Appendectomy, Laparoscopic, Appendicitis Acute, Pain Management
Conditions
Keywords
appendicitis acute, appendectomy laparoscopic, pain management, extraction site
Brief summary
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."
Detailed description
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."
Interventions
DRUGPort-site local anesthesia infiltration
Infiltration of local anesthetic solution (bupivacaine) into the skin, subcutaneous tissue, and fascial layers of all trocar sites prior to closure
OTHERPort-Site Saline Infiltration (Placebo)
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
Sponsors
YUNUS YÜKSEL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 years or older * Diagnosed with acute appendicitis * Scheduled for emergency laparoscopic appendectomy * Informed consent obtained
Exclusion criteria
* Conversion to open surgery * Known allergy to local anesthetics * Cognitive impairment or inability to understand the NRS scoring system * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score at the Specimen Extraction Site | Postoperative 8th hour. | Evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores at Subsequent Time Points | 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) |
| Total Postoperative Analgesic Consumption | 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. |
| Length of Hospital Stay | 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. |
| Operative Duration | 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. |
| Total Intraoperative Insufflation Gas Volume | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed