ClinicalTrials.gg
CompletedNCT07030647Updated Jun 22, 2025

"Efficacy of Local Anesthetic for Postoperative Pain in Gynecologic Laparoscopy"

An interventional study of Bupivacaine 0.25% and Bupivacaine 0.25% in Gynecologic Laparoscopic Surgery, Postoperative Pain and Recovery Outcomes, sponsored by Usama Ahmed Elsaeed Salem, MD. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-06-22.

Sponsored by Usama Ahmed Elsaeed Salem, MD · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Mar 2024, registered Jun 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 362 studies testing bupivacaine in Pain, Postoperative — 55 open to participants now, 58 under way, 5 of them phase 3. Bupivacaine · Pain, Postoperative.

Enrollment
125th of 362
90 · median 70
Started
2024
with 30 others
No phase
109 of 362
24 open now
Registered
318th of 362
by date

Among the 362 studies testing bupivacaine in Pain, Postoperative, this one is the 125th largest by enrollment, is one of 31 that started in 2024, is one of 109 with no phase, and was the 318th registered.

By phase

362 studies; the count open now beside each. This study's row is marked.

Phase 4133 · 18 open
No phasethis study109 · 24 open
Phase 243 · 4 open
Phase 342 · 2 open
Phase 121 · 4 open
Phase 2/311 · 3 open
Phase 1/23 · 0 open

By the year they started

First in 2004; this study’s year is marked. 31 started in 2024.

Size and results

Median enrollment 70 across the 362 interventional studies. Of the 258 that completed or were terminated, 106 (41%) have results posted.

Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 362 studies testing bupivacaine in Pain, Postoperative, or all of them as a file.
02

Study summary

This is a randomized, double-blind, controlled clinical trial evaluating the efficacy of local anesthetic (LA) in reducing postoperative pain in patients undergoing gynecologic laparoscopic surgery. Ninety participants will be randomly assigned into three equal groups: Group A will receive LA injection at the port site, Group B will receive intraperitoneal LA injection, and Group C will serve as the control group with no LA intervention. Postoperative pain will be assessed and compared among the three groups.

03

Conditions studied

  • Gynecologic Laparoscopic Surgery
  • Postoperative Pain
  • Recovery Outcomes
  • Pain Management

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Keywords

  • Gynecological laparoscopy, local anesthetic infiltration, postoperative pain, recovery, bupivacaine, port-site infiltration
  • Intraperitoneal local anesthetic
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Female participants aged 18 to 60 years

Scheduled for elective gynecological laparoscopic procedures, including:

Evaluation for primary or secondary infertility

Assessment of suspected uterine pathology

Evaluation of Müllerian anomalies

Assessment of suspected tubal or peritoneal pathology requiring diagnostic exploration.

Exclusion criteria

Exclusion Criteria:

Known allergy or to local anesthetics (e.g., lidocaine or bupivacaine)

(BMI) ≥ 35 kg/m²

Severe hepatic or renal impairment

Chronic pain conditions requiring regular opioid use

History of major abdominal surgery

Refusal to provide or to enroll in the study

Terms in these criteria, in plain language(3)

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.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
90 participants (actual)

Study arms

  • Experimental
    Port Site Local Anesthetic Injection (Group A)

    Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery.

    Drug: Bupivacaine 0.25%

  • Experimental
    Intraperitoneal Local Anesthetic Injection (Group B)

    Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments.

    Drug: Bupivacaine 0.25%

  • No intervention
    Control (Group C)

    Participants receive no local anesthetic injection during surgery.

Interventions

  • At the end of gynecologic laparoscopic surgery and prior to trocar removal, 40 mL of Bupivacaine 0.25% is instilled intraperitoneal under direct vision to evaluate its analgesic effect.

  • Before trocar insertion in gynecologic laparoscopic surgery, 5 mL of Bupivacaine 0.25% is infiltrated subcutaneously at each trocar port site to assess its effect on postoperative pain.

06

What researchers measure

Primary outcomes

  1. Postoperative Pain score assessed using the Visual Analog Scale .

    Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

    Time frame: 24 hours after surgery

  2. Time to First Analgesic Request

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Total Analgesic Consumption

    Time frame: within 24 hours after surgery

  2. Patient Satisfaction Score

    Patient satisfaction will be measured using a10- point Likert Scale, where 1 = Very Dissatisfied and 10 = Very Satisfied. Higher scores indicate greater satisfaction.

    Time frame: 24 hours postoperatively

  3. Length of Hospital Stay

    The duration (in hours) from the end of surgery to the time of hospital discharge will be recorded. This outcome measures the efficiency of recovery and readiness for discharge.

    Time frame: From end of surgery until hospital discharge assessed up to 7 days

  4. Time to First Patient Ambulation

    Time frame: Within 24 hours after surgery

07

Study locations

1 site
  • Faculty of Medicine, Cairo University
    Cairo, Cairo Governorate 11562, Egypt
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: 12 Months after publication of study results for a year.

Access criteria: Data will be shared upon reasonable request by contacting the corresponding author. Researchers must sign a data use agreement to access the data.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07030647
Lead sponsor
Usama Ahmed Elsaeed Salem, MD
Responsible party
Usama Ahmed Elsaeed Salem, MD (Usama Ahmed Elsaeed Salem, MD, Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Cairo University., Cairo University) — Sponsor-investigator
First posted
Jun 22, 2025
Start date
Mar 1, 2024
Primary completion
Feb 5, 2025
Completion
Mar 30, 2025
Last update
Jun 22, 2025

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 Jun 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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