Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

Hemorrhoid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02104414
• Other study ID #: 13-0062
• Status: Terminated
• Phase: Phase 4
• Start date: April 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2018
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhoid
• Hemorrhoids

Intervention

Drug:
• Exparel
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
• Normal Saline
30mL Normal Saline

Locations

Country	Name	City	State
United States	St.Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Oxycodone Tablets Taken	Number of postoperative opioid consumption - oxycodone tablets (5mg each)	up to 4 days
Secondary	Postoperative Opioid Consumption - Hydromorphone I.V		1 hour and 2 hours post op
Secondary	Number of Participants With Postoperative Nausea and Vomiting	Number of participants with postoperative nausea and vomiting episodes	up to 4 days
Secondary	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
Secondary	Number of Participants With Urinary Retention		up to 4 days