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Completed

NCT Number: NCT03543202

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

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

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Key information

Conditions

Biliary Disease Biliary Tract Diseases Digestive System Diseases Gallbladder Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diskapi Yıldırım Beyazıt EAH

Ankara, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transversus Abdominis Plane Block

Drug

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

local infiltration anesthesia

Drug

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

Intravenous patient controlled analgesia

Drug

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

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 1, 2018
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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