Skip to main content
OpenTrials
Completed

NCT Number: NCT02185716

Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cholecystectomy, Laparoscopic Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duzce University Medical Faculty

Düzce, 81160, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Levobupivacaine 0.25 %

Drug

Other names: chirocaine

Levobupivacaine 0.5%

Drug

Other names: chirocaine

Primary outcomes

  1. postoperative pain scores

    Time frame: 24 hours

    VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,

Secondary outcomes

  1. postoperative total analgesic consumption

    Time frame: Postoperatively 24 h

Other outcomes

  1. side effects

    Time frame: postoperatively 24 h

    In hours of postoperative 1, 2, 4, 8, 12, 16 and 24 nausea, and vomiting will be recorded.Nausea (0=non-existent, 1=mild, 2 = severe) and vomiting (0=non-existent, 1=mild, 2 = severe) of the patients will be scored postoperatively on a 3-point scale.

Sponsors and collaborators

Lead sponsor

Duzce University

Other

Registry information

Official study title

Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 10, 2014
Registry last updated
Jul 22, 2020

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.