Clinical trial NCT04112394: Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy
Official title: Evaluation of Postoperative Pain and Recovery Quality (QoR-40) in Patients Undergoing Erector Spinal Area (ESP) Block After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Recovery
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2019-10-02
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Quality of Recovery (QoR-40) score
timeFrame: postoperative 24 hour
Secondary outcomes:
measure: Postoperative pain: numeric rating scale (NRS)
timeFrame: Postoperative 24 hours
measure: Analgesic consumption
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya Education and Training Hospital
Study officials:
affiliation: M.D.
name: Ahmet Canıtez
role: PRINCIPAL_INVESTIGATOR
References:
citation: Canitez A, Kozanhan B, Aksoy N, Yildiz M, Tutar MS. Effect of erector spinae plane block on the postoperative quality of recovery after laparoscopic cholecystectomy: a prospective double-blind study. Br J Anaesth. 2021 Oct;127(4):629-635. doi: 10.1016/j.bja.2021.06.030. Epub 2021 Jul 31.