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

Diskapi Yildirim Beyazit Training and Research Hospital

Status: Completed

Conditions: Postoperative Pain; Regional Anesthesia

Treatments: Procedure: Unilateral ESP Block; Procedure: Unilateral OSTAP Block; Drug: intravenous patient controlled analgesia; Procedure: Injection of Local Anesthetic to Trocar Insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT03719157

1

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Unilateral ESP Block

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous patient controlled analgesia

Procedure: Unilateral ESP Block

Unilateral OSTAP block

Active Comparator group

Description:

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.

Treatment:

Drug: intravenous patient controlled analgesia

Procedure: Unilateral OSTAP Block

Injection of Local Anesthetic to Trocar Insertion

Active Comparator group

Description:

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.

Treatment:

Procedure: Injection of Local Anesthetic to Trocar Insertion

Drug: intravenous patient controlled analgesia

multimodal analgesia

Sham Comparator group

Description:

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.

Treatment:

Drug: intravenous patient controlled analgesia