Postoperative Pain Clinical Trial
Official title:
Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
Verified date | December 2017 |
Source | Icahn School of Medicine at Mount Sinai |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 132 |
Est. completion date | September 2013 |
Est. primary completion date | September 2013 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Icahn School of Medicine at Mount Sinai |
United States,
Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management | Four hours after conclusion of surgery | |
Secondary | Postoperative Pain Score | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. | 1and 2 hour postoperatively | |
Secondary | Postoperative Pain Score | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level. | 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative | |
Secondary | Postoperative Day Pain Medication Use | Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively. | Postoperative days 0-10 |
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