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

September 11, 2026 updated by: YUNUS YÜKSEL
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."

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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."

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Kayapınar
      • Diyarbakır, Kayapınar, Turkey (Türkiye), 21070
        • Recruiting
        • Gazi Yasargil Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Left Lower Quadrant Extraction - Local Anesthesia
Specimen is extracted from the left lower quadrant port. Local anesthesia infiltration is applied to all port sites.
Drug: Port-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
Experimental: Periumbilical Extraction - Local Anesthesia
Specimen is extracted from the periumblical port. Local anesthesia infiltration is applied to all port sites.
Drug: Port-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
Active Comparator: Left Lower Quadrant Extraction - No Local Anesthesia
Specimen is extracted from the left lower quadrant port. No local anesthesia is infiltrated to the port sites
Other: Port-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
Active Comparator: Periumbilical Extraction - No Local Anesthesia
Specimen is extracted from the periumblical port. No local anesthesia is infiltrated to the port sites
Other: Port-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Score at the Specimen Extraction Site
Time Frame: Postoperative 8th hour.
Evaluated using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst possible pain).
Postoperative 8th hour.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Scores at Subsequent Time Points
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)
Postoperative 2th, 4th, 12th, and 24th hours.
Total Postoperative Analgesic Consumption
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.
Postoperative 24 hours
Length of Hospital Stay
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.
From postoperative admission to the general surgery ward until hospital discharge.
Operative Duration
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.
From initial skin incision to final wound closure (intraoperatively).
Total Intraoperative Insufflation Gas Volume
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.
From initiation of pneumoperitoneum until completion of the surgical procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YUNUS YÜKSEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 17, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170 (Merck)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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