Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Optimal postoperative pain control is crucial in laparoscopic gynecologic surgery, particularly within Enhanced Recovery After Surgery (ERAS) protocols. The transversus abdominis plane (TAP) block is a regional anesthesia technique that may reduce opioid consumption and enhance recovery. However, data comparing TAP block directly with standard intravenous analgesia in this surgical context are limited.
This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups:
Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tap block group | - TAP Block Group: Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron). | ||
| intravenous analgesia | Standard intraoperative intravenous analgesia as above, followed by a postoperative elastomeric pump delivering tramadol 500 mg and ondansetron in 100 ml saline at 2 ml/h for 48 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAP Block Group | Drug | Bilateral ultrasound-guided TAP block with 0.25% levobupivacaine and 75 mcg clonidine per side, plus standard intraoperative intravenous analgesia (ketorolac, tramadol, ondansetron). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity (Numeric Rating Scale) | Postoperative pain will be assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse pain. Pain scores will be recorded at 1, 6, and 24 hours postoperatively. | 1, 6, 24 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Analgesic Consuption. | Total dose of tramadol (in Milligrams) administered in the first 24 hours after surgery will be recorded and compared between groups. | 0-24 hours postoperatively. |
| Incidence of Side Effects. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
all consecutive women undergoing gynecological surgery
patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery).
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico di Foggia | Foggia | Apulia | 71122 | Italy |
Not sure
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Occurrence of side effects such nausea, vomiting and sedation will be recorded and expressed as a percentage of patients (%) affected in each group.
| 0-24 hours postoperatively |
| Patient Satisfaction With Analgesia | Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale (1= very dissatisfied; 5= very satisfied) at 24 hours after surgery. | 24 hours postoperatively |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |