Gynecologic Laparoscopic SurgeryNCT07030647
"Efficacy of Local Anesthetic for Postoperative Pain in Gynecologic Laparoscopy"
A study testing Bupivacaine 0.25% in people with Gynecologic Laparoscopic Surgery and Postoperative Pain, run by Usama Ahmed Elsaeed Salem, MD at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gynecologic Laparoscopic Surgery, Postoperative Pain, Recovery Outcomes
- What is being tested?
- Bupivacaine 0.25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Known allergy or hypersensitivity to local anesthetics (e.g., lidocaine or bupivacaine)
- Body Mass Index (BMI) ≥ 35 kg/m²
- Severe hepatic or renal impairment
- Chronic pain conditions requiring regular opioid use
- History of major abdominal surgery
- Refusal to provide informed consent or to enroll in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, 11562
About this study
Official title: Efficacy of the Analgesic Effect of Local Anesthetic Injection on Postoperative Pain in Gynecological Laparoscopic Surgeries: A Randomized Controlled Trial
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.
- Being tested
- Bupivacaine 0.25%
- Keywords
- Gynecological laparoscopy, local anesthetic infiltration, postoperative pain, recovery, bupivacaine, port-site infiltration, Intraperitoneal local anesthetic
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
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.
Bupivacaine 0.25%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Port Site Local Anesthetic Injection (Group A) | Experimental | Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery. Receives: Drug: Bupivacaine 0.25% |
| Intraperitoneal Local Anesthetic Injection (Group B) | Experimental | Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments. Receives: Drug: Bupivacaine 0.25% |
| Control (Group C) | No intervention | Participants receive no local anesthetic injection during surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Time to First Analgesic Request
Measured: 24 hours after surgery
Secondary outcomes (4)
Total Analgesic Consumption
Measured: within 24 hours after surgery
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.
Measured: 24 hours postoperatively
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.
Measured: From end of surgery until hospital discharge assessed up to 7 days
Time to First Patient Ambulation
Measured: Within 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Mar 2024
- Primary completion5 Feb 2025
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Laparoscopic SurgeryStudies 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, Care provider
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Usama Ahmed Elsaeed Salem, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Usama Ahmed Elsaeed Salem, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030647
- Sponsor's protocol ID
- MS-447-2024
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Elsaeed UA, Algyoushy EAFIH, Hatem DLM. Effect of port-site and intraperitoneal local anesthetic injection versus placebo on postoperative pain and recovery after gynecologic laparoscopic surgery: a randomized controlled trial. Sci Rep. 2025 Sep 12;15(1):32466. doi: 10.1038/s41598-025-18389-w.
PubMed 40940430
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Analgesic Effect of Local Anesthetic Injection on Postoperative Pain in Gynecological Laparoscopic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07030647
- Acronym / sponsor ID
- MS-447-2024
- Keywords
- Gynecological laparoscopy, local anesthetic infiltration, postoperative pain, recovery, bupivacaine, port-site infiltration, Intraperitoneal local anesthetic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Usama Ahmed Elsaeed Salem, MDUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 22 Jun 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Port Site Local Anesthetic Injection (Group A) | Experimental | Drug: Bupivacaine 0.25%Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery. |
| Intraperitoneal Local Anesthetic Injection (Group B) | Experimental | Drug: Bupivacaine 0.25%Participants receive an intraperitoneal local anesthetic injection before removal of the laparoscopic instruments. |
| Control (Group C) | No intervention | –Participants receive no local anesthetic injection during surgery. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female participants aged 18 to 60 years
- 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.
Key exclusion criteria (6 listed)
- Known allergy or hypersensitivity to local anesthetics (e.g., lidocaine or bupivacaine)
- Body Mass Index (BMI) ≥ 35 kg/m²
- Severe hepatic or renal impairment
- Chronic pain conditions requiring regular opioid use
- History of major abdominal surgery
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 |
|---|---|---|
| Bupivacaine 0.25%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. | Drug | Intraperitoneal Local Anesthetic Injection (Group B) |
| Bupivacaine 0.25%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. | Drug | Port Site Local Anesthetic Injection (Group A) |
Primary outcome
Postoperative Pain score assessed using the Visual Analog Scale .
Time frame: 24 hours after surgery
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 to First Analgesic Request
Time frame: 24 hours after surgery
4 secondary outcomes
Total Analgesic Consumption
Time frame: within 24 hours after surgery
Patient Satisfaction Score
Time frame: 24 hours postoperatively
Length of Hospital Stay
Time frame: From end of surgery until hospital discharge assessed up to 7 days
Time to First Patient Ambulation
Time frame: Within 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
- Derived from this study: PubMed 40940430Elsaeed UA, Algyoushy EAFIH, Hatem DLM. Effect of port-site and intraperitoneal local anesthetic injection versus placebo on postoperative pain and recovery after gynecologic laparoscopic surgery: a randomized controlled trial. Sci Rep. 2025 Sep 12;15(1):32466. doi: 10.1038/s41598-025-18389-w.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine 0.25% in people with Gynecologic Laparoscopic Surgery and Postoperative Pain, run by Usama Ahmed Elsaeed Salem, MD at 1 site in Egypt.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jun 2025. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain score assessed using the Visual Analog Scale . (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030647, which also lists 1 linked publication.
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 22 Jun 2025.