Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy

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.

Study Overview

• Status: Terminated
• Conditions: Hemorrhoid
• Intervention / Treatment: Drug: Exparel; Drug: Bupivacaine HCl with Epinephrine; Drug: Normal Saline

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10027
      • St.Luke's-Roosevelt Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Exparel; 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	Drug: Exparel; 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL); Other Names: Liposomal Bupivacaine
Active Comparator: Bupivacaine HCl with epinephrine; 75mg/30mL 0.25% Bupivacaine HCl with epinephrine	Drug: Bupivacaine HCl with Epinephrine; 75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Placebo Comparator: Normal Saline; 30mL Normal Saline	Drug: Normal Saline; 30mL Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 4 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Oxycodone Tablets Taken	Number of postoperative opioid consumption - oxycodone tablets (5mg each)	up to 4 days
Postoperative Opioid Consumption - Hydromorphone I.V		1 hour and 2 hours post op
Number of Participants With Postoperative Nausea and Vomiting	Number of participants with postoperative nausea and vomiting episodes	up to 4 days
Number of Participants With Pain During Bowel Movements	Number of participants with pain during postoperative bowel movements	Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days
Number of Participants With Urinary Retention		up to 4 days

Collaborators and Investigators

• Sponsor: St. Luke's-Roosevelt Hospital Center
• Investigators: Principal Investigator: Ali Shariat, MD, St. Luke's-Roosevelt Hospital Center

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: March 28, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 3, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Liposomal Bupivacaine; Exparel
• Additional Relevant MeSH Terms: Digestive System Diseases; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhoids; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Anesthetics, Local; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Bupivacaine; Epinephrine
• Other Study ID Numbers: 13-0062