CompletedNCT03250507Updated Dec 21, 2022Results posted

Mixture of Liposomal Bupivacaine and Bupivacaine for TAP Block for Open Hysterectomy

A Phase 4 interventional study of Bupivacaine and Liposomal bupivacaine in Hysterectomy, sponsored by Henry Ford Health System. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-21.

Sponsored by Henry Ford Health System · Phase 4, Interventional, and Treatment

Phase: Phase 4
Study type: Interventional
Enrollment: 90
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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 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 studied

Hysterectomy

Keywords

TAP block
Liposomal bupivicaine

In context

Lead sponsor

Henry Ford Health System is the lead sponsor of 303 studies on the registry; 50 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 26 (70%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Elective open abdominal hysterectomy with midline incision, age > 18 years, classification score (ASA classification) 1-3.

Exclusion criteria

Exclusion Criteria:

Patient with a chronic pain condition, major unexpected surgical complication, unexpected prolonged intubation, patient refusal, local anesthetic allergy, any to regional anesthesia, greater than 2 attempts by resident and greater than 1 attempt by staff anesthesiologist for TAP block.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status: The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Contraindication: A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 90 participants (actual)

Study arms

Active comparator
Bupivacaine
Patients will receive a TAP block with 60 mL 0.25% bupivacaine. this group will not receive Liposomal bupivacaine
Drug: Bupivacaine
Active comparator
Liposomal bupivacaine
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.
Drug: Liposomal bupivacaine · Drug: Saline
Experimental
Liposomal bupivacaine and bupivacaine
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.
Drug: Bupivacaine · Drug: Liposomal bupivacaine

Interventions

DrugBupivacaine
0.25% bupivacaine for TAP block
Also known as: Marcaine, Sensorcaine
DrugLiposomal bupivacaine
Exparel for TAP block
Also known as: Exparel
DrugSaline
Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.

What researchers measure

Primary outcomes

Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
Total opioid consumption
Time frame: 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
Time frame: 0 - 72 hours post-operatively

Secondary outcomes

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.
Time frame: 0 - 72 hours post-operatively
Length of Stay in the Hospital
Length of stay in the hospital, maximum time until discharge from the hospital
Time frame: until the patient is discharged from the hospital
Number of Patients With Local Anesthetic Toxicity
Presence of local anesthetic toxicity
Time frame: 0 - 72 hours post-operatively
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Presence of hemodynamic instability
Time frame: 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.
Time frame: 0-24 postoperative pain scores

Results

Posted Dec 21, 2022

Participant flow

Participant flow — Overall Study
Milestone	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Started	30	30	30
Completed	30	30	30
Not completed	0	0	0

Outcome measures

PrimaryTotal Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)

Total opioid consumption

Time frame:: 0 - 72 hours post-operatively
Reported as:: Median · mg morphine equivalents

Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)
mg morphine equivalents	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Total Opioid Consumption During the First 72 Hours Postoperatively as Measured in Morphine Equivalents (mg)	208 (155 to 270)	203 (153 to 283)	202 (116 to 325)

PrimaryTime to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given

time to first opioid given

Time frame:: 0 - 72 hours post-operatively
Reported as:: Median · minutes

Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given
minutes	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Time to First Opioid Consumption as Measured in Hours Until the First Dose of Breakthrough Opioid Medication Given	51 (28 to 66)	63 (44 to 102)	51 (24 to 84)

SecondaryPatient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied

Patient satisfaction post-operatively. The number of patients who were very satisfied is reported.

Time frame:: 0 - 72 hours post-operatively
Reported as:: Number · participants

Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied
participants	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Patient Satisfaction Using 3 Point Scale - Very Satisfied, Satisfied, Not Satisfied	9	13	9

SecondaryLength of Stay in the Hospital

Length of stay in the hospital, maximum time until discharge from the hospital

Time frame:: until the patient is discharged from the hospital
Reported as:: Median · hours

Length of Stay in the Hospital
hours	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Length of Stay in the Hospital	79 (61 to 122)	82 (72 to 102)	80 (76 to 107)

SecondaryNumber of Patients With Local Anesthetic Toxicity

Presence of local anesthetic toxicity

Time frame:: 0 - 72 hours post-operatively
Reported as:: Count of participants · Participants

Number of Patients With Local Anesthetic Toxicity
Participants	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Number of Patients With Local Anesthetic Toxicity	0	0	0

SecondaryNumber of Patients With Hypotension < 60 mmHg Mean Arterial Pressure

Presence of hemodynamic instability

Time frame:: 0 - 72 hours post-operatively
Reported as:: Count of participants · Participants

Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure
Participants	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Number of Patients With Hypotension < 60 mmHg Mean Arterial Pressure	0	1	5

SecondaryPain 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.

Time frame:: 0-24 postoperative pain scores
Reported as:: Median · units on a scale

Pain Scores Using Visual Analogue Scale ( 0-10)
units on a scale	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine
Pain Scores Using Visual Analogue Scale ( 0-10)	8 (7 to 9)	7 (6 to 7)	7 (5 to 8)

Adverse events

Collected over 72 hours. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Bupivacaine	0/30 (0%)	0/30 (0%)	0/30 (0%)
Liposomal Bupivacaine	0/30 (0%)	0/30 (0%)	0/30 (0%)
Liposomal Bupivacaine and Bupivacaine	0/30 (0%)	0/30 (0%)	0/30 (0%)

Baseline characteristics

13 patients were excluded from study analysis due to meeting exclusion criteria. N=25 in group Bupi, N = 27 in group Liposomal bupi, and N=25 in group liposomal bupi and bupi. 20 patients were discharged within 72 hr. Data is given for those in the hospital for 24 hr periods. For the period 24-48 hr, n = 24 in group bupivacaine, n = 26 in group liposomal, n = 25 in group mixture. For the period 48-72 hr, n = 18 for group bupivacaine, n = 20 for group liposomal, and n = 19 for group mixture. \*

Age, Categorical
Age, Categorical(Participants)	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine	Total
<=18 years	0	0	0	0
Between 18 and 65 years	30	30	30	90
>=65 years	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine	Total
Female	30	30	30	90
Male	0	0	0	0

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine	Total
Count of participants	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	Bupivacaine	Liposomal Bupivacaine	Liposomal Bupivacaine and Bupivacaine	Total
United States	30	30	30	90

Study locations

1 site

Henry Ford Hospital
Detroit, Michigan 48202, United States

References and documents

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 documents

Protocol and statistical analysis plan ↗ · Jun 22, 2016

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — Individual patient data will be available to only study researchers.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2017 to primary completion in Jan 2019, 22 months.

Results were first posted in Dec 2022, 3 years 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Apr 5, 2017
First posted: Aug 15, 2017
StartActual: Mar 13, 2017
Primary completionActual: Jan 30, 2019
CompletionActual: Jan 30, 2019
Results first posted: Dec 21, 2022
Last update: Dec 21, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03250507
Lead sponsor: Henry Ford Health System
Responsible party: Mohamed Rida Alsaden (Anesthesiologist, Henry Ford Health System) — Principal investigator
First posted: Aug 15, 2017
Start date: Mar 13, 2017
Primary completion: Jan 30, 2019
Completion: Jan 30, 2019
Results posted: Dec 21, 2022
Last update: Dec 21, 2022

Study contacts

Mohamed-Rida Alsaden, MBChB FRCPC

principal investigator · Henry Ford Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Bupivacaine · Liposomal Bupivacaine

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