Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

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

PHASE4

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-08-31

Brief Summary

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Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.

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Detailed Description

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In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.

Conditions

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Cholecystectomy, Laparoscopic Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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local infiltration

Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation

Group Type ACTIVE_COMPARATOR

Levobupivacaine 0.5%

Intervention Type DRUG

Control

Only routine general anesthesia will be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

TAP

Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.

Group Type EXPERIMENTAL

Levobupivacaine 0.25 %

Intervention Type DRUG

Interventions

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Levobupivacaine 0.25 %

Intervention Type DRUG

Levobupivacaine 0.5%

Intervention Type DRUG

Other Intervention Names

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chirocaine chirocaine

Eligibility Criteria

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Inclusion Criteria

* ASA I-II risk group,
* between the ages of 20-60,
* undergo elective laporoscopic cholecystectomy operation under general anesthesia

Exclusion Criteria

* allergy to anesthetic medication,
* coronary artery patients,
* obese patients,
* emergencies,
* pregnants,
* abdomen operation history
* heart block

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No