Effect of Paracervical Block on Post Operative Pain in Laparoscopic Gynecologic Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01534416
First received: February 13, 2012
Last updated: November 8, 2013
Last verified: November 2013
  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
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

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Hospital admission for postoperative pain control [ Time Frame: Four hours after conclusion of surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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.


Enrollment: 230
Study Start Date: September 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bupivacaine
Subjects receive paracervical block with bupivacaine-epinephrine
Drug: Bupivacaine
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
Criteria

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01534416

Locations
United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
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: November 8, 2013
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
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 21, 2014