Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Cholecystitis
• Interventions: Procedure: USG guided Subcostal TAP block; Procedure: USG guided Paravertebral Block

• Registration Number: NCT02379780
• Lead Sponsor: Cukurova University

Brief Summary

The investigators aimed to compare the effects of perioperative anesthesia consumption of ultrasound guided subcostal transversus abdominis plane and paravertebral block in laparoscopic cholecystectomy.

Detailed Description

Fifty patients aged 18 - 65 years, American Society of Anesthesiologists (ASA) I-II-III, scheduled for laparoscopic cholecystectomy were enrolled into the study. Patients were allocated into two groups to receive ultrasound guided subcostal transversus abdominis plane block (group T, n=25) or ultrasound guided paravertebral block (group P, n=25). In all patients; anesthesia was induced with iv propofol (2 mg.kg-1) and maintained with total intravenous anesthesia (TIVA) in a mixture of 50 % nitrous oxide and 50 % oxygen with a total gas flow rate of 4 L min-1. Neuromuscular relaxation was induced with iv rocuronium (0.5 mg.kg-1). Propofol (2 mg / cc, 2-4 mg / kg / h) and remifentanil (13.3 mcg / cc, 1-3 mcg / kg / h) combination was used in TIVA. Propofol and remifentanil rates increased or reduced according to the patient's hemodynamic response. Prior to start surgery, ultrasound guided subcostal transversus abdominis plane or paravertebral block was performed in patients .

Blood pressure, heart rate and peripheral oxygen saturation,TIVA consumption of 0, 5, 10, 15, 30, 60 min were recorded for all patients.Before the end of surgery, tramadol was administered (2 mg / kg) for all patients.

All patients were evaluated at postoperative 2th, 4th, 8th, 12th, 24th hours with; operation time, heart rate, blood pressure, peripheral oxygen saturation, visual pain scores (VAS), analgesic consumption, complications (hypotension, anaphylaxis, hematoma, IV injection, intra-abdominal organ injury, pneumothorax ) and patient satisfaction status were recorded. In the postoperative period if there is additional analgesic requirements (VAS≥4) tramadol 2 mg.kg-1 was administered as IV. The first hour is needed analgesia were recorded.

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Study First Submitted: 2015-02-19
• Status Verified: 2015-03
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-05
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Between 18-65 years of age,
• ASA I-II-III
• laparoscopic cholecystectomy to be applied

Exclusion Criteria

• patient refusal
• mental and psychiatric disorders,
• allergy history of the drug to be used,
• kyphoscoliotic anatomical disorder
• patients with coagulopathies

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
USG guided Subcostal TAP block	USG guided Subcostal TAP block	after preparing the skin, ultrasound probe was placed obliquely on the upper abdominal wall along the subcostal margin near the midline. the rectus abdominis muscles, transversus abdominis muscles and the fascial plane (TAP) between rectus abdominis and transversus abdominis muscles were identified. after identification, the block needle was introduced anteriorly in the plane of the ultrasound beam. the needle was directed the transversus abdominis plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.
USG guided Paravertebral Block	USG guided Paravertebral Block	prior to start surgery, was performed in the left lateral position. after preparing skin, ultrasound linear probe was placed, 2-3 cm lateral of the T7 / T8 level in the midline. After determining the transverse process and ribs as hyperechoic, the paravertebral space was identified as an area wedge-shaped bounded by the pleura and above the internal intercostal membrane.after identification of the paravertebral space, the block needle was introduced in plane / out of plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.
USG guided Subcostal TAP block	USG guided Paravertebral Block	after preparing the skin, ultrasound probe was placed obliquely on the upper abdominal wall along the subcostal margin near the midline. the rectus abdominis muscles, transversus abdominis muscles and the fascial plane (TAP) between rectus abdominis and transversus abdominis muscles were identified. after identification, the block needle was introduced anteriorly in the plane of the ultrasound beam. the needle was directed the transversus abdominis plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.
USG guided Paravertebral Block	USG guided Subcostal TAP block	prior to start surgery, was performed in the left lateral position. after preparing skin, ultrasound linear probe was placed, 2-3 cm lateral of the T7 / T8 level in the midline. After determining the transverse process and ribs as hyperechoic, the paravertebral space was identified as an area wedge-shaped bounded by the pleura and above the internal intercostal membrane.after identification of the paravertebral space, the block needle was introduced in plane / out of plane and 10 ml of bupivacaine (Marcaine 0,25 %) and 5 ml of lidocaine (2%) was injected after negative aspiration.

Primary Outcome Measures

Name	Time	Method
anesthetic and opioid consumption during operation	six months

Secondary Outcome Measures

Name	Time	Method
postoperative VAS scores	six months
duration of analgesia	six months