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Clinical Trials/NCT03543202
NCT03543202
Completed
Not Applicable

Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy

Diskapi Yildirim Beyazit Education and Research Hospital1 site in 1 country72 target enrollmentJune 10, 2018

Overview

Phase
Not Applicable
Intervention
Transversus abdominis plane block
Conditions
Biliary Disease
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Enrollment
72
Locations
1
Primary Endpoint
Postoperative analgesia
Status
Completed
Last Updated
last year

Overview

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

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.

Registry
clinicaltrials.gov
Start Date
June 10, 2018
End Date
May 30, 2019
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Emine Arik

Specialist in Anesthesia

Diskapi Yildirim Beyazit Education and Research Hospital

Eligibility 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

Arms & Interventions

Transversus abdominis plane block

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Intervention: Transversus abdominis plane block

Transversus abdominis plane block

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

Intervention: Intravenous patient controlled analgesia

Local infiltration anesthesia

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

Intervention: local infiltration anesthesia

Local infiltration anesthesia

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

Intervention: Intravenous patient controlled analgesia

Intravenous patient control analgesia

will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia

Intervention: Intravenous patient controlled analgesia

Outcomes

Primary Outcomes

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 Outcomes

  • Patient satisfaction(Postoperative 24 th hour)
  • Postoperative nausea and vomiting (PONV)(Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour)

Study Sites (1)

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