Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
|ClinicalTrials.gov Identifier: NCT01534416|
Recruitment Status : Completed
First Posted : February 16, 2012
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Pain Paracervical Block Laparoscopic Gynecologic Surgery||Drug: Bupivacaine Drug: Normal Saline||Not Applicable|
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain.
Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5—10).
For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery.
Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Subjects receive paracervical block with bupivacaine-epinephrine
Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
Other Name: Marcaine
Placebo Comparator: Saline
Subjects receive paracervical injection of normal saline
Drug: Normal Saline
Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
Other Name: Saline
- Number of Participants With Hospital Admission for Postoperative Pain Control [ Time Frame: Four hours after conclusion of surgery ]Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
- Postoperative Pain Score [ Time Frame: 1and 2 hour postoperatively ]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.
- Postoperative Pain Score [ Time Frame: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative ]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.
- Postoperative Day Pain Medication Use [ Time Frame: Postoperative days 0-10 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534416
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Charles Ascher-Walsh, MD||Icahn School of Medicine at Mount Sinai|