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Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

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ClinicalTrials.gov Identifier: NCT02104414
Recruitment Status : Terminated (low enrollment)
First Posted : April 4, 2014
Results First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment Phase
Hemorrhoid Drug: Exparel Drug: Bupivacaine HCl with Epinephrine Drug: Normal Saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : April 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016


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 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




Primary Outcome Measures :
  1. Post Operative Pain Control [ Time Frame: up to 4 days ]
    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 :
  1. Number of Oxycodone Tablets Taken [ Time Frame: up to 4 days ]
    Number of postoperative opioid consumption - oxycodone tablets (5mg each)

  2. Postoperative Opioid Consumption - Hydromorphone I.V [ Time Frame: 1 hour and 2 hours post op ]
  3. Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: up to 4 days ]
    Number of participants with postoperative nausea and vomiting episodes

  4. Number of Participants With Pain During Bowel Movements [ Time Frame: Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days ]
    Number of participants with pain during postoperative bowel movements

  5. Number of Participants With Urinary Retention [ Time Frame: up to 4 days ]


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104414


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

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Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT02104414     History of Changes
Other Study ID Numbers: 13-0062
First Posted: April 4, 2014    Key Record Dates
Results First Posted: December 4, 2018
Last Update Posted: December 4, 2018
Last Verified: December 2018
Keywords provided by St. Luke's-Roosevelt Hospital Center:
Liposomal Bupivacaine
Exparel
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Epinephrine
Racepinephrine
Bupivacaine
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