N/A
N=132
Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
Postoperative Pain · Paracervical Block · Laparoscopic Gynecologic Surgery
Bottom Line
View on ClinicalTrials.gov: NCT01534416 ↗Enrolled (actual)
132
Serious AEs
0.8%
Results posted
Dec 2017
Primary outcome: Primary: Number of Participants With Hospital Admission for Postoperative Pain Control — 23; 17; 10; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bupivacaine (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Hospital Admission for Postoperative Pain Control |
23; 17; 10; 11 | — |
| SECONDARY Postoperative Pain Score |
4.30; 4.69; 3.37; 4.01; 3.83; 4.35 | — |
| SECONDARY Postoperative Pain Score |
4.30; 4.69; 3.37; 4.01; 3.83; 4.35 | — |
| SECONDARY Postoperative Day Pain Medication Use |
52; 52; 17; 10; 43; 39 | — |
Summary
The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.
Eligibility Criteria
Inclusion Criteria
- Female
- Age 18 or older
- Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy
- Surgery being performed for benign disease
Exclusion Criteria
- Male
- Women under 18 years old
- Pregnancy
- Suspected or known malignant disease
- Immunocompromised
Data sourced from ClinicalTrials.gov (NCT01534416). 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.