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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02379780
Other study ID # mengücek gazi hospital
Secondary ID
Status Completed
Phase N/A
First received February 19, 2015
Last updated March 5, 2015
Start date September 2014
Est. completion date February 2015

Study information

Verified date March 2015
Source Cukurova University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.


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 (VASā‰„4) tramadol 2 mg.kg-1 was administered as IV. The first hour is needed analgesia were recorded.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Cukurova University Erzincan University

References & Publications (8)

Aveline C, Le Hetet H, Le Roux A, Vautier P, Cognet F, Vinet E, Tison C, Bonnet F. Comparison between ultrasound-guided transversus abdominis plane and conventional ilioinguinal/iliohypogastric nerve blocks for day-case open inguinal hernia repair. Br J A — View Citation

Cheema SP, Ilsley D, Richardson J, Sabanathan S. A thermographic study of paravertebral analgesia. Anaesthesia. 1995 Feb;50(2):118-21. — View Citation

El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic ch — View Citation

Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. — View Citation

Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for analgesia after Cesarean delivery: a systematic review and meta-analysis. Can J Anaesth. 2012 Aug;59(8):766-78. doi: 10.1007/s12630-012-9729-1. Epub 2012 May 24. Review. — View Citation

Ozkan D, Akkaya T, Cömert A, Balkc N, Ozdemir E, Gümüs H, Ergül Z, Kaya O. Paravertebral block in inguinal hernia surgeries: two segments or 4 segments? Reg Anesth Pain Med. 2009 Jul-Aug;34(4):312-5. doi: 10.1097/AAP.0b013e3181ae1169. — View Citation

Thavaneswaran P, Rudkin GE, Cooter RD, Moyes DG, Perera CL, Maddern GJ. Brief reports: paravertebral block for anesthesia: a systematic review. Anesth Analg. 2010 Jun 1;110(6):1740-4. doi: 10.1213/ANE.0b013e3181da82c8. Epub 2010 May 6. Review. — View Citation

Williams SR, Chouinard P, Arcand G, Harris P, Ruel M, Boudreault D, Girard F. Ultrasound guidance speeds execution and improves the quality of supraclavicular block. Anesth Analg. 2003 Nov;97(5):1518-23. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary anesthetic and opioid consumption during operation six months No
Secondary postoperative VAS scores six months No
Secondary duration of analgesia six months No
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