Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Recovery
• Intervention / Treatment: Other: local anesthetic injection; Other: Standard perioperative and postoperative analgesia protocol.

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • Konya Education and Training Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ESP Group; 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.	Other: local anesthetic injection; A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic mixture will be injected bilaterally into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).
OTHER: Control; Patients will receive standard perioperative and postoperative analgesia protocol.	Other: Standard perioperative and postoperative analgesia protocol.; Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive contramal 1 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Recovery (QoR-40) score	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.	postoperative 24 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Konya Meram State Hospital
• Investigators: Principal Investigator: Ahmet Canıtez, M.D.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2019
• Primary Completion (ACTUAL): March 20, 2020
• Study Completion (ACTUAL): April 4, 2020

Study Registration Dates

• First Submitted: September 30, 2019
• First Submitted That Met QC Criteria: September 30, 2019
• First Posted (ACTUAL): October 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2020
• Last Update Submitted That Met QC Criteria: April 4, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local
• Other Study ID Numbers: ESP-Quality of Recovery

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No