ClinicalTrials.gg
CompletedNCT07924254Updated Nov 9, 2026

Comparison of Postoperative Pain, Nausea, and Vomiting Between Veress Needle and Direct Trocar Entry in Laparoscopic Cholecystectomy

An interventional study of Veress Needle Entry in Cholelithiasis, Postoperative Pain and Postoperative Nausea and Vomiting, sponsored by Islamabad Medical and Dental College. Completed at 1 site in Pakistan. Open to participants aged Up to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Islamabad Medical and Dental College · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 10 months after the study started (first participant enrolled Jan 2025, registered Nov 2026).
Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Not applicable
Ages
Up to 60 Years
Sex
All
01

Study summary

This study will compare pain, nausea, and vomiting after keyhole gallbladder removal in adults with symptomatic gallstones.

The study will examine two commonly used methods for entering the abdomen. In the Veress needle method, a thin needle is used to introduce carbon dioxide gas before the first surgical port is inserted. In the direct trocar method, the first surgical port is inserted before the gas is introduced.

Adults aged 18-60 years undergoing planned keyhole gallbladder surgery at Akbar Niazi Teaching Hospital, Islamabad, Pakistan, will be invited to participate. The operating surgeon will choose the entry method according to routine clinical practice and the patient's clinical needs. The research team will record the method used without assigning treatment.

Pain will be assessed at 2, 6, and 24 hours after surgery using a scale from 0, meaning no pain, to 10, meaning the worst imaginable pain. Nausea and vomiting will be recorded during the first 24 hours. Additional pain relief and medicines used to treat nausea or vomiting will also be documented.

The findings may help clinicians understand whether postoperative symptoms differ between these two entry methods.

Read the detailed description

his single-centre, prospective comparative observational study will examine postoperative symptoms following Veress needle entry and direct trocar entry in adults undergoing elective laparoscopic cholecystectomy for symptomatic cholelithiasis.

Eligible patients will be recruited consecutively after informed consent. The abdominal entry technique will be selected by the operating surgeon according to routine practice and clinical judgment, independently of research participation. Participants will be classified into two cohorts according to the technique received.

The clinical protocol specifies standardized general anesthesia, postoperative analgesia, and prophylaxis against postoperative nausea and vomiting. Rescue analgesics and additional antiemetic treatment will be administered when clinically indicated and documented.

Baseline and perioperative information will be collected using a structured data collection form. Postoperative pain will be measured using a visual analogue scale at 2, 6, and 24 hours after surgery. The occurrence of nausea and vomiting will be recorded throughout the first 24 postoperative hours. Additional analgesic and antiemetic requirements will also be documented.

02

Conditions studied

  • Cholelithiasis
  • Postoperative Pain
  • Postoperative Nausea and Vomiting

Keywords

  • Laparoscopic cholecystectomy
  • Veress needle
  • Direct Trocar entry
  • Laparoscopic entry
  • Postoperative pain
  • postoperative nausea
  • postoperative vomiting
03

In context

Cholelithiasis

189 studies on the registry are indexed under Cholelithiasis; 42 are open to participants now.

This study's enrollment of 86 is close to the median of 90 across 135 interventional studies indexed under Cholelithiasis.

Browse Cholelithiasis studies →

Lead sponsor

Islamabad Medical and Dental College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

nclusion Criteria:

  • Adults aged 18-60 years.
  • Male or female patients with symptomatic cholelithiasis.
  • Scheduled for elective laparoscopic cholecystectomy.
  • Willing and able to provide .

Exclusion Criteria:

  • Complicated gallstone disease.
  • Previous upper abdominal surgery.
  • Known allergy to anesthetic agents or antiemetic medications specified in the clinical protocol.
  • physical status class IV or higher.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Veress Needle Entry

    Patients undergoing elective laparoscopic cholecystectomy using Veress needle entry. A Veress needle is used to establish carbon dioxide pneumoperitoneum before insertion of the primary trocar. The operating surgeon selects the technique according to routine clinical practice and clinical judgment, independently of study participation.

    Procedure: Veress Needle Entry

Interventions

  • ProcedureVeress Needle Entry

    Establishment of carbon dioxide pneumoperitoneum using a Veress needle before insertion of the primary trocar for laparoscopic cholecystectomy.

06

What researchers measure

Primary outcomes

  1. Postoperative pain score

    Pain measured using a visual analogue scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain.

    Time frame: at 2, 6 and 24 hours after surgery

Secondary outcomes

  1. Participants requiring rescue analgesia: within 24 hours after surgery.

    Adults aged 18-60 years. Male or female patients with symptomatic cholelithiasis. Scheduled for elective laparoscopic cholecystectomy. Willing and able to provide informed consent.

    Time frame: 3 months

07

Study locations

1 site
  • IMDC
    Islamabad, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924254
Lead sponsor
Islamabad Medical and Dental College
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Jan 1, 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2026
Last update
Nov 9, 2026

Study contacts

Asma Irfan, MBBS PhD
study chair · Islamabad Medical & Dental college

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion