Postoperative Pain Clinical Trial
Official title:
The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
NCT number | NCT03815799 |
Other study ID # | ESP-RF |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 3, 2019 |
Est. completion date | September 30, 2019 |
Verified date | January 2020 |
Source | Konya Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | September 30, 2019 |
Est. primary completion date | September 30, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Konya Education and Training Hospital | Konya |
Lead Sponsor | Collaborator |
---|---|
Konya Training and Research Hospital |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Scoring of postoperative pain | 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). | Postoperative 24 hour | |
Secondary | Analgesic consumption | Total opioid consumption after the operation | Postoperative 24 hour | |
Secondary | Spirometric Parameters of Respiratory Functions | Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR) | Preoperative (before the surgery) and at postoperative 24th hour | |
Secondary | Number of Adverse events | Postoperative nausea and vomiting incidents at PACU and and at ward. | Postoperative 24 hour |
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