Postoperative Pain
Conditions
Keywords
Gynecologic surgery, Pain management, TAP Block, Regional Anesthesia, Intravenous Analgesia, ERAS
Brief summary
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.
Detailed description
This prospective, randomized controlled trial included patients undergoing laparoscopic gynecologic procedures (e.g., myomectomy, ovarian cystectomy, endometriosis surgery). Patients were randomized into two groups: * 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 Group: 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. Primary outcome: Postoperative pain intensity (NRS) at 1, 6, and 24 hours. Secondary outcomes included additional analgesic use, side effects, and patient satisfaction.
Interventions
DRUGTAP 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).
Sponsors
University of Foggia
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* age \> 18 years, scheduled for elective gynecological surgery
Exclusion criteria
* age \<18, emergency surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity (Numeric Rating Scale) | 1, 6, 24 hours postoperatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Analgesic Consuption. | 0-24 hours postoperatively. | Total dose of tramadol (in Milligrams) administered in the first 24 hours after surgery will be recorded and compared between groups. |
| Incidence of Side Effects. | 0-24 hours postoperatively | Occurrence of side effects such nausea, vomiting and sedation will be recorded and expressed as a percentage of patients (%) affected in each group. |
| Patient Satisfaction With Analgesia | 24 hours postoperatively | 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. |
Countries
Italy
Outcome results
None listed