Appendectomy, LaparoscopicNCT07824908
Effect Of Specimen Extraction Site And Local Anesthesia On Postoperative Pain In Laparoscopic Appendectomy
A study testing Port-site local anesthesia infiltration in people with Appendectomy, Laparoscopic and Appendicitis Acute, run by YUNUS YÜKSEL at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Appendectomy, Laparoscopic, Appendicitis Acute, Pain Management
- What is being tested?
- Port-site local anesthesia infiltration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Apr 2026to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years or older
- Diagnosed with acute appendicitis
- Scheduled for emergency laparoscopic appendectomy
- Informed consent obtained
Who cannot join
- Conversion to open surgery
- Known allergy to local anesthetics
- Cognitive impairment or inability to understand the NRS scoring system
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi Yasargil Training and Research Hospital
Diyarbakır, Kayapınar, 21070
Yunus YUKSEL, +905334367335, yunusyuksel35@gmail.com
About this study
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."
Read the 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."
- Being tested
- Port-site local anesthesia infiltration, Port-Site Saline Infiltration (Placebo)
- Keywords
- appendicitis acute, appendectomy laparoscopic, pain management, extraction site
- Medical subject headings
- Appendicitis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Port-site local anesthesia infiltrationDrug
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
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
| Study group | Role | What they receive |
|---|---|---|
| Left Lower Quadrant Extraction - Local Anesthesia | Experimental | Specimen is extracted from the left lower quadrant port. Local anesthesia infiltration is applied to all port sites. Receives: Drug: Port-site local anesthesia infiltration |
| Periumbilical Extraction - Local Anesthesia | Experimental | Specimen is extracted from the periumblical port. Local anesthesia infiltration is applied to all port sites. Receives: Drug: Port-site local anesthesia infiltration |
| Left Lower Quadrant Extraction - No Local Anesthesia | Active comparator | Specimen is extracted from the left lower quadrant port. No local anesthesia is infiltrated to the port sites Receives: Other: Port-Site Saline Infiltration (Placebo) |
| Periumbilical Extraction - No Local Anesthesia | Active comparator | Specimen is extracted from the periumblical port. No local anesthesia is infiltrated to the port sites Receives: Other: Port-Site Saline Infiltration (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Postoperative 8th hour.
Secondary outcomes (5)
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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From initiation of pneumoperitoneum until completion of the surgical procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start24 Apr 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Appendectomy, LaparoscopicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YUNUS YÜKSEL
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, YUNUS YÜKSEL, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824908
- Sponsor's protocol ID
- 170
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Specimen Extraction Site And Local Anesthesia On Postoperative Pain In Laparoscopic Appendectomy
- ClinicalTrials.gov ID
- NCT07824908
- Acronym / sponsor ID
- 170
- Keywords
- appendicitis acute, appendectomy laparoscopic, pain management, extraction site
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- YUNUS YÜKSELUniversity, hospital or other
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Left Lower Quadrant Extraction - Local Anesthesia | Experimental | Drug: Port-site local anesthesia infiltrationSpecimen is extracted from the left lower quadrant port. Local anesthesia infiltration is applied to all port sites. |
| Periumbilical Extraction - Local Anesthesia | Experimental | Drug: Port-site local anesthesia infiltrationSpecimen is extracted from the periumblical port. Local anesthesia infiltration is applied to all port sites. |
| Left Lower Quadrant Extraction - No Local Anesthesia | Active comparator | Other: Port-Site Saline Infiltration (Placebo)Specimen is extracted from the left lower quadrant port. No local anesthesia is infiltrated to the port sites |
| Periumbilical Extraction - No Local Anesthesia | Active comparator | Other: Port-Site Saline Infiltration (Placebo)Specimen is extracted from the periumblical port. No local anesthesia is infiltrated to the port sites |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 years or older
- Diagnosed with acute appendicitis
- Scheduled for emergency laparoscopic appendectomy
- Informed consent obtained
Key exclusion criteria (4 listed)
- Conversion to open surgery
- Known allergy to local anesthetics
- Cognitive impairment or inability to understand the NRS scoring system
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Port-site local anesthesia infiltrationInfiltration of local anesthetic solution (bupivacaine) into the skin, subcutaneous tissue, and fascial layers of all trocar sites prior to closure | Drug | Left Lower Quadrant Extraction - Local Anesthesia, Periumbilical Extraction - Local Anesthesia |
| 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 | Other | Left Lower Quadrant Extraction - No Local Anesthesia, Periumbilical Extraction - No Local Anesthesia |
Primary outcome
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).
5 secondary outcomes
Postoperative Pain Scores at Subsequent Time Points
Time frame: Postoperative 2th, 4th, 12th, and 24th hours.
Total Postoperative Analgesic Consumption
Time frame: Postoperative 24 hours
Length of Hospital Stay
Time frame: From postoperative admission to the general surgery ward until hospital discharge.
Operative Duration
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gazi Yasargil Training and Research Hospital
Diyarbakır, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Port-site local anesthesia infiltration in people with Appendectomy, Laparoscopic and Appendicitis Acute, run by YUNUS YÜKSEL at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Score at the Specimen Extraction Site (time frame: Postoperative 8th hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.