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Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT03543202
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital

Brief Summary:
Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction

Condition or disease Intervention/treatment Phase
Biliary Disease Drug: Transversus abdominis plane block Drug: local infiltration anesthesia Drug: Intravenous patient controlled analgesia Not Applicable

Detailed Description:

Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time)

Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: prospective randomised
Masking: Double (Participant, Outcomes Assessor)
Masking Description: patients and outcome assesors will be blinded for the analgesia method
Primary Purpose: Other
Official Title: Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy
Actual Study Start Date : June 10, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Transversus abdominis plane block
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
Drug: Transversus abdominis plane block
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Drug: Intravenous patient controlled analgesia
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Active Comparator: Local infiltration anesthesia
will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia
Drug: local infiltration anesthesia
will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia

Drug: Intravenous patient controlled analgesia
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia

Sham Comparator: Intravenous patient control analgesia
will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia
Drug: Intravenous patient controlled analgesia
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia




Primary Outcome Measures :
  1. Postoperative analgesia [ Time Frame: Postoperative day 1 ]
    Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain)


Secondary Outcome Measures :
  1. Postoperative nausea and vomiting (PONV) [ Time Frame: Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour ]
    PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more

  2. Patient satisfaction [ Time Frame: Postoperative 24 th hour ]
    Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

• Clinical diagnosis of biliary disease

Exclusion Criteria:

  • Uncooperative patients
  • Blood coagulation disorders
  • Laparatomy
  • Obesity: body mass index >35
  • Renal failure
  • Hepatic failure
  • Emergency surgery
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543202


Contacts
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Contact: Emine Arik, Dr +905333471530 emineincearik@yahoo.com

Locations
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Turkey
Diskapi Yıldırım Beyazıt EAH Recruiting
Ankara, Turkey
Contact: Emine Arık, DR         
Sponsors and Collaborators
Diskapi Yildirim Beyazit Education and Research Hospital
Investigators
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Principal Investigator: Emine Arik, Dr Ministry f Health

Publications of Results:
Other Publications:
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Responsible Party: Emine Arik, Specialist in Anesthesia, Diskapi Yildirim Beyazit Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03543202     History of Changes
Other Study ID Numbers: EmineTAP
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Emine Arik, Diskapi Yildirim Beyazit Education and Research Hospital:
Unilateral transversus abdominal plane block
Local infiltration anesthesia
Cholecystectomy
Postoperative analgesia

Additional relevant MeSH terms:
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Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Anesthetics
Bupivacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents