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Completed

NCT Number: NCT03815799

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

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.

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Key information

Conditions

Laparoscopic Cholecystectomy Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Respiration Disorders Respiratory Aspiration Respiratory Function Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Konya Education and Training Hospital

Konya, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bilateral erector spinae block

Procedure

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).

Control

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 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.

Primary outcomes

  1. 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 outcomes

  1. Analgesic consumption

    Time frame: Postoperative 24 hour

    Total opioid consumption after the operation

  2. 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)

  3. Number of Adverse events

    Time frame: Postoperative 24 hour

    Postoperative nausea and vomiting incidents at PACU and and at ward.

Sponsors and collaborators

Lead sponsor

Konya Meram State Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2019
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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