Phase 1
Completed N=135
Injection of Local Anesthetic to Trocar Insertion Sites After Laparoscopy
Pain, Postoperative
Source: ClinicalTrials.gov NCT01688596 ↗
Enrolled (actual)
135
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) — 4.1; 3.4 units on a scale
Summary
The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) |
4.1; 3.4 | — |
| PRIMARY Postoperative Pain Score |
3.5; 4.0 | — |
| SECONDARY Estimated Blood Loss > 200 mL |
2; 2 | — |
| SECONDARY Surgical Complications |
0; 0 | — |
| SECONDARY Operating Time |
73.3; 63.8 | — |
| SECONDARY Length of Hospital Stay >= 24 Hours |
36; 30 | — |
| SECONDARY Histopathologic Diagnosis |
26; 21; 10; 12; 5; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patients who are scheduled for a laparoscopic hysterectomy for benign indications at the Department of Obstetrics & Gynecology's Division of Minimally Invasive Surgery at Milton S. Hershey Medical Center will be included.
Exclusion Criteria
- Patients who are scheduled for a hysterectomy through the vaginal or abdominal approach will be excluded. Patients with preoperative indications of endometriosis or chronic pelvic pain will also be excluded since these patients could potentially have higher thresholds of pain.
Data sourced from ClinicalTrials.gov (NCT01688596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.