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Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

This study has been terminated.
(low enrollment)
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT02104414
First received: March 28, 2014
Last updated: January 5, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Hemorrhoid
Drug: Exparel
Drug: Bupivacaine HCl with Epinephrine
Drug: Normal Saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Post operative pain control [ Time Frame: The first 96 hours ]
    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:
  • Postoperative opioid consumption [ Time Frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days ]
  • Postoperative nausea and vomiting [ Time Frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days ]
  • Frequency of and pain during postoperative bowel movements [ Time Frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days ]
  • Incidence of urinary retention [ Time Frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days ]

Enrollment: 11
Study Start Date: April 2014
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02104414

Locations
United States, New York
St.Luke's-Roosevelt Hospital Center
New York, New York, United States, 10027
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Ali Shariat, MD St. Luke's-Roosevelt Hospital Center
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT02104414     History of Changes
Other Study ID Numbers: 13-0062
Study First Received: March 28, 2014
Last Updated: January 5, 2017

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Liposomal Bupivacaine
Exparel

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Bupivacaine
Epinephrine
Racepinephrine
Epinephryl borate
Analgesics
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics

ClinicalTrials.gov processed this record on April 28, 2017