Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Postoperative Recovery
• Interventions: Other: Standard perioperative and postoperative analgesia protocol.; Other: local anesthetic injection

• Registration Number: NCT04112394
• Lead Sponsor: Konya Meram State Hospital

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.

Study Timeline

• Study Start: 2019-09-29
• Study First Submitted: 2019-09-30
• Study First Submitted QC: 2019-09-30
• Study First Posted: 2019-10-02
• Primary Completion: 2020-03-20
• Status Verified: 2020-04
• Study Completion: 2020-04-04
• Last Update Submitted: 2020-04-04
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard perioperative and postoperative analgesia protocol.	Patients will receive standard perioperative and postoperative analgesia protocol.
ESP Group	local anesthetic injection	In addition to routine standard perioperative and postoperative analgesia protocol patients will receive a single shot of local anesthetic injection at the erector spinae plane.

Primary Outcome Measures

Name	Time	Method
Quality of Recovery (QoR-40) score	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 Outcome Measures

Name	Time	Method
Postoperative pain: numeric rating scale (NRS)	Postoperative 24 hours	NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).
Analgesic consumption	Postoperative 24 hour	Total opioid consumption after the surgery

Trial Locations

Locations (1)

Konya Education and Training Hospital; 🇹🇷 Konya, Turkey