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

NCT01534416 | Completed Results

• 2 other identifiers: GCO 11-0021HS# 11-00013
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Paracervical Block; Laparoscopic Gynecologic Surgery

Keywords

Paracervical Block; Laparoscopic Surgery; Postoperative Pain; Bupivacaine; Hysterectomy; Myomectomy; Randomized Trial

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Hospital Admission for Postoperative Pain Control

  Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management

  Four hours after conclusion of surgery

Secondary Outcomes (3)

• Postoperative Pain Score

  1and 2 hour postoperatively

• Postoperative Pain Score

  1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative

• Postoperative Day Pain Medication Use

  Postoperative days 0-10

Study Arms (2)

Bupivacaine

EXPERIMENTAL

Subjects receive paracervical block with bupivacaine-epinephrine

Drug: Bupivacaine

Saline

PLACEBO COMPARATOR

Subjects receive paracervical injection of normal saline

Drug: Normal Saline

Interventions

Bupivacaine DRUG

Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.

Also known as: Marcaine

Bupivacaine

Normal Saline DRUG

Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.

Also known as: Saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Male
• Women under 18 years old
• Pregnancy
• Suspected or known malignant disease
• Immunocompromised

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 2008 Oct 2.

  PMID: 18830553 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Rachel L. Barr Grzesh
• Organization: Icahn School of Medicine at Mount Sinai

rachel.barr@mssm.edu

212-241-2995

Study Officials

• Charles Ascher-Walsh, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2012
• First Posted: February 16, 2012
• Study Start: September 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Locations

US (1)