Efficacy of Rectal Infiltration of Exparel for Analgesic Benefit Following Hemorrhoidectomy

• Sponsor: St. Luke's-Roosevelt Hospital Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02104414
• Collaborator: (none)
• Enrollment: 11
• Location: 1
• Arms: 3
• Duration (Months): 21
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemorrhoid	Drug: Exparel; Drug: Bupivacaine HCl with Epinephrine; Drug: Normal Saline	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Comparison of Rectal Infiltration of Exparel vs. 0.25% Bupivacaine With Epinephrine vs. Placebo for Analgesic Benefit Following Hemorrhoidectomy
• Study Start Date: Apr 1, 2014
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Jan 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exparel 266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	Drug: Exparel; 266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL); Other Names: Liposomal Bupivacaine
Active Comparator: Bupivacaine HCl with epinephrine 75mg/30mL 0.25% Bupivacaine HCl with epinephrine	Drug: Bupivacaine HCl with Epinephrine; 75mg/30mL 0.25% Bupivacaine HCl with epinephrine
Placebo Comparator: Normal Saline 30mL Normal Saline	Drug: Normal Saline; 30mL Normal Saline

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of Oxycodone Tablets Taken [up to 4 days]

   Number of postoperative opioid consumption - oxycodone tablets (5mg each)

2. Postoperative Opioid Consumption - Hydromorphone I.V [1 hour and 2 hours post op]

3. Number of Participants With Postoperative Nausea and Vomiting [up to 4 days]

   Number of participants with postoperative nausea and vomiting episodes

4. 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

5. Number of Participants With Urinary Retention [up to 4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St.Luke's-Roosevelt Hospital Center	New York	New York	United States	10027

Sponsors and Collaborators

• St. Luke's-Roosevelt Hospital Center

Investigators

• Principal Investigator: Ali Shariat, MD, St. Luke's-Roosevelt Hospital Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: St. Luke's-Roosevelt Hospital Center
• ClinicalTrials.gov Identifier: NCT02104414
• Other Study ID Numbers: 13-0062
• First Posted: Apr 4, 2014
• Last Update Posted: Dec 4, 2018
• Last Verified: Dec 1, 2018

• Keywords provided by St. Luke's-Roosevelt Hospital Center: Liposomal Bupivacaine; Exparel
• Additional relevant MeSH terms: Hemorrhoids; Epinephrine; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Period Title: Overall Study
STARTED	5	4	2
COMPLETED	5	4	2
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline	Total
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline	Total of all reporting groups
Overall Participants	5	4	2	11
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44.8 (14.61)	40.75 (13.1)	51.5 (9.19)	44.54 (10.36)
Sex: Female, Male (Count of Participants)
Female	1 20%	2 50%	1 50%	4 36.4%
Male	4 80%	2 50%	1 50%	7 63.6%

Outcome Measures

1. Primary Outcome

Title	Post Operative Pain Control
Description	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.
Time Frame	up to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Hour 1	0	1.33	7
Hour 2	0	1.0	2.5
Day 1	5.75	6.5	5.5
Day 2	3	4.5	4
Day 3	2.25	5.0	3
Day 4	2.67	3.0	2

2. Secondary Outcome

Title	Number of Oxycodone Tablets Taken
Description	Number of postoperative opioid consumption - oxycodone tablets (5mg each)
Time Frame	up to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Hour 1	0 (0)	0 (0)	0 (0)
Hour 2	0 (0)	0 (0)	0 (0)
Day 1	2.2 (2.28)	2.67 (1.53)	1.5 (0.71)
Day 2	2 (1.58)	1.67 (0.58)	2.5 (0.71)
Day 3	1.4 (1.52)	1.5 (0.78)	2.5 (0.71)
Day 4	2 (1.63)	1 (0)	1.5 (0.71)

3. Secondary Outcome

Title	Postoperative Opioid Consumption - Hydromorphone I.V
Time Frame	1 hour and 2 hours post op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Hour 1	0.35 (0.47)	0 (0)	0.8 (0.42)
Hour 2	0.5 (0.6)	0 (0)	0.6 (0.28)

4. Secondary Outcome

Title	Number of Participants With Postoperative Nausea and Vomiting
Description	Number of participants with postoperative nausea and vomiting episodes
Time Frame	up to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Hour 1	0 0%	0 0%	0 0%
Hour 2	0 0%	0 0%	0 0%
Day 1	0 0%	0 0%	0 0%
Day 2	0 0%	0 0%	0 0%
Day 3	0 0%	0 0%	0 0%
Day 4	0 0%	0 0%	0 0%

5. Secondary Outcome

Title	Number of Participants With Pain During Bowel Movements
Description	Number of participants with pain during postoperative bowel movements
Time Frame	Hourly from PACU arrival to discharge and Q4H from 10:00-22:00 postoperatively for 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Day 1	1 20%	1 25%	1 50%
Day 2	2 40%	3 75%	1 50%
Day 3	5 100%	4 100%	2 100%
Day 4	5 100%	4 100%	2 100%

6. Secondary Outcome

Title	Number of Participants With Urinary Retention
Time Frame	up to 4 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exparel	Bupivacaine HCl With Epinephrine	Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)	75mg/30mL 0.25% Bupivacaine HCl with epinephrine	30mL Normal Saline
Measure Participants	5	4	2
Day 1	0 0%	0 0%	0 0%
Day 2	0 0%	0 0%	0 0%
Day 3	0 0%	0 0%	0 0%
Day 4	0 0%	0 0%	0 0%

Adverse Events

Adverse Event Reporting Description	There were no adverse events
Arm/Group Title	Exparel		Bupivacaine HCl With Epinephrine		Normal Saline
Arm/Group Description	266mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)		75mg/30mL 0.25% Bupivacaine HCl with epinephrine		30mL Normal Saline
All Cause Mortality
	Exparel		Bupivacaine HCl With Epinephrine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/2 (0%)
Serious Adverse Events
	Exparel		Bupivacaine HCl With Epinephrine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Exparel		Bupivacaine HCl With Epinephrine		Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/4 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.