRS in comparison to those patients who receive the current standard of care along.

Registry
clinicaltrials.gov
Start Date
September 29, 2019
End Date
April 4, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Betul Kozanhan

Ass.Prof.

Konya Meram State Hospital

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiology (ASA) physical status I-II
  • Scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

  • a history of allergy to local anesthetics
  • known coagulation disorders
  • infection near the puncture site
  • Chronic opioid intake
  • Patient with psychiatric disorders
  • inability to communicate

Outcomes

Primary Outcomes

Quality of Recovery (QoR-40) score

Time Frame: postoperative 24 hour

QoR-40, a 40-item questionnaire that provides a global score and subscores across five dimensions: patient support, comfort, emotions, physical independence, and pain. Each item is rated on a scale of 1-5, providing a minimum score of 40 and maximum of 200.

Secondary Outcomes

  • Postoperative pain: numeric rating scale (NRS)(Postoperative 24 hours)
  • Analgesic consumption(Postoperative 24 hour)

Study Sites (1)

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