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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03815799
• Other study ID #: ESP-RF
• Status: Completed
• Phase: N/A
• Start date: March 3, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: January 2020
• Source: Konya Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Laparoscopic Cholecystectomy
• Pain, Postoperative
• Postoperative Pain
• Respiratory Function

Intervention

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).

Other:
• Control
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.

Locations

Country	Name	City	State
Turkey	Konya Education and Training Hospital	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Konya Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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

Outcome

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