Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Postoperative Pain Paracervical Block Laparoscopic Gynecologic Surgery |
Drug: Bupivacaine with epinephrine Drug: Normal Saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Use of Paracervical Block in Laparoscopic Gynecologic Surgery: A Randomized Controlled Trial |
- Hospital admission for postoperative pain control [ Time Frame: Four hours after conclusion of surgery ] [ Designated as safety issue: No ]
- Postoperative pain score [ Time Frame: 1 hour postoperatively ] [ Designated as safety issue: No ]Postoperative pain levels will be 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 will be assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects will self-report their pain level.
- Postoperative pain score [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: No ]Postoperative pain levels will be 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 will be assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects will self-report their pain level.
- Postoperative pain score [ Time Frame: 4 hours postoperatively ] [ Designated as safety issue: No ]Postoperative pain levels will be 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 will be assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects will self-report their pain level.
- Postoperative pain score [ Time Frame: 1 day postoperatively ] [ Designated as safety issue: No ]Postoperative pain levels will be 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 will be assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects will self-report their pain level.
- Postoperative pain score [ Time Frame: 2 days postoperatively ] [ Designated as safety issue: No ]Postoperative pain levels will be 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 will be assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects will self-report their pain level.
- Postoperative pain medication use [ Time Frame: Postoperative days 0-14 ] [ Designated as safety issue: No ]Type and amount of pain medication by each subject will be recorded in the PACU postoperatively. The subjects then record at home the type and amount of pain medication they use for 14 days postoperatively.
| Estimated Enrollment: | 230 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Bupivacaine
Subjects receive paracervical block with bupivacaine-epinephrine
|
Drug: Bupivacaine with 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
|
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) 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Rachel Barr, MD | 212-241-2827 | rachel.barr@mssm.edu |
| United States, New York | |
| Mount Sinai School of Medicine | Recruiting |
| New York, New York, United States, 10029 | |
| Contact: Rachel Barr, MD 212-241-2827 rachel.barr@mssm.edu | |
| Principal Investigator: Charles Ascher-Walsh, MD | |
| Principal Investigator: | Charles Ascher-Walsh, MD | Mount Sinai School of Medicine |
More Information
No publications provided
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01534416 History of Changes |
| Other Study ID Numbers: | GCO 11-0021, HS# 11-00013 |
| Study First Received: | February 13, 2012 |
| Last Updated: | October 15, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Mount Sinai School of Medicine:
|
Paracervical Block Laparoscopic Surgery Postoperative Pain Bupivacaine |
Hysterectomy Myomectomy Randomized Trial |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Epinephrine Epinephryl borate Bupivacaine Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs |
Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Mydriatics Adrenergic alpha-Agonists Sympathomimetics Vasoconstrictor Agents Cardiovascular Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents |
ClinicalTrials.gov processed this record on May 23, 2013