Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

St. Luke's-Roosevelt Hospital Center

Status and phase: Terminated; Phase 4

Conditions: Hemorrhoid

Treatments: Drug: Exparel; Drug: Normal Saline; Drug: Bupivacaine HCl with Epinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02104414

13-0062

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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11 participants in 3 patient groups, including a placebo group

Exparel

Active Comparator group

Description:

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

Treatment:

Drug: Exparel

Bupivacaine HCl with epinephrine

Active Comparator group

Description:

75mg/30mL 0.25% Bupivacaine HCl with epinephrine

Treatment:

Drug: Bupivacaine HCl with Epinephrine

Normal Saline

Placebo Comparator group

Description:

30mL Normal Saline

Treatment:

Drug: Normal Saline