Randomized Trial of Wound Infiltration With Extended-release Bupivacaine Before Laparoscopic or Robotic Hysterectomy

• Sponsor: AdventHealth (Other)
• Overall Status: Completed
• CT.gov ID: NCT02352922
• Collaborator: (none)
• Enrollment: 64
• Location: 1
• Arms: 2
• Duration (Months): 7.1
• Patients Per Site Per Month: 9.1

Study Details

Study Description

Brief Summary

The investigators are studying ways to improve pain control after surgery. One way to decrease pain is to inject incisions with a numbing medicine (local anesthetic) while in the operating room. There is an FDA approved extended-release version of a commonly used local anesthetic (bupivacaine) that can last for 4 days instead of 6 hours. The investigators are studying whether using the extended-release medication (Exparel) will give better pain relief after laparoscopic and robotic-assisted hysterectomies.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative; Surgical Procedure, Unspecified	Drug: Liposomal Bupivacaine; Drug: Bupivacaine HCl	Phase 4

Detailed Description

Lidocaine and bupivacaine hydrochloride (HCl) are the most commonly used drugs for wound infiltration during laparoscopic surgery for post-operative pain control. There is some evidence that wound infiltration decreases immediate post-operative pain. While bupivacaine has a slightly slower onset of action (5-10 minutes), it has become the preferred injectable anesthetic for surgical use because of its longer duration of effect (4-8 hours versus 1-2 hours for lidocaine).

DepoFoam bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA) is a newer extended-release formulation of bupivacaine HCl approved by the U.S. Federal Drug Administration in October 2011. In this suspension, bupivacaine is encapsulated in microscopic spherical lipid-based particles of varying size to allow dispersion of the drug over an extended period of time. Analgesia is prolonged up to 96 hours. Given the extended duration of action, this liposomal bupivacaine may be better at providing post-operative pain relief in laparoscopic surgery.

Phase three trials have shown better pain control in the first 24 hours and less opioid use overall in bunionectomies, hemorrhoidectomies, and total knee replacement surgery when compared to placebo. No studies, however, have been published evaluating extended-release liposomal bupivacaine for laparoscopic surgery, or gynecologic surgery in general. Currently, we are using liposomal bupivacaine for pain relief after laparoscopic hysterectomies, but as stated, it has never been formally evaluated.

We hypothesize that liposomal bupivacaine ("extended-release") provides extended pain relief and decreases the need for supplemental opioid use after major laparoscopic surgery. We will be evaluating whether pre-incision infiltration of extended-release bupivacaine decreases post-operative pain from laparoscopic and robotic-assisted hysterectomy compared to bupivacaine HCl ("short-acting"). To achieve this evaluation we designed a double-blinded randomized controlled trial.

Patients who are scheduled to undergo a laparoscopic or robotic-assisted hysterectomy will be invited to participate. Group A will receive pre-incision infiltration of each trocar site with 4 ml of 0.25% Bupivacaine HCl. Group B will receive pre-incision infiltration of each trocar site with 4 ml of extended-release bupivacaine (EXPAREL) (13.3mg/ml). Subjects and outcome assessors will be blinded to group allocation.

Data will be collected while patients are in the hospital on pain levels and consumption of opioid pain medications. Upon discharge, pain levels, functioning, and quantity of opioid and non-steroidal anti-inflammatory (NSAID) pain medications will be collected through online questionnaires. Subjects will be followed until their 2-3 weeks post-operative visit.

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jan 1, 2016
• Actual Study Completion Date: Feb 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Liposomal Bupivacaine extended-release bupivacaine (EXPAREL)	Drug: Liposomal Bupivacaine; pre-incision infiltration with liposomal bupivacaine; Other Names: Exparel
Active Comparator: Bupivacaine HCl short-acting bupivacaine	Drug: Bupivacaine HCl; pre-incision infiltration with bupivacaine HCl; Other Names: Marcaine

Outcome Measures

Primary Outcome Measures

1. Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1). [24 hours]

   Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable

Secondary Outcome Measures

1. NRS Pain Score at 2 Hours [2 hours post-op]

   numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable

2. NRS Pain Score at 4 Hours [4 hours post-op]

   Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable

3. NRS Pain Score at 8 Hours [8 hours post-op]

   Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

4. NRS Pain Score at 16 Hours [16 hours post-op]

   Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

5. NRS Pain Score Post-op Day 2 [2 days post-op]

   Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

6. NRS Pain Score Post-op Day 3 [3 days post-op]

   Pain scale, where 0 = no pain and 10 = worst pain imaginable

7. NRS Pain Score Post-op Day 14 [Post-Operative Day 14]

   Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable

8. Quality of Life as Measured by the Brief Pain Inventory (BPI) [Post-Operative Day 2]

   The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

9. Quality of Life as Measured by the Brief Pain Inventory (BPI) [Post-Operative Day 3]

   The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

10. Quality of Life as Measured by the Brief Pain Inventory (BPI) [Post-Operative Day 14]

    at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes

11. Total Opioid Use Prior to Hospital Discharge [24 hours]

    Oral morphine equivalent of opioid use while in the hospital

12. Total Opioid Use End of Post-op Day 3 [72 hrs post-op]

    Total use of home opioids by pill count/ oral morphine equivalents

13. Total Opioid Use at Post-op Day 14 [Post-Operative Day 14]

    Total use of home opioids by pill count/ oral morphine equivalents

14. Number of Participants With Adverse Events [Post-Operative Day 14]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Benign indication for surgery

2. Planned multiport laparoscopic or robotic assisted hysterectomy

3. Non-pregnant

4. Able to provide informed consent

5. Owns smartphone or computer with internet access

6. Willing to provide contact phone number and accept SMS text messages

7. Ability to speak and read English (because texts and online surveys will be in English only)

Exclusion Criteria:

1. Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)

2. Contraindication to study drug

3. Severe Hepatic disease

4. Severe Kidney disease

5. Current use of monoamine oxidase inhibitors

6. Current use of tricyclic antidepressants

7. History of substance or alcohol abuse within the past 2 years

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Florida Hospital Orlando	Orlando	Florida	United States	32804

Sponsors and Collaborators

• AdventHealth

Investigators

• Principal Investigator: Georgine Lamvu, MD, MPH, Florida Hospital Orlando
• Study Director: Kenneth I Barron, MD, Florida Hospital Orlando

Study Documents (Full-Text)

None provided.

More Information

Publications

• Bergese SD, Onel E, Portillo J. Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. Pain Manag. 2011 Nov;1(6):539-47. doi: 10.2217/pmt.11.62.
• Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
• Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011 Sep;28(9):776-88. doi: 10.1007/s12325-011-0052-y. Epub 2011 Aug 12.
• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.
• Kato J, Ogawa S, Katz J, Nagai H, Kashiwazaki M, Saeki H, Suzuki H. Effects of presurgical local infiltration of bupivacaine in the surgical field on postsurgical wound pain in laparoscopic gynecologic examinations: a possible preemptive analgesic effect. Clin J Pain. 2000 Mar;16(1):12-7.
• Ke RW, Portera SG, Bagous W, Lincoln SR. A randomized, double-blinded trial of preemptive analgesia in laparoscopy. Obstet Gynecol. 1998 Dec;92(6):972-5.
• Loizides S, Gurusamy KS, Nagendran M, Rossi M, Guerrini GP, Davidson BR. Wound infiltration with local anaesthetic agents for laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 12;(3):CD007049. doi: 10.1002/14651858.CD007049.pub2. Review.
• Saleh A, Fox G, Felemban A, Guerra C, Tulandi T. Effects of local bupivacaine instillation on pain after laparoscopy. J Am Assoc Gynecol Laparosc. 2001 May;8(2):203-6.

• Responsible Party: AdventHealth
• ClinicalTrials.gov Identifier: NCT02352922
• Other Study ID Numbers: 691275
• First Posted: Feb 2, 2015
• Last Update Posted: Oct 1, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by AdventHealth: Laparoscopy; Robotic Surgical Procedures; Hysterectomy; Anesthetics, Local; Bupivacaine; Pain, Postoperative
• Additional relevant MeSH terms: Pain, Postoperative; Bupivacaine

Study Results

Participant Flow

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Period Title: Overall Study
STARTED	32	32
COMPLETED	28	28
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl	Total
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl	Total of all reporting groups
Overall Participants	32	32	64
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45 (8.6)	45.4 (9.1)	45.19 (8.86)
Sex: Female, Male (Count of Participants)
Female	32 100%	32 100%	64 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	4 12.5%	8 25%	12 18.8%
White	24 75%	18 56.3%	42 65.6%
More than one race	0 0%	2 6.3%	2 3.1%
Unknown or Not Reported	4 12.5%	4 12.5%	8 12.5%
Region of Enrollment (Count of Participants)
United States	32 100%	32 100%	64 100%
BMI (kg/m^2) [Mean (Full Range) ]
Mean (Full Range) [kg/m^2]	29	27.6	28.3

Outcome Measures

1. Primary Outcome

Title	Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).
Description	Numerical Rating Scale (0-10) post-operative pain score on POD1, where 0 = no pain and 10 = worst pain imaginable
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	30	30
Mean (Standard Deviation) [units on a scale]	4.17 (2.2)	4.97 (2.6)

2. Secondary Outcome

Title	NRS Pain Score at 2 Hours
Description	numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable
Time Frame	2 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	30	31
Mean (Standard Deviation) [units on a scale]	2.53 (2.53)	2.74 (3.24)

3. Secondary Outcome

Title	NRS Pain Score at 4 Hours
Description	Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable
Time Frame	4 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	30	31
Mean (Standard Deviation) [Score on a scale]	3.87 (2.86)	3 (2.95)

4. Secondary Outcome

Title	NRS Pain Score at 8 Hours
Description	Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Time Frame	8 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	30	30
Mean (Standard Deviation) [Score on a scale]	3.77 (2.75)	3.67 (3.01)

5. Secondary Outcome

Title	NRS Pain Score at 16 Hours
Description	Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Time Frame	16 hours post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	29
Mean (Standard Deviation) [score on a scale]	3.1 (3.18)	3.97 (2.76)

6. Secondary Outcome

Title	NRS Pain Score Post-op Day 2
Description	Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Time Frame	2 days post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	3.34 (2.06)	4.17 (2.16)

7. Secondary Outcome

Title	NRS Pain Score Post-op Day 3
Description	Pain scale, where 0 = no pain and 10 = worst pain imaginable
Time Frame	3 days post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	30
Mean (Standard Deviation) [score on a scale]	2.79 (2.26)	4.07 (1.98)

8. Secondary Outcome

Title	NRS Pain Score Post-op Day 14
Description	Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Time Frame	Post-Operative Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	28	28
Mean (Standard Deviation) [score on a scale]	1.64 (2.58)	2.07 (2.58)

9. Secondary Outcome

Title	Quality of Life as Measured by the Brief Pain Inventory (BPI)
Description	The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Time Frame	Post-Operative Day 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	31
Mean (Standard Deviation) [score on a scale]	4.09 (2.58)	4.31 (1.99)

10. Secondary Outcome

Title	Quality of Life as Measured by the Brief Pain Inventory (BPI)
Description	The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Time Frame	Post-Operative Day 3

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	30
Mean (Standard Deviation) [score on a scale]	3.36 (2.71)	3.94 (2.37)

11. Secondary Outcome

Title	Quality of Life as Measured by the Brief Pain Inventory (BPI)
Description	at time of post-op visit The brief pain inventory scale uses the 0 to 10 numerical rating scale to measure pain intensity under four different conditions. On the four conditions 0 = no pain, no relief, and does not interfere, whereas 10 = pain as bad as you can imagine, complete relief, and completely interferes
Time Frame	Post-Operative Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	28	28
Mean (Standard Deviation) [score on a scale]	1.74 (2.61)	1.65 (1.93)

12. Secondary Outcome

Title	Total Opioid Use Prior to Hospital Discharge
Description	Oral morphine equivalent of opioid use while in the hospital
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	32	32
Mean (Full Range) [mg (oral morphine equivalents)]	216	266

13. Secondary Outcome

Title	Total Opioid Use End of Post-op Day 3
Description	Total use of home opioids by pill count/ oral morphine equivalents
Time Frame	72 hrs post-op

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	29	30
Mean (Full Range) [mg (oral morphine equivalents)]	320	344

14. Secondary Outcome

Title	Total Opioid Use at Post-op Day 14
Description	Total use of home opioids by pill count/ oral morphine equivalents
Time Frame	Post-Operative Day 14

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	27	28
Mean (Full Range) [mg (oral morphine equivalents)]	360	443

15. Secondary Outcome

Title	Number of Participants With Adverse Events
Time Frame	Post-Operative Day 14

Outcome Measure Data

Analysis Population Description

if a patient reported a particular adverse effect at more than one time point, the patient was counted only once. Patients may report more than one adverse effect. Analysis and percentages reflect only those with complaints of adverse effects.

Arm/Group Title	Liposomal Bupivacaine	Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine	short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
Measure Participants	16	25
Gas distension/bloated	5 15.6%	9 28.1%
Constipation	5 15.6%	2 6.3%
Nausea	4 12.5%	6 18.8%
Headache	2 6.3%	7 21.9%
Sore throat/cough	1 3.1%	3 9.4%
Dizziness	1 3.1%	3 9.4%

Adverse Events

Arm/Group Title	Liposomal Bupivacaine		Bupivacaine HCl
Arm/Group Description	extended-release bupivacaine (EXPAREL) Liposomal Bupivacaine: pre-incision infiltration with liposomal bupivacaine		short-acting bupivacaine Bupivacaine HCl: pre-incision infiltration with bupivacaine HCl
All Cause Mortality
	Liposomal Bupivacaine		Bupivacaine HCl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Serious Adverse Events
	Liposomal Bupivacaine		Bupivacaine HCl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)
Other (Not Including Serious) Adverse Events
	Liposomal Bupivacaine		Bupivacaine HCl
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/32 (0%)

Limitations/Caveats

study published in JMIG. https://doi.org/10.1016/j.jmig.2016.11.002

More Information

Certain Agreements

Principal Investigators are NOT 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.