BupivacainePhase 4NCT03353363
Wound Infiltration of Liposomal Bupivacaine v Plain Bupivacaine for Post-Op Pain Control in Elective Cesarean Delivery
A Phase 4 study testing Bupivacaine and Liposomal bupivacaine in people with Bupivacaine and Pain, Postoperative, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bupivacaine, Pain, Postoperative
- What is being tested?
- Bupivacaine and Liposomal bupivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2017to 18 Feb 2019
- Phase
- Phase 4
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA I or II women with uncomplicated singleton pregnancies
- ≥37 weeks gestation
- ≥18 years old presenting
- Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
- Able to provide informed consent.
Who cannot join
- Subject is not a candidate for a spinal anesthetic
- Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)
- Subject is on chronic opioids.
- Subject is an ASA class III or higher.
- Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,
- Subject has hepatic or renal impairment that is concerning, as determined by the surgeon or anesthesiologist.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
Brian M Fitzgerald, MD, 210-916-8666, brian.m.fitzgerald.mil@mail.mil
About this study
Official title: A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial
Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.
Read the detailed description
Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment.
A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.
- Conditions
- Bupivacaine, Pain, Postoperative
- Being tested
- Bupivacaine, Liposomal bupivacaine, Placebos
- Keywords
- cesarean delivery, liposomal bupivacaine, Exparel, bupivacaine, wound infiltration
- 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
After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion.
Liposomal bupivacaineDrug
Also called Exparel
After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion.
PlacebosDrug
After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Subject will receive 20ml of normal saline infiltration Receives: Drug: Placebos |
| Plain Bupivacaine | Experimental | Subject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg) Receives: Drug: Bupivacaine |
| Liposomal Bupivacaine | Experimental | Subject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Analgesia
VAS pain intensity scores (at rest)
Measured: Thru 24 hours
Post-operative Analgesia
VAS pain intensity scores (at rest)
Measured: Thru 48 hours
Secondary outcomes (8)
Opioid use in the post-operative period
Post-operative opioid consumption
Measured: Thru 72 hours
Length of Stay (LOS)
Reduction in LOS
Measured: Thru 72 hours
Time to first ambulation
Time to ambulation
Measured: Thru 72 hours
Breast feeding initiation
Time to breast feeding initiation
Measured: Thru 72 hours
Sole breastfeeding
Percentage of subjects solely breastfeeding at the time of discharge
Measured: Thru 72 hours
Increased operative time
Increased operative time for cesarean delivery
Measured: Thru 72 hours
Pain control at 2 hours post-cesarean delivery
VAS pain intensity at 2 hours
Measured: Thru 2 hours
Wound Complication
Wound complication
Measured: 14days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start18 Oct 2017
- Primary completion18 Oct 2018 (estimated)
- Study completion18 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BupivacaineStudies 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
- Model description
- Parallel Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Brian M. Fitzgerald, MD, Brooke Army Medical Center
- Investigators
- Brian M Fitzgerald, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353363
- Sponsor's protocol ID
- C.2017.156
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Post-Incisional Wound Infiltration of Liposomal Bupivacaine to Plain Bupivacaine for Post-Operative Pain Control in Elective Cesarean Delivery: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03353363
- Acronym / sponsor ID
- C.2017.156
- Conditions
- Bupivacaine, Pain, Postoperative
- Keywords
- cesarean delivery, liposomal bupivacaine, Exparel, bupivacaine, wound infiltration
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 18 Oct 2017 (actual)
- Primary completion
- 18 Oct 2018 (estimated)
- Study completion
- 18 Feb 2019 (estimated)
- First posted
- 27 Nov 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.
Randomized double blind placebo controlled trial to compare the post-operative pain control advantages of post-incisional wound infiltration with liposomal bupivacaine to plain bupivacaine in patients presenting for elective caesarean delivery.
Detailed description
Participants will include women with uncomplicated singleton pregnancies, ≥37 weeks gestation, ≥18 years old presenting and presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM). Exclusion criteria include patients: not receiving a spinal anesthetic, receiving a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural narcotics, intravenous narcotics, etc), on chronic opioids, American Society of Anesthesiologist (ASA) physical status class III or higher (Note: An ASA I patient is defined as a normal healthy patient, an ASA II patient is defined as a patient with mild systemic disease and any patient that with severe systemic disease or a disease that is incapacitating would be classified as an ASA III or higher) or those that have known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation, and any subject with hepatic or renal impairment.
A three-arm study will be used: (a) control group (placebo of normal saline) (b) plain bupivacaine group and (c) liposomal bupivacaine group. After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one of the three solutions will be infiltrated into the wound by the obstetrician team in a standardized fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: PlacebosSubject will receive 20ml of normal saline infiltration |
| Plain Bupivacaine | Experimental | Drug: BupivacaineSubject will receive 20ml of 0.5% plain bupivacaine infiltration (100mg) |
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaineSubject will receive 20ml of liposomal bupivacaine infiltration (266mg) non-expanded |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ASA I or II women with uncomplicated singleton pregnancies
- ≥37 weeks gestation
- ≥18 years old presenting
- Presenting for elective caesarean delivery with a planned spinal anesthetic with a standardized amount of intrathecal morphine (ITM).
- Able to provide informed consent.
Key exclusion criteria (6 listed)
- Subject is not a candidate for a spinal anesthetic
- Subject receives a spinal anesthetic that required supplemental intraoperative pain medications (ketamine, epidural local anesthetic, epidural narcotics, intravenous narcotics, etc)
- Subject is on chronic opioids.
- Subject is an ASA class III or higher.
- Subject has a known hypersensitivity to bupivacaine hydrochloride, amide-type local anesthetics, or any component of the formation,
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 |
|---|---|---|
| BupivacaineAfter patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion. | Drug | Plain Bupivacaine |
| Liposomal bupivacaineAlso: ExparelAfter patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion. | Drug | Liposomal Bupivacaine |
| PlacebosAfter patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion. | Drug | Normal Saline |
Primary outcome
Post-operative Analgesia
Time frame: Thru 24 hours
VAS pain intensity scores (at rest)
Post-operative Analgesia
Time frame: Thru 48 hours
VAS pain intensity scores (at rest)
8 secondary outcomes
Opioid use in the post-operative period
Time frame: Thru 72 hours
Length of Stay (LOS)
Time frame: Thru 72 hours
Time to first ambulation
Time frame: Thru 72 hours
Breast feeding initiation
Time frame: Thru 72 hours
Sole breastfeeding
Time frame: Thru 72 hours
Increased operative time
Time frame: Thru 72 hours
Pain control at 2 hours post-cesarean delivery
Time frame: Thru 2 hours
Wound Complication
Time frame: 14days post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2018.
- Individual participant dataSharing planned: Yes
Related trials for Bupivacaine
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
Not yet recruitingPhase 4
Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine in Ultrasound-Guided Sphenopalatine Ganglion Block for Functional Endoscopic Sinus Surgery
Post Operative Pain, Emergence Agitation
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
RecruitingPhase 4
Post-Operative Pain Relief: Zynrelef or Periarticular Injections in RATKA
Periarticular Block, Osteoarthritis (OA)
Recruiting
Bupivacaine-Lidocaine vs Bupivacaine for Ultrasound-Guided Popliteal Sciatic Nerve Block
Lower Extremity, Nerve Block
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.
Brian M Fitzgerald, MD principal investigator
Brooke Army Medical Center
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 Bupivacaine and Liposomal bupivacaine in people with Bupivacaine and Pain, Postoperative, run by Brooke Army Medical Center 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 5 inclusion and 6 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 18 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brian M Fitzgerald, MD (210-916-8666, brian.m.fitzgerald.mil@mail.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Analgesia (time frame: Thru 24 hours). The study lists 2 primary outcomes in all. 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 18 Jan 2018.