Postoperative Pain Clinical Trial
Official title:
Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial
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.
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.
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