NCT07824908

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."

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress70%
Apr 2026Dec 2026

Study Start

First participant enrolled

April 24, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

September 17, 2026

Status Verified

June 1, 2026

Enrollment Period

7 months

First QC Date

September 6, 2026

Last Update Submit

September 11, 2026

Conditions

Appendectomy, LaparoscopicAppendicitis AcutePain Management

Keywords

appendicitis acuteappendectomy laparoscopicpain managementextraction site

Outcome Measures

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).

    Postoperative 8th hour.

Secondary Outcomes (5)

  • Postoperative Pain Scores at Subsequent Time Points

    Postoperative 2th, 4th, 12th, and 24th hours.

  • Total Postoperative Analgesic Consumption

    Postoperative 24 hours

  • Length of Hospital Stay

    From postoperative admission to the general surgery ward until hospital discharge.

  • Operative Duration

    From initial skin incision to final wound closure (intraoperatively).

  • Total Intraoperative Insufflation Gas Volume

    From initiation of pneumoperitoneum until completion of the surgical procedure.

Study Arms (4)

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.

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.

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

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

Other: Port-Site Saline Infiltration (Placebo)

Interventions

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

Left Lower Quadrant Extraction - Local AnesthesiaPeriumbilical Extraction - Local Anesthesia
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

Left Lower Quadrant Extraction - No Local AnesthesiaPeriumbilical Extraction - No Local Anesthesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older
  • Diagnosed with acute appendicitis
  • Scheduled for emergency laparoscopic appendectomy
  • Informed consent obtained

You may not qualify if:

  • Conversion to open surgery
  • Known allergy to local anesthetics
  • Cognitive impairment or inability to understand the NRS scoring system
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi Yasargil Training and Research Hospital

Diyarbakır, Kayapınar, 21070, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AppendicitisAgnosia

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsGastroenteritisGastrointestinal DiseasesDigestive System DiseasesCecal DiseasesIntestinal DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
General Surgery Resident

Study Record Dates

First Submitted

September 6, 2026

First Posted

September 17, 2026

Study Start

April 24, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

September 17, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)