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Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039321
Recruitment Status : Completed
First Posted : July 31, 2019
Last Update Posted : December 23, 2019
Sponsor:
Information provided by (Responsible Party):
Arzu Karaveli, Antalya Training and Research Hospital

Tracking Information
First Submitted Date  ICMJE July 27, 2019
First Posted Date  ICMJE July 31, 2019
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE August 1, 2019
Actual Primary Completion Date December 4, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • 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.
  • analgesia consumption [ Time Frame: 24 hours ]
    postoperative 24 hours
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2019)
  • 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
  • arterial blood gases [ Time Frame: during the surgery ]
    intraoperative
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erector Spina Plane Block in Laparoscopic Sleeve Gastrectomy Surgery
Official Title  ICMJE The Effect of Erector Spina Plane Block on Pulmonary Functions and Analgesic Consumption in Laparoscopic Sleeve Gastrectomy Surgery
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Drug: ESPB group
    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.
  • Drug: Control group
    The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
Study Arms  ICMJE
  • Active Comparator: ESPB group
    Before anaesthesia induction; bilateral ESP block will be performed under the guidance of USG. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.
    Intervention: Drug: ESPB group
  • Sham Comparator: Control group
    Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. If patients' NRS score will ≥4/10, 100 mg IV tramadol will be performed.
    Intervention: Drug: Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 4, 2019
Actual Primary Completion Date December 4, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04039321
Other Study ID Numbers  ICMJE 13/22
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Arzu Karaveli, Antalya Training and Research Hospital
Study Sponsor  ICMJE Antalya Training and Research Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arzu Karaveli Antalya TRH
PRS Account Antalya Training and Research Hospital
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP