Comparison of OSTAP, ESP Block,Injection of Local Anesthetic to Trocar Insertion for Elective Laparoscopic Cholecystectomy
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Unilateral ESP Block Before general anaesthesia, Ultrasound guided unilateral ESP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. |
Procedure: Unilateral ESP Block
USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture
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.
|
| Active Comparator: Unilateral OSTAP block Under general anaesthesia, Ultrasound guided unilateral OSTAP block will perform with 15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. |
Procedure: Unilateral OSTAP Block
USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
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.
|
| Active Comparator: Injection of Local Anesthetic to Trocar Insertion After the laparoscopic surgery was completed, the trocar incision sites were closed. Following the infiltration rules, local anesthetic (15 ml of 0.5% bupivacaine and 5 ml 2% lidocaine) was applied to the trocar sites of skin, fascia, muscle, and preperitoneal area by the surgical team after the operation. A total of 20 mL of local anesthetic was used, with 6 mL for trocar sites of 10 mm, and 4 mL for trocar sites of 5 mm .Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. |
Procedure: 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.
|
| Sham Comparator: multimodal analgesia Perioperative and postoperative routine analgesic protocol will be performed with no additional regional anesthesia method.Patient controlled analgesia (PCA) with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours. |
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.
|
Outcome Measures
Primary Outcome Measures
- Postoperative opioid consumption [24 hours]
Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours.
- Postoperative pain scores: NRS [24 hours]
Postoperative pain assessment will apply with numerical rating scale. These scores will record till the postoperative 24 th hours.
Secondary Outcome Measures
- postoperative nause and vomiting [24 hours]
The patient with nausea and vomiting will be recorded.
Eligibility Criteria
Criteria
Inclusion Criteria:
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ASA Status 1-2 patients Exclusion criteria
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Patients with a body mass index (BMI) of >40kg/m2
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ASA score of >III
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Previous abdominal surgery
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Pregnant or breastfeeding patients
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Patients with coagulopathy
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Known local anesthetic allergy
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infection at the injection site
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diskapi education and research hospital | Ankara | Turkey | 06010 |
Sponsors and Collaborators
- Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1