Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-01-31

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.

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Detailed Description

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Conditions

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Hemorrhoid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Exparel

266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Group Type ACTIVE_COMPARATOR

Exparel

Intervention Type DRUG

266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Bupivacaine HCl with epinephrine

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Group Type ACTIVE_COMPARATOR

Bupivacaine HCl with Epinephrine

Intervention Type DRUG

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Normal Saline

30mL Normal Saline

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

30mL Normal Saline

Interventions

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Exparel

266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Intervention Type DRUG

Bupivacaine HCl with Epinephrine

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Intervention Type DRUG

Normal Saline

30mL Normal Saline

Intervention Type DRUG

Other Intervention Names

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Liposomal Bupivacaine

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

Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes