An interventional study of Port-site local anesthesia infiltration and Port-Site Saline Infiltration (Placebo) in Appendectomy, Laparoscopic, Appendicitis Acute and Pain Management, sponsored by YUNUS YÜKSEL. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by YUNUS YÜKSEL · Not applicable, Interventional, and Treatment
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."
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."
419 studies on the registry are indexed under Appendicitis; 67 are open to participants now.
This study's planned enrollment of 300 is above the median of 111 across 252 interventional studies indexed under Appendicitis.
Browse Appendicitis studies →This is the only study on the registry with YUNUS YÜKSEL as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Specimen is extracted from the left lower quadrant port. Local anesthesia infiltration is applied to all port sites.
Drug: Port-site local anesthesia infiltration
Specimen is extracted from the periumblical port. Local anesthesia infiltration is applied to all port sites.
Drug: Port-site local anesthesia infiltration
Specimen is extracted from the left lower quadrant port. No local anesthesia is infiltrated to the port sites
Other: Port-Site Saline Infiltration (Placebo)
Specimen is extracted from the periumblical port. No local anesthesia is infiltrated to the port sites
Other: Port-Site Saline Infiltration (Placebo)
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
Postoperative Pain Score at the Specimen Extraction Site
Evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).
Time frame: Postoperative 8th hour.
Postoperative Pain Scores at Subsequent Time Points
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 2th, 4th, 12th, and 24th hours.
Total Postoperative Analgesic Consumption
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: Postoperative 24 hours
Length of Hospital Stay
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 postoperative admission to the general surgery ward until hospital discharge.
Operative Duration
The total surgical duration, measured in minutes from the initial skin incision to final wound closure.
Time frame: From initial skin incision to final wound closure (intraoperatively).
Total Intraoperative Insufflation Gas Volume
The total volume of carbon dioxide gas used for pneumoperitoneum throughout the surgical procedure, recorded in liters from the insufflator device.
Time frame: From initiation of pneumoperitoneum until completion of the surgical procedure.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Dec 2026, 7 months after the start.
Of 89 non-industry interventional studies with no phase under Appendicitis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 7 months is below that.
Counting every sponsor, half of 91 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
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