Does Erector Spinal Block Improve Quality of Recovery After Laparoscopic Cholecystectomy

NCT04112394 | Completed

• 1 other identifier: ESP-Quality of Recovery
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative pain: numeric rating scale (NRS)

  Postoperative 24 hours

• Analgesic consumption

  Postoperative 24 hour

Study Arms (2)

ESP Group

EXPERIMENTAL

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

Control

OTHER

Patients will receive standard perioperative and postoperative analgesia protocol.

Other: Standard perioperative and postoperative analgesia protocol.

Interventions

local anesthetic injection OTHER

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).

ESP Group

Standard perioperative and postoperative analgesia protocol. OTHER

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.

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Konya Meram State Hospital: lead

Study Sites (1)

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 34340839 DERIVED

MeSH Terms

Interventions

Anesthetics, Local

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Ahmet Canıtez

  M.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Prof.

Study Record Dates

• First Submitted: September 30, 2019
• First Posted: October 2, 2019
• Study Start: September 29, 2019
• Primary Completion: March 20, 2020
• Study Completion: April 4, 2020
• Last Updated: April 7, 2020

Record last verified: 2020-04

Locations

TU (1)