Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Phase 4

Terminated

• Conditions: Hemorrhoid
• Interventions: Drug: Normal Saline; Drug: Bupivacaine HCl with Epinephrine; Drug: Exparel

• Registration Number: NCT02104414
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-28
• Study Start: 2014-04
• Study First Submitted QC: 2014-04-01
• Study First Posted: 2014-04-04
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Results First Submitted: 2017-04-17
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-03
• Last Update Submitted: 2018-12-03
• Results First Posted: 2018-12-04
• Last Update Posted: 2018-12-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal Saline	30mL Normal Saline
Bupivacaine HCl with epinephrine	Bupivacaine HCl with Epinephrine	75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Exparel	Exparel	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)

Primary Outcome Measures

Name	Time	Method
Post Operative Pain Control	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

Name	Time	Method
Number of Oxycodone Tablets Taken	up to 4 days	Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Postoperative Opioid Consumption - Hydromorphone I.V	1 hour and 2 hours post op
Number of Participants With Postoperative Nausea and Vomiting	up to 4 days	Number of participants with postoperative nausea and vomiting episodes
Number of Participants With Urinary Retention	up to 4 days
Number of Participants With Pain During Bowel Movements	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

Trial Locations

Locations (1)

St.Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States