Gynecologic CancerPhase 3NCT03304444
A Comparison of Exparel to Bupivacaine in TAP Block for Abdominal Gynecologic Surgery
A Phase 3 study testing Bupivacaine and liposomal bupivacaine in people with Gynecologic Cancer and Post Operative Pain, run by Abington Memorial Hospital at 1 site in United States.
Trial summary
This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gynecologic Cancer, Post Operative Pain
- What is being tested?
- Bupivacaine and liposomal bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Oct 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 to 99 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients undergoing planned exploratory laparotomy
- TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
- Consent for TAP block signed by patients preoperatively by anesthesiology
Who cannot join
- All pregnant patients
- All patients under 18 years of age
- minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
- medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Abington Hospital Jefferson Health
Abington, Pennsylvania, 19001
Mark Shahin, MD, 215-885-0220, mark.shahin@jefferson.edu
Heidi Ching, MD, 215-481-4211, heidi.ching@jefferson.edu
About this study
Official title: A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery
This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.
Read the detailed description
The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of liposomal bupivicaine that is reputed to have a much longer duration of action compares to bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also been studied in other procedures and demonstrated reduction in opioid use and median length of stay (LOS).
Currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. As Exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if TAP blocks with Exparel™ have an advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result in reduced length of stay contributing to significant hospital cost savings. Secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). Given there are no published data on the efficacy and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot study.
- Conditions
- Gynecologic Cancer, Post Operative Pain
- Being tested
- Bupivacaine, liposomal bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
bupivacaine hydrochloride used in TAP block
liposomal bupivacaineDrug
Also called Exparel
liposomal bupivacaine used in TAP block
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine HCl in TAP block | Active comparator | When performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials).
When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon. Receives: Drug: Bupivacaine |
| Liposomal Bupivicaine in TAP block | Experimental | When performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks. Receives: Drug: liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay post operatively in hospital
number of hours patient stays post operatively in hospital
Measured: through study completion, expected to be approximately 1 year in total
Secondary outcomes (1)
total opioid use post operatively in hospital
total opioid use in morphine equivalent that patient uses
Measured: through study completion, expected to be approximately 1 year in total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study startAug 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Ching, MD, Abington Memorial Hospital
- Investigators
- Heidi Ching, MD, Principal investigator, OB GYN Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304444
- Sponsor's protocol ID
- FWA00004123
- Status last verified
- Oct 2017
- First submitted
- 13 Sep 2016
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: A Comparison of Liposomal Bupivacaine to Bupivacaine HCl in Transversus Abdominis Planus Block for Abdominal Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT03304444
- Acronym / sponsor ID
- FWA00004123
- Conditions
- Gynecologic Cancer, Post Operative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Abington Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the comparison between liposomal bupivacaine versus bupivacaine HCl in Transversus Abdominis Plane blocks for gynecologic surgery on the length of stay in the hospital, total narcotic use, and overall complications rates.
Detailed description
The proposed pilot study is evaluating the use of Exparel ™ in an anesthesia protocol for patients undergoing major lower abdominal gynecologic surgery. Exparel ™ is a formulation of liposomal bupivicaine that is reputed to have a much longer duration of action compares to bupivacaine. Exparel™ has been originally demonstrated to be safe and effective in bunionectomy and hemorrhoidectomy. It has recently gained FDA approval for all surgical site infiltration including TAP (Transversus Abdominis Planus block) blocks. Exparel™ has also been studied in other procedures and demonstrated reduction in opioid use and median length of stay (LOS).
Currently, patients on the gynecologic oncology service undergoing major abdominal surgery are receiving a type of regional anesthesia using bupivacaine HCl known as a TAP block as part of an effort to decrease narcotic use post-operatively and decrease hospital length of stay. Bupivacaine has a known eight to twelve hour duration of action, thus addressing immediate post operative pain. As Exparel™ is anticipated to have a longer duration of action, the purpose of this study is to determine if TAP blocks with Exparel™ have an advantage over standard TAP blocks with bupivacaine HCl in reducing length of hospital stay in a randomized controlled trial. Our hypothesis is that TAP blocks with Exparel™ will result in reduced length of stay contributing to significant hospital cost savings. Secondary outcomes include total narcotic use (hypothesized to be reduced) and overall complication rates (hypothesized to remain unchanged). Given there are no published data on the efficacy and safety of using Exparel™ in open gynecologic abdominal surgery, this will be a pilot study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine HCl in TAP block | Active comparator | Drug: BupivacaineWhen performing a bilateral TAP with Bupivicaine 0.25% and the incision is below the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). When performing a bilateral TAP with Bupivicaine 0.25% and the incision extends above the umbilicus: 30 ml of 0.25% bupivacaine is drawn up and given on each side after identification of planes by the anesthesiologist (need 2 vials). A 3rd vial of 30 ml 0.25% bupivacaine will be drawn up and is directly infiltrated into the surgical site (above and below the fascia prior to closure of fascia) extending above the umbilicus by the surgeon. |
| Liposomal Bupivicaine in TAP block | Experimental | Drug: liposomal bupivacaineWhen performing a bilateral TAP with liposomal bupivacaine and the incision is below the umbilicus: the 20 ml vial of liposomal bupivacaine containing 266 mg, will be diluted with 20 ml of 0.25% bupivacaine (containing 50 mg of bupivacaine) and 20 ml saline (60 ml total). That total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all patients undergoing planned exploratory laparotomy
- TAP blocks placed after the laparotomy incision is closed, but before the patient is awake, and placed under ultrasound guidance with correct identification of the correct abdominal plane.
- Consent for TAP block signed by patients preoperatively by anesthesiology
Key exclusion criteria (4 listed)
- All pregnant patients
- All patients under 18 years of age
- minimally invasive surgery such as laparoscopy or robotic assisted laparoscopy
- medical contraindications to use of bupivacaine or liposomal bupivacaine such as severe hepatic and/or renal disease
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 |
|---|---|---|
| Bupivacainebupivacaine hydrochloride used in TAP block | Drug | Bupivacaine HCl in TAP block |
| liposomal bupivacaineAlso: Exparelliposomal bupivacaine used in TAP block | Drug | Liposomal Bupivicaine in TAP block |
Primary outcome
Length of stay post operatively in hospital
Time frame: through study completion, expected to be approximately 1 year in total
number of hours patient stays post operatively in hospital
1 secondary outcome
total opioid use post operatively in hospital
Time frame: through study completion, expected to be approximately 1 year in total
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
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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.
Heidi Ching, MD principal investigator
OB GYN Resident
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bupivacaine and liposomal bupivacaine in people with Gynecologic Cancer and Post Operative Pain, run by Abington Memorial Hospital 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 9 Oct 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Heidi Ching, MD (215-481-4231, heidi.ching@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay post operatively in hospital (time frame: through study completion, expected to be approximately 1 year in total). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2017.