Gazi Yasargil Training and Research Hospital
Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07824908
The aim of this prospective, randomized study is to evaluate the effects of two different specimen extraction sites (periumbilical versus left lower quadrant) and the routine application of port-site local anesthesia infiltration on postoperative pain and complications in patients undergoing laparoscopic appendectomy for acute appendicitis."
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All sexes
Interventional
Not applicable
Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)
Location status: Recruiting
The purpose of this prospective, randomized clinical trial is to investigate the clinical impact of two different specimen extraction sites (periumbilical versus left lower quadrant) on postoperative pain. Additionally, the study evaluates the efficacy of routine preemptive local anesthesia infiltration at all trocar sites. Patients undergoing laparoscopic appendectomy are randomly allocated into four parallel groups based on the extraction site and the administration of local anesthesia. The primary objective is to compare local and regional pain scores at the extraction and non-extraction port sites, assessed via the Numeric Rating Scale (NRS) at the 2nd, 4th, 8th, 12th, and 24th postoperative hours. Secondary outcomes include total postoperative analgesic consumption, operative duration, length of hospital stay."
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Infiltration of local anesthetic solution (bupivacaine) into the skin, subcutaneous tissue, and fascial layers of all trocar sites prior to closure
Prior to wound closure, a total of 10 cc of %0.9 normal saline solution is infiltrated into the skin, subcutaneous tissues, and fascial layers of all trocar sites as a placebo control
Time frame: Postoperative 8th hour.
Evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Postoperative 2th, 4th, 12th, and 24th hours.
Postoperative regional pain assessed at the specimen extraction site and non-extraction port sites using the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst possible pain)
Time frame: Postoperative 24 hours
The total amount of rescue analgesic medication (specifically the cumulative dose of tramadol/contramal required by the patient) administered during the first 24 hours after surgery.
Time frame: From postoperative admission to the general surgery ward until hospital discharge.
The total duration of the patient's hospitalization, measured from the time of admission to the general surgery ward post-surgery until the time of official hospital discharge.
Time frame: From initial skin incision to final wound closure (intraoperatively).
The total surgical duration, measured in minutes from the initial skin incision to final wound closure.
Time frame: From initiation of pneumoperitoneum until completion of the surgical procedure.
The total volume of carbon dioxide gas used for pneumoperitoneum throughout the surgical procedure, recorded in liters from the insufflator device.
YUNUS YÜKSEL
Other
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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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