The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

Overview

The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2019

Interventions

  • Procedure: Bilateral Erector Spinae Block
    • A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected 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
    • 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 meperidine 0.5 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.

Arms, Groups and Cohorts

  • Experimental: Erector Spinae Plane Block Group
    • Procedure: In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.
  • Sham Comparator: Control
    • Routine standard perioperative and postoperative analgesic protocol will be given.

Clinical Trial Outcome Measures

Primary Measures

  • Scoring of postoperative pain
    • Time Frame: Postoperative 24 hour
    • The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).

Secondary Measures

  • Analgesic consumption
    • Time Frame: Postoperative 24 hour
    • Total opioid consumption after the operation
  • Spirometric Parameters of Respiratory Functions
    • Time Frame: Preoperative (before the surgery) and at postoperative 24th hour
    • Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)
  • Number of Adverse events
    • Time Frame: Postoperative 24 hour
    • Postoperative nausea and vomiting incidents at PACU and and at ward.

Participating in This Clinical Trial

Inclusion Criteria

• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

  • Patients refusal
  • Contraindications for regional anesthesia
  • Alcohol or drug abuse
  • Chronic opioid intake
  • Patient with psychiatric disorders
  • Use of pain killers within the 24 h before the operation
  • Respiratory tract infection within the last 2 weeks
  • Smoker or history of smoking
  • Allergy to local anesthetics
  • Respiratory and allergic diseases
  • Cardiac disease associated with dyspnea

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Konya Training and Research Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Asst. Prof. Munıse Yıldız M.D., Ass.Prof. – Konya Training and Research Hospital

References

Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

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