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Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Information source: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hemorrhoid

Intervention: Exparel (Drug); Bupivacaine HCl with Epinephrine (Drug); Normal Saline (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: St. Luke's-Roosevelt Hospital Center

Official(s) and/or principal investigator(s):
Ali Shariat, MD, Principal Investigator, Affiliation: St. Luke's-Roosevelt Hospital Center

Overall contact:
Ali Shariat, MD, Phone: 914-409-5023, Email: alishariatmd@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Primary outcome: Post operative pain control

Secondary outcome:

Postoperative opioid consumption

Postoperative nausea and vomiting

Frequency of and pain during postoperative bowel movements

Incidence of urinary retention

Eligibility

Minimum age: 21 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Ali Shariat, MD, Phone: 914-409-5023, Email: alishariatmd@gmail.com

St.Luke's-Roosevelt Hospital Center, New York, New York, United States; Recruiting
Ali Shariat, MD, Phone: 914-409-5023, Email: alishariatmd@gmail.com
Ali Shariat, MD, Principal Investigator
Admir Hadzic, MD, PhD, Sub-Investigator
Nipa Gandhi, MD, Sub-Investigator
Additional Information

Starting date: April 2014
Last updated: April 17, 2015

Page last updated: August 23, 2015

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