Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03719157
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2021
• Source: Diskapi Yildirim Beyazit Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Main purpose of this prospective single center randomized study is to compare the analgesic effect of ultrasound guided Unilateral Oblique Subcostal Transversus Abdominis Plane (TAP),unilateral Erector Spinae Plane (ESP) blocks and Port site infiltration of local anesthetic in subjects undergoing laparoscopic cholecystectomy. Total 100 patients, American society of anaesthesiology physical status I-II aged between 18-65 who underwent laparoscopic cholecystectomy will recruit to the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ASA Status 1-2 patients Exclusion criteria
• Patients with a body mass index (BMI) of >40kg/m2
• ASA score of >III
• Previous abdominal surgery
• Pregnant or breastfeeding patients
• Patients with coagulopathy
• Known local anesthetic allergy
• infection at the injection site

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

Procedure:
• Unilateral ESP Block
USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture
• Unilateral OSTAP Block
USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
• Injection of Local Anesthetic to Trocar Insertion
Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.

Drug:
• intravenous patient controlled analgesia
All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.

Locations

Country	Name	City	State
Turkey	Diskapi education and research hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Yildirim Beyazit Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.	24 hours
Primary	Postoperative pain scores: NRS	Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.	24 hours
Secondary	postoperative nause and vomiting	The patient with nausea and vomiting will be recorded.	24 hours