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Effect Of Specimen Extraction Site And Local Anesthesia On Postoperative Pain In Laparoscopic Appendectomy

ConditionsAppendectomy, LaparoscopicAppendicitis AcutePain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYUNUS YÜKSEL

About this trial

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."

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18 years or older

Diagnosed with acute appendicitis

Scheduled for emergency laparoscopic appendectomy

Informed consent obtained

Disqualifiers

Conversion to open surgery

Known allergy to local anesthetics

Cognitive impairment or inability to understand the NRS scoring system

Pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Port-site local anesthesia infiltration

    Drug

    Infiltration of local anesthetic solution (bupivacaine) into the skin, subcutaneous tissue, and fascial layers of all trocar sites prior to closure

  • Port-Site Saline Infiltration (Placebo)

    Other intervention

    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

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: Left Lower Quadrant Extraction - Local AnesthesiaExperimental treatment 1 intervention
Group B: Periumbilical Extraction - Local AnesthesiaExperimental treatment 1 intervention
Group C: Left Lower Quadrant Extraction - No Local AnesthesiaActive comparator 1 intervention
Group D: Periumbilical Extraction - No Local AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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
3

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.
4

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).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

YUNUS YÜKSEL

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Sponsor institution

Source ClinicalTrials.gov
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