HysterectomyPhase 4NCT03250507
Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy
A Phase 4 study testing Bupivacaine, Liposomal bupivacaine and Saline in people with Hysterectomy, run by Henry Ford Health System at 1 site in United States.
Trial summary
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Bupivacaine, Liposomal bupivacaine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2017to 30 Jan 2019
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.
Who cannot join
- Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
Read the detailed description
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
- Conditions
- Hysterectomy
- Being tested
- Bupivacaine, Liposomal bupivacaine, Saline
- Keywords
- TAP block, Liposomal bupivicaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine, Sensorcaine
0.25% bupivacaine for TAP block
Liposomal bupivacaineDrug
Also called Exparel
Exparel for TAP block
SalineDrug
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine Receives: Drug: Bupivacaine |
| Liposomal bupivacaine | Active comparator | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline.
this group will not receive bupivacaine. they receive only liposomal bupivacaine. Receives: Drug: Liposomal bupivacaine; Drug: Saline |
| Liposomal bupivacaine and bupivacaine | Experimental | Patients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine.
this group will receive the mixture of Liposomal bupivacaine and bupivacaine. Receives: Drug: Bupivacaine; Drug: Liposomal bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
Total opioid consumption
Measured: 0 - 72 hours post-operatively
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
time to first opioid given
Measured: 0 - 72 hours post-operatively
Secondary outcomes (5)
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.
Measured: 0 - 72 hours post-operatively
Length of Stay in the Hospital
Length of stay in the hospital, maximum time until discharge from the hospital
Measured: until the patient is discharged from the hospital
Number of Patients With Local Anesthetic Toxicity
Presence of local anesthetic toxicity
Measured: 0 - 72 hours post-operatively
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Presence of hemodynamic instability
Measured: 0 - 72 hours post-operatively
Pain Scores Using Visual Analogue Scale ( 0-10)
Maximum pain score 0 - 24 hr. Pain scores are reported on a scale of 0-10. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, and 7-10 = severe pain.
Measured: 0-24 postoperative pain scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start13 Mar 2017
- Primary completion30 Jan 2019
- Study completion30 Jan 2019
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 HysterectomyStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of three study groups.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Rida Alsaden, Henry Ford Health System
- Investigators
- Mohamed-Rida Alsaden, MBChB FRCPC, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03250507
- Sponsor's protocol ID
- IRB 10655
- Status last verified
- Nov 2022
- First submitted
- 5 Apr 2017
- Last updated
- 21 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will be available to only study researchers.
Publications
Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.
PubMed 33432496
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mixture of Liposomal Bupivicaine and Bupivicaine Hydrogen Chloride (HCl) May Provide Faster and Longer Lasting Analgesia in Transversus Abdominis Block for Patient Having Open Abdominal Hysterectomies
- ClinicalTrials.gov ID
- NCT03250507
- Acronym / sponsor ID
- IRB 10655
- Conditions
- Hysterectomy
- Keywords
- TAP block, Liposomal bupivicaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 13 Mar 2017 (actual)
- Primary completion
- 30 Jan 2019 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Posted 21 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effectiveness of different formulations of bupivacaine infiltrated into the transversus abdominis plane (TAP) on post-operative pain management after open abdominal hysterectomy.
Detailed description
All eligible patients who consent to the study will be randomized to one of three groups. Group 1 will receive a TAP block with 60 mL 0.25% bupivacaine. Group 2 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. Group 3 will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. Patients will be assessed in the post-anesthesia care unit (PACU) at once each on Post-operative day 1,2, and 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients will be randomized to one of three study groups.
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: BupivacainePatients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine |
| Liposomal bupivacaine | Active comparator | Drug: Liposomal bupivacaine, Drug: SalinePatients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL saline. this group will not receive bupivacaine. they receive only liposomal bupivacaine. |
| Liposomal bupivacaine and bupivacaine | Experimental | Drug: Bupivacaine, Drug: Liposomal bupivacainePatients will receive a TAP block with 20 mL liposomal bupivacaine and 40 mL 0.25% bupivacaine. this group will receive the mixture of Liposomal bupivacaine and bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective open abdominal hysterectomy with midline incision, age > 18 years, American Society of Anesthesiologist classification score (ASA classification) 1-3.
Key exclusion criteria (1 listed)
- Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any contraindication to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.
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 |
|---|---|---|
| BupivacaineAlso: Marcaine, Sensorcaine0.25% bupivacaine for TAP block | Drug | Bupivacaine, Liposomal bupivacaine and bupivacaine |
| Liposomal bupivacaineAlso: ExparelExparel for TAP block | Drug | Liposomal bupivacaine, Liposomal bupivacaine and bupivacaine |
| SalineSaline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume. | Drug | Liposomal bupivacaine |
Primary outcome
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
Time frame: 0 - 72 hours post-operatively
Total opioid consumption
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
Time frame: 0 - 72 hours post-operatively
time to first opioid given
5 secondary outcomes
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
Time frame: 0 - 72 hours post-operatively
Length of Stay in the Hospital
Time frame: until the patient is discharged from the hospital
Number of Patients With Local Anesthetic Toxicity
Time frame: 0 - 72 hours post-operatively
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Time frame: 0 - 72 hours post-operatively
Pain Scores Using Visual Analogue Scale ( 0-10)
Time frame: 0-24 postoperative pain scores
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33432496Fidkowski CW, Choksi N, Alsaden MR. A randomized-controlled trial comparing liposomal bupivacaine, plain bupivacaine, and the mixture of liposomal bupivacaine and plain bupivacaine in transversus abdominus plane block for postoperative analgesia for open abdominal hysterectomies. Can J Anaesth. 2021 Jun;68(6):773-781. doi: 10.1007/s12630-020-01911-1. Epub 2021 Jan 11.
- Individual participant dataSharing planned: No. Individual patient data will be available to only study researchers.
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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.
Mohamed-Rida Alsaden, MBChB FRCPC principal investigator
Henry Ford Hospital
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, Liposomal bupivacaine and Saline in people with Hysterectomy, run by Henry Ford Health System 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 1 inclusion and 1 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 21 Dec 2022. 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 21 Dec 2022). 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?
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg) (time frame: 0 - 72 hours post-operatively). 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?
On the ClinicalTrials.gov record for NCT03250507, 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 21 Dec 2022.