Back to resultsEfficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Primary Purpose
Hemorrhoid
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Bupivacaine HCl with Epinephrine
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhoid focused on measuring Liposomal Bupivacaine, Exparel
Eligibility Criteria
Inclusion Criteria:
- patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30
Exclusion Criteria:
- contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Sites / Locations
- St.Luke's-Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Exparel
Bupivacaine HCl with epinephrine
Normal Saline
Arm Description
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
30mL Normal Saline
Outcomes
Primary Outcome Measures
Post Operative Pain Control
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Secondary Outcome Measures
Number of Oxycodone Tablets Taken
Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Postoperative Opioid Consumption - Hydromorphone I.V
Number of Participants With Postoperative Nausea and Vomiting
Number of participants with postoperative nausea and vomiting episodes
Number of Participants With Pain During Bowel Movements
Number of participants with pain during postoperative bowel movements
Number of Participants With Urinary Retention
Full Information
NCT ID
NCT02104414
First Posted
March 28, 2014
Last Updated
December 3, 2018
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT02104414
Brief Title
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
Official Title
Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
low enrollment
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the quality and duration of pain relief after a hemorrhoidectomy, provided by locally administered liposomal bupivacaine versus bupivacaine hcl or control with saline. It is hypothesized that liposomal bupivacaine will provide more effective postoperative pain relief than both bupivacaine hcl and the control.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhoid
Keywords
Liposomal Bupivacaine, Exparel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exparel
Arm Type
Active Comparator
Arm Description
266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
Arm Title
Bupivacaine HCl with epinephrine
Arm Type
Active Comparator
Arm Description
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
30mL Normal Saline
Intervention Type
Drug
Intervention Name(s)
Exparel
Other Intervention Name(s)
Liposomal Bupivacaine
Intervention Description
266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine HCl with Epinephrine
Intervention Description
75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Intervention Type
Drug
Intervention Name(s)
Normal Saline
Intervention Description
30mL Normal Saline
Primary Outcome Measure Information:
Title
Post Operative Pain Control
Description
The primary objective is to evaluate analgesia following local infiltration of 30 mL Exparel or the same volume of 0.25% bupivacaine HCl with epinephrine or normal saline. The intensity of pain will be measured using a numerical rating scale (NRS-11) in which 0 represents no pain, and 10 represents extreme pain.
Time Frame
up to 4 days
Secondary Outcome Measure Information:
Title
Number of Oxycodone Tablets Taken
Description
Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Time Frame
up to 4 days
Title
Postoperative Opioid Consumption - Hydromorphone I.V
Time Frame
1 hour and 2 hours post op
Title
Number of Participants With Postoperative Nausea and Vomiting
Description
Number of participants with postoperative nausea and vomiting episodes
Time Frame
up to 4 days
Title
Number of Participants With Pain During Bowel Movements
Description
Number of participants with pain during postoperative bowel movements
Time Frame
Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
Title
Number of Participants With Urinary Retention
Time Frame
up to 4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing hemorrhoidectomy for grade 3 or 4 hemorrhoids who are English-speaking patients, 21-65 yr of age, ASA physical status I-III, BMI<30
Exclusion Criteria:
contraindications to administration of local anesthesia (e.g., local anesthetic allergy), difficult airway (Mallampati>2), psychiatric or cognitive disorders, pregnancy , and history of substance abuse or chronic opioid use
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Shariat, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
St.Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy
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