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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Port Site Local Anesthetic Injection (Group A) | Experimental | Participants receive a local anesthetic injection at the trocar/port sites of laparoscopic gynecologic surgery. |
|
| Intraperitoneal Local Anesthetic Injection (Group B) | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours after surgery |
| Time to First Analgesic Request | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Analgesic Consumption | 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. |
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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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Cairo University | Cairo | Cairo Governorate | 11562 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40940430 | Derived | 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. |
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12 Months after publication of study results for a year.
Data will be shared upon reasonable request by contacting the corresponding author. Researchers must sign a data use agreement to access the data.
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| 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. |
|
| 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. | From end of surgery until hospital discharge assessed up to 7 days |
| Time to First Patient Ambulation | Within 24 hours after surgery |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |