Ignite Creation Date:
2024-05-06 @ 12:16 AM
Last Modification Date:
2024-10-26 @ 10:47 AM
Study NCT ID:
NCT01534416
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2012-02-13
Brief Title:
Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Use of Paracervical Block in Laparoscopic Gynecologic Surgery A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 205-10
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
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 205-10
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS 11-00013 | None | None | None |