Pain, PostoperativePhase 2/3NCT02959996
Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
A Phase 2/3 study testing Liposomal bupivacaine in people with Pain, Postoperative, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 3 Nov 2017
- Phase
- Phase 2/3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Who cannot join
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores.
Read the detailed description
This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).
The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.
Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.
The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.
- Conditions
- Pain, Postoperative
- Being tested
- Liposomal bupivacaine, Placebo
- 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
liposomal bupivacaine injection in the Pfannenstiel incision
PlaceboDrug
placebo injection in the Pfannenstiel incision
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Normal saline will be infiltrated Receives: Drug: Placebo |
| Intervention | Active comparator | Liposomal bupivacaine will be infiltrated Receives: Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score With Activity
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.
2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39
Measured: at 48-hours post-operatively
Secondary outcomes (8)
Pain Score With Activity
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain.
4 patients in the placebo group and 7 patients in the liposomal bupivacaine group were discharged prior to the 72 hour assessment
Measured: at 72 -hours post-operatively
Total Opioid Use (in Morphine Equivalents)
Total opioid use (in morphine equivalents)
Measured: 72-hours post-operatively
Satisfaction With Post-operative Pain Control
PAIN OUT Tool, 0-10 scale, where 0 is not satisfied and 10 is satisfied
Measured: 48-hours post-operatively
Postoperative Hospital Length of Stay
Postoperative hospital length of stay
Measured: 0 to 96 hours postoperatively
Number of Patients With Wound Complication - Separation, Dehiscence, Infection
Wound complication - separation, dehiscence, infection
Measured: 14 days postoperatively
Number of Patients With Allergic Reaction Attributable to Local Anesthestic
incisional rash, hives, anaphylaxis
Measured: 0-96 hours postoperatively
Operative Time of Cesarean Delivery
Operative time of cesarean delivery
Measured: Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
Patient Satisfaction With Pain Management at 6w Postpartum
Phone follow up to ascertain satisfaction with pain control, Likert 5 point scale used
Measured: 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start8 Mar 2017
- Primary completion25 Sep 2017
- Study completion3 Nov 2017
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 (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malavika Prabhu, Massachusetts General Hospital
- Investigators
- William H Barth, Jr, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959996
- Sponsor's protocol ID
- 2016P002307/MGH
- Status last verified
- May 2018
- First submitted
- 4 Nov 2016
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prabhu M, Clapp MA, McQuaid-Hanson E, Ona S, O'Donnell T, James K, Bateman BT, Wylie BJ, Barth WH Jr. Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):70-78. doi: 10.1097/AOG.0000000000002649.
PubMed 29889750
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liposomal Bupivacaine at Cesarean Delivery to Decrease Post-operative Pain
- ClinicalTrials.gov ID
- NCT02959996
- Acronym / sponsor ID
- 2016P002307/MGH
- Conditions
- Pain, Postoperative
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 3 Nov 2017 (actual)
- First posted
- 9 Nov 2016 (estimated)
- Results
- Posted 27 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to test whether the use of liposomal bupivacaine at the time of cesarean delivery may decrease post-operative pain scores.
Detailed description
This study is a randomized controlled trial. A total of 80 patients will be randomized 1:1 to intervention (liposomal bupivacaine) versus control (placebo solution).
The planned intervention is the infiltration of liposomal bupivacaine (or control) at the time of fascial closure at a Pfannenstiel incision, after the delivery of the infant and repair of the hysterotomy. The procedure to instill the drug is as follows: Once the patient is in the operating room, neuraxial anesthesia will be administered per routine practice. A Pfannenstiel skin incision will be made. The usual cesarean delivery procedure will be performed at the discretion of the surgeon. Once the surgical team is about to begin fascial closure, the study drug will then be infiltrated by a member of the study team, with 50% of the study solution in subcutaneous space and 50% in the fascial plane, taking care to evenly spread the drug in the superior and inferior aspects of the incision. For the fascial infiltration, liposomal bupivacaine will be preferentially infiltrated laterally. The remainder of the cesarean delivery will proceed according to the usual fashion. At any point in the cesarean delivery, the surgeon may chose to administer or withhold ketorolac.
Post-operative pain management will be: intrathecal morphine, scheduled ketorolac 30mg IV x 24h followed by ibuprofen 600mg q6h x 24h, scheduled Tylenol 650mg q6h x 48h, and prn oxycodone 5-10mg q4h. This is the current pain management protocol for postoperative women after cesarean delivery. If Tylenol or NSAIDs are contraindicated, either due to the discretion of the clinical team or pre-existing patient contraindication, these will not be administered but are not a reason for study exclusion.
The investigators plan to enroll 80 patients into this pilot study, 40 per group. This sample size is based on prior data among women who had a cesarean delivery at this institution, and were asked to report their pain scores with activity at 48- and 72- hours after operation. With this sample size, the investigators have 80% power to detect a 1.5 point difference in pain at 48 hours, and 90% power to detect a 1.5 point difference in pain at 72 hours, and account for any protocol violations or loss to follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboNormal saline will be infiltrated |
| Intervention | Active comparator | Drug: Liposomal bupivacaineLiposomal bupivacaine will be infiltrated |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled cesarean delivery via Pfannenstiel incision;
- Planned neuraxial anesthetic with intrathecal morphine and fentanyl administration.
Key exclusion criteria (4 listed)
- Current or prior use of methadone, buprenorphine, or other opioids before cesarean delivery;
- Contraindication to neuraxial anesthetic;
- Allergy to local anesthetic;
- Planned general anesthetic.
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: Exparelliposomal bupivacaine injection in the Pfannenstiel incision | Drug | Intervention |
| Placeboplacebo injection in the Pfannenstiel incision | Drug | Placebo |
Primary outcome
Pain Score With Activity
Time frame: at 48-hours post-operatively
Pain score with activity. PAIN OUT scale, which is a 0-10 scale, where 10 is more pain. 2 patients in the liposomal bupivacaine group were discharged prior to 48 hour assessment, therefore denominator for this outcome is 37, not 39
8 secondary outcomes
Pain Score With Activity
Time frame: at 72 -hours post-operatively
Total Opioid Use (in Morphine Equivalents)
Time frame: 72-hours post-operatively
Satisfaction With Post-operative Pain Control
Time frame: 48-hours post-operatively
Postoperative Hospital Length of Stay
Time frame: 0 to 96 hours postoperatively
Number of Patients With Wound Complication - Separation, Dehiscence, Infection
Time frame: 14 days postoperatively
Number of Patients With Allergic Reaction Attributable to Local Anesthestic
Time frame: 0-96 hours postoperatively
Operative Time of Cesarean Delivery
Time frame: Intraoperative time measurement, from skin incision to skin closure. Measured within 24h of admission.
Patient Satisfaction With Pain Management at 6w Postpartum
Time frame: 6 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29889750Prabhu M, Clapp MA, McQuaid-Hanson E, Ona S, O'Donnell T, James K, Bateman BT, Wylie BJ, Barth WH Jr. Liposomal Bupivacaine Block at the Time of Cesarean Delivery to Decrease Postoperative Pain: A Randomized Controlled Trial. Obstet Gynecol. 2018 Jul;132(1):70-78. doi: 10.1097/AOG.0000000000002649.
- Individual participant dataSharing planned: No
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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.
William H Barth, Jr, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Liposomal bupivacaine in people with Pain, Postoperative, run by Massachusetts General 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 2 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: finished, as of the sponsor's last update on 27 Aug 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 27 Aug 2018). 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?
Pain Score With Activity (time frame: at 48-hours post-operatively). 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 NCT02959996, which also lists 1 linked publication.
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 27 Aug 2018.