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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-02-28

Brief Summary

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

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Detailed Description

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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.

Conditions

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Cholecystitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

USG guided Subcostal TAP block

Intervention Type PROCEDURE

Ultrasonography Assisted Subcostal TAP blockage: In plane technique was applied and 22 G needle (BRAUN Stimuplex D Plus 0,71\*50 mm 22G\*2) was used. Intravascular injection was eliminated after the passage of rectus sheath by negative aspiration. 0,5-1 ml local anesthetic was applied directly to confirm the right place. 10 cc bupivacain ( 0,5 % Marcain flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. The same procedure was applied to the opposite site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

USG guided Paravertebral Block

Intervention Type PROCEDURE

Ultrasonoraphy assisted Thoracic Paravertebral blockage application: In-plane or out-of-plane technique was used with stimuplex needle (BRAUN Stimuplec D Plus 0,71\*50 mm 22 G\* 2'', 15°). Popping sensation that was felt by the penetration of the internal intercostal membrane, guided to paravertebral space. Intravascular injection was eliminated by negative aspiration. 0,5 - 1 ml local anesthetic injection was administered to show the displacement of pleura downward that confirmed the place of the needle in the right place. Then 10 cc bupivacain (% 0.5 Marcaine® flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

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.

Group Type ACTIVE_COMPARATOR

USG guided Subcostal TAP block

Intervention Type PROCEDURE

Ultrasonography Assisted Subcostal TAP blockage: In plane technique was applied and 22 G needle (BRAUN Stimuplex D Plus 0,71\*50 mm 22G\*2) was used. Intravascular injection was eliminated after the passage of rectus sheath by negative aspiration. 0,5-1 ml local anesthetic was applied directly to confirm the right place. 10 cc bupivacain ( 0,5 % Marcain flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. The same procedure was applied to the opposite site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

USG guided Paravertebral Block

Intervention Type PROCEDURE

Ultrasonoraphy assisted Thoracic Paravertebral blockage application: In-plane or out-of-plane technique was used with stimuplex needle (BRAUN Stimuplec D Plus 0,71\*50 mm 22 G\* 2'', 15°). Popping sensation that was felt by the penetration of the internal intercostal membrane, guided to paravertebral space. Intravascular injection was eliminated by negative aspiration. 0,5 - 1 ml local anesthetic injection was administered to show the displacement of pleura downward that confirmed the place of the needle in the right place. Then 10 cc bupivacain (% 0.5 Marcaine® flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

Interventions

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USG guided Subcostal TAP block

Ultrasonography Assisted Subcostal TAP blockage: In plane technique was applied and 22 G needle (BRAUN Stimuplex D Plus 0,71\*50 mm 22G\*2) was used. Intravascular injection was eliminated after the passage of rectus sheath by negative aspiration. 0,5-1 ml local anesthetic was applied directly to confirm the right place. 10 cc bupivacain ( 0,5 % Marcain flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. The same procedure was applied to the opposite site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

Intervention Type PROCEDURE

USG guided Paravertebral Block

Ultrasonoraphy assisted Thoracic Paravertebral blockage application: In-plane or out-of-plane technique was used with stimuplex needle (BRAUN Stimuplec D Plus 0,71\*50 mm 22 G\* 2'', 15°). Popping sensation that was felt by the penetration of the internal intercostal membrane, guided to paravertebral space. Intravascular injection was eliminated by negative aspiration. 0,5 - 1 ml local anesthetic injection was administered to show the displacement of pleura downward that confirmed the place of the needle in the right place. Then 10 cc bupivacain (% 0.5 Marcaine® flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site.

we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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ILKE KUPELI

specialist dr

Responsibility Role PRINCIPAL_INVESTIGATOR