Clinical trial NCT02379780: Ultrasound Guided Subcostal Transversus Abdominis Plane Versus Paravertebral Block in the Laparoscopic Cholecystectomy
Official title: Comparison of the Effects of Perioperative Anesthesia Consumption of Ultrasound Guided Subcostal Transversus Abdominis Plane and Paravertebral Block in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholecystitis
Lead sponsor: Cukurova University
Sponsor class: OTHER
Collaborators: name: Erzincan University
First posted: 2015-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: anesthetic and opioid consumption during operation
timeFrame: six months
Secondary outcomes:
measure: postoperative VAS scores
timeFrame: six months
measure: duration of analgesia
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: ILKE KUPELI
role: PRINCIPAL_INVESTIGATOR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: ZEHRA BEDİR
role: STUDY_CHAIR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: HUSEYIN EKEN
role: STUDY_CHAIR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: UFUK KUYRUKLUYILDIZ
role: STUDY_CHAIR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: DIDEM ONK
role: STUDY_CHAIR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: ORHAN BINICI
role: STUDY_CHAIR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: AYSIN ALAGOL
role: STUDY_DIRECTOR
affiliation: MENGUCEK GAZI TRAINING AND RESEARCH HOSPİTAL
name: GULDANE KARABAKAN
role: STUDY_CHAIR
References:
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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 cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17.
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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.
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