Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Hemorrhoid

Intervention / Treatment
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* Drug: Exparel
* Drug: Bupivacaine HCl with Epinephrine
* Drug: Normal Saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liposomal Bupivacaine, Exparel