Pain, PostoperativePhase 4NCT02352922

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

A Phase 4 study testing Liposomal Bupivacaine and Bupivacaine HCl in people with Pain, Postoperative and Surgical Procedure, Unspecified, run by AdventHealth at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Pain, Postoperative, Surgical Procedure, Unspecified
What is being tested?: Liposomal Bupivacaine and Bupivacaine HCl
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 64 participants
Where: 1 siteUnited States
Study dates: Jul 2015to Feb 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Benign indication for surgery
Planned multiport laparoscopic or robotic assisted hysterectomy
Non-pregnant
Able to provide informed consent
Owns smartphone or computer with internet access
Willing to provide contact phone number and accept SMS text messages
Ability to speak and read English (because texts and online surveys will be in English only)

Who cannot join

Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)
Contraindication to study drug
Severe Hepatic disease
Severe Kidney disease
Current use of monoamine oxidase inhibitors
Current use of tricyclic antidepressants
History of substance or alcohol abuse within the past 2 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida Hospital Orlando
Orlando, Florida, 32804

Other trials in United States

About this study

Official title: A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy

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.

Read the 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.

Conditions: Pain, Postoperative, Surgical Procedure, Unspecified
Being tested: Liposomal Bupivacaine, Bupivacaine HCl
Keywords: Laparoscopy, Robotic Surgical Procedures, Hysterectomy, Anesthetics, Local, Bupivacaine, Pain, Postoperative
Medical subject headings: Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Liposomal BupivacaineDrug
Also called Exparel
pre-incision infiltration with liposomal bupivacaine
Bupivacaine HClDrug
Also called Marcaine
pre-incision infiltration with bupivacaine HCl

Study groups in NCT02352922
Study group	Role	What they receive
Liposomal Bupivacaine	Experimental	extended-release bupivacaine (EXPAREL) Receives: Drug: Liposomal Bupivacaine
Bupivacaine HCl	Active comparator	short-acting bupivacaine Receives: Drug: Bupivacaine HCl

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (14)

NRS Pain Score at 2 Hours
numeric rating scale (0-10), mean and SD, where 0 = no pain and 10 = worst pain imaginable
Measured: 2 hours post-op
NRS Pain Score at 4 Hours
Pain scale measured from 0-10, where 0 = no pain and 10 = worst pain imaginable
Measured: 4 hours post-op
NRS Pain Score at 8 Hours
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Measured: 8 hours post-op
NRS Pain Score at 16 Hours
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Measured: 16 hours post-op
NRS Pain Score Post-op Day 2
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Measured: 2 days post-op
NRS Pain Score Post-op Day 3
Pain scale, where 0 = no pain and 10 = worst pain imaginable
Measured: 3 days post-op
NRS Pain Score Post-op Day 14
Pain scale (0-10), where 0 = no pain and 10 = worst pain imaginable
Measured: Post-Operative Day 14
Quality of Life as Measured by the Brief Pain Inventory (BPI)
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
Measured: Post-Operative Day 2
Quality of Life as Measured by the Brief Pain Inventory (BPI)
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
Measured: Post-Operative Day 3
Quality of Life as Measured by the Brief Pain Inventory (BPI)
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
Measured: Post-Operative Day 14
Total Opioid Use Prior to Hospital Discharge
Oral morphine equivalent of opioid use while in the hospital
Measured: 24 hours
Total Opioid Use End of Post-op Day 3
Total use of home opioids by pill count/ oral morphine equivalents
Measured: 72 hrs post-op
Total Opioid Use at Post-op Day 14
Total use of home opioids by pill count/ oral morphine equivalents
Measured: Post-Operative Day 14
Number of Participants With Adverse Events
Measured: Post-Operative Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2015Feb 2016

First posted2 Feb 2015 (estimated)
Study startJul 2015
Primary completionJan 2016
Study completionFeb 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02352922
Sponsor's protocol ID: 691275
Status last verified: Sep 2020
First submitted: 27 Jan 2015
Last updated: 1 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: There is not a plan to make IPD available, but aggregate data can be made available to interested correspondents

Publications

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. doi: 10.1016/s1074-3804(05)60578-6.
PubMed 11342725
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. doi: 10.1016/s0029-7844(98)00303-2.
PubMed 9840560
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;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2.
PubMed 24619479
Bergese SD, Onel E, Portillo J. Evaluation of DepoFoam((R)) bupivacaine for the treatment of postsurgical pain. Pain Manag. 2011 Nov;1(6):539-47. doi: 10.2217/pmt.11.62.
PubMed 24645765
Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) 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.
PubMed 21842428
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.
PubMed 22067185
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.
PubMed 22285545
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. doi: 10.1097/00002508-200003000-00003.
PubMed 10741813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial of Wound Infiltration With Extended-release Versus Short-acting Bupivacaine Before Laparoscopic or Robotic Hysterectomy
ClinicalTrials.gov ID: NCT02352922
Acronym / sponsor ID: 691275
Conditions: Pain, Postoperative, Surgical Procedure, Unspecified
Keywords: Laparoscopy, Robotic Surgical Procedures, Hysterectomy, Anesthetics, Local, Bupivacaine, Pain, Postoperative
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: Jul 2015
Primary completion: Jan 2016 (actual)
Study completion: Feb 2016 (actual)
First posted: 2 Feb 2015 (estimated)
Results: Posted 1 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Liposomal Bupivacaine	Experimental	Drug: Liposomal Bupivacaineextended-release bupivacaine (EXPAREL)
Bupivacaine HCl	Active comparator	Drug: Bupivacaine HClshort-acting bupivacaine

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Benign indication for surgery
Planned multiport laparoscopic or robotic assisted hysterectomy
Non-pregnant
Able to provide informed consent
Owns smartphone or computer with internet access

Key exclusion criteria (7 listed)

Planned additional procedures (e.g. incontinence surgery, prolapse repair or bowel surgery)
Contraindication to study drug
History of substance or alcohol abuse within the past 2 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Liposomal BupivacaineAlso: Exparelpre-incision infiltration with liposomal bupivacaine	Drug	Liposomal Bupivacaine
Bupivacaine HClAlso: Marcainepre-incision infiltration with bupivacaine HCl	Drug	Bupivacaine HCl

Primary outcome

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

14 secondary outcomes

NRS Pain Score at 2 Hours
Time frame: 2 hours post-op
NRS Pain Score at 4 Hours
Time frame: 4 hours post-op
NRS Pain Score at 8 Hours
Time frame: 8 hours post-op
NRS Pain Score at 16 Hours
Time frame: 16 hours post-op
NRS Pain Score Post-op Day 2
Time frame: 2 days post-op
NRS Pain Score Post-op Day 3
Time frame: 3 days post-op
NRS Pain Score Post-op Day 14
Time frame: Post-Operative Day 14
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time frame: Post-Operative Day 2
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time frame: Post-Operative Day 3
Quality of Life as Measured by the Brief Pain Inventory (BPI)
Time frame: Post-Operative Day 14
Total Opioid Use Prior to Hospital Discharge
Time frame: 24 hours
Total Opioid Use End of Post-op Day 3
Time frame: 72 hrs post-op
Total Opioid Use at Post-op Day 14
Time frame: Post-Operative Day 14
Number of Participants With Adverse Events
Time frame: Post-Operative Day 14

Results and safety

Results posted to the registry on 1 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Liposomal Bupivacaine	32	28
Bupivacaine HCl	32	28

Primary outcome: Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1).

Time frame: 24 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	Liposomal Bupivacaine n = 30	Bupivacaine HCl n = 30
Value	4.17 (2.2)	4.97 (2.6)

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Liposomal Bupivacaine	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Bupivacaine HCl	0 of 32 (0%)	0 of 32 (0%)	0 of 32

Limitations and caveats (from the sponsor): study published in JMIG. https://doi.org/10.1016/j.jmig.2016.11.002

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 11342725Saleh 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. doi: 10.1016/s1074-3804(05)60578-6.
Background: PubMed 9840560Ke 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. doi: 10.1016/s0029-7844(98)00303-2.
Background: PubMed 24619479Loizides 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;2014(3):CD007049. doi: 10.1002/14651858.CD007049.pub2.
Background: PubMed 24645765Bergese SD, Onel E, Portillo J. Evaluation of DepoFoam((R)) bupivacaine for the treatment of postsurgical pain. Pain Manag. 2011 Nov;1(6):539-47. doi: 10.2217/pmt.11.62.
Background: PubMed 21842428Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam(R) 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.
Background: PubMed 22067185Gorfine 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.
Background: PubMed 22285545Bramlett 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.
Background: PubMed 10741813Kato 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. doi: 10.1097/00002508-200003000-00003.
Individual participant dataSharing planned: Yes. There is not a plan to make IPD available, but aggregate data can be made available to interested correspondents

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Georgine Lamvu, MD, MPH principal investigator

Florida Hospital Orlando

Kenneth I Barron, MD study director

Florida Hospital Orlando

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liposomal Bupivacaine and Bupivacaine HCl in people with Pain, Postoperative and Surgical Procedure, Unspecified, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Numerical Rating Scale (NRS) Post-operative Pain Score on Post-Operative Day 1 (POD1). (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02352922, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.