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NCT Number: NCT04039321

Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery.

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Key information

Conditions

Obesity Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation

Antalya, 07100, Turkey (Türkiye)

About this study

Optimal pain management is very important in obese patients. In the postoperative period, narcotic analgesics are often used to pain management. However, the use of narcotic analgesics in the postoperative period causes many undesirable adverse effects, especially sedation, dizziness, constipation, nausea, vomiting, muscle rigidity, tolerance, and respiratory depression.

The morbidly obese patients treated with narcotic analgesics increased risk for adverse effects such as atelectasis, hypoxemia, and postoperative ileus. Consequently, these are caused postoperative pulmonary complications, hypoxemia and longer lenght of hospital stay. Multimodal analgesia including local and regional anesthesia is recommended for morbidly obese patients.

In recent years, the ultrasound (USG) guided ESP block has been frequently used to eliminate postoperative pain and reduce narcotic analgesic use. In the literature, it has been shown that bilateral USG guided ESP block provides effective analgesia and decrease the analgesia requirements after laparoscopic cholecystectomy. Some case series and case reports has also been reported that ESP block provides effective analgesia after abdominal and bariatric surgeries.

The aim of the study is to evaluate the effect of erector spina plane (ESP) block on pulmonary functions and postoperative analgesic consumption in patients undergoing bariatric surgery. For this purpose, ASA II-III, patients over 18 years of age, BMI 40-60 kg/m2 and elective bariatric surgery planned patients will be included in the study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiology (ASA) II-III
  • 18-65 years
  • body mass index (BMI) 40-60 kg/m2
  • elective bariatric surgery

Exclusion criteria

  • ASA ≥4
  • under 18 years of age or over 65 years of age
  • declining to give written informed consent
  • have neurological and/or psychiatric disorders
  • cooperation cannot be established
  • accompanying laparoscopic cholecystectomy or paraumbilical hernia repair
  • history of bariatric surgery
  • the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
  • with hepatic, neuromuscular, cardiac and/or renal failure
  • history of allergy to the local anesthetics
  • patients undergoing open surgery
  • patients with severe obstructive or restrictive lung disease

Treatment and study plan

ESPB group

Drug

USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an outplane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.

Control group

Drug

The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.

Primary outcomes

  1. pulmonary function test

    Time frame: perioperative

    Pulmonary function test will be performed for all of them in the day before operation and 24 hours after the operation. Pulmonary function tests will assess via a portable spirometer with the patient in the sitting or semi-recumbent position.

  2. analgesia consumption

    Time frame: 24 hours

    postoperative 24 hours

Secondary outcomes

  1. Postoperative Numeric Rating Scale (NRS) score

    Time frame: postoperative 0, 1, 3, 6, 9, 12, 18, 24 hours

    postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). The NRS scores will be recorded at postoperative 0, 1, 3, 6, 9, 12, 18 and 24 hours

  2. arterial blood gases

    Time frame: during the surgery

    intraoperative

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Official study title

The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 31, 2019
Registry last updated
Dec 23, 2019

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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