Gynecologic Laparoscopic Surgery, Pain Management, Postoperative Pain, Recovery Outcomes
Conditions
Keywords
Gynecological laparoscopy, local anesthetic infiltration, postoperative pain, recovery, bupivacaine, port-site infiltration, Intraperitoneal local anesthetic
Brief 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.
Interventions
DRUGBupivacaine 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.
Sponsors
Usama Ahmed Elsaeed Salem, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain score assessed using the Visual Analog Scale . | 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 | 24 hours after surgery | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Analgesic Consumption | within 24 hours after surgery | — |
| Patient Satisfaction Score | 24 hours postoperatively | Patient satisfaction will be measured using a10- point Likert Scale, where 1 = Very Dissatisfied and 10 = Very Satisfied. Higher scores indicate greater satisfaction. |
| Length of Hospital Stay | From end of surgery until hospital discharge assessed up to 7 days | 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 to First Patient Ambulation | Within 24 hours after surgery | — |
Countries
Egypt
Outcome results
None listed