The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
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|ClinicalTrials.gov Identifier: NCT03815799|
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Laparoscopic Cholecystectomy Postoperative Pain Respiratory Function||Procedure: Bilateral Erector Spinae Block Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||68 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy|
|Actual Study Start Date :||March 3, 2019|
|Actual Primary Completion Date :||September 30, 2019|
|Estimated Study Completion Date :||September 30, 2019|
Experimental: Erector Spinae Plane Block Group
In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.
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).
Sham Comparator: Control
Routine standard perioperative and postoperative analgesic protocol will be given.
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.
- 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).
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815799
|Contact: Betul Kozanhan, Ass. Prof.||+email@example.com|
|Konya Education and Training Hospital||Recruiting|
|Contact: munise yıldız, M.D. firstname.lastname@example.org|