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TAP Block With Liposomal Bupivacaine Versus Bupivacaine in Robotic Hysterectomy

Ultrasound Guided Subcostal Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine vs Bupivacaine in Robotic Hysterectomy Patients: A Prospective Randomized Study.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02289079
Enrollment
60
Registered
2014-11-13
Start date
2013-06-30
Completion date
2014-10-31
Last updated
2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain

Brief summary

The purpose of the study is to compare pain control after robotic hysterectomy surgery using either liposomal bupivacaine or Bupivacaine when injected during a transversus abdominis plane (TAP) block. Robotic hysterectomy is when a patient is electively having robotic assisted removal of one's uterus. Both medications liposomal bupivacaine and Bupivacaine are standard of care in these types of surgeries.

Detailed description

Treatment technique: The patient will be in the supine position. The transversus abdominis muscle layer will be identified with the ultrasound. Using sterile technique, skin infiltration with 2% lidocaine will occur, 2 cm medial to the ultrasound probe. An 22g Nerve block needle will then be inserted and advanced under ultrasound guidance until it is below the fascial covering of the transversus abdominis muscle layer. Gentle aspiration for air, or blood will be performed and either 30 cc of 0.25% bupivacaine with 1/200,000 parts epinephrine or 30 mL of liposomal bupivacaine mixed 1:1 with normal saline will be injected under ultrasound guidance. For each 5cc of local anesthetic injected, aspiration will be performed. Upon completion of the injection, the needle will then be removed. This will then be completed on the contralateral side. The patient will be monitored in the preoperative area until he/she is brought into the operating room for their procedure. When the operation is complete the patient will either be discharged home or brought to the ward where each day a member of the research team will evaluate the patient for signs of complications and ask the patient their minimum and maximum pain score. If patients have met criterion for discharge to home including pain \<4/10, independence of intravenous analgesia, and are stable for discharge medically, but are awaiting placement, the time of discharge for the purposes of the study will be the day they have met such criterion as opposed to the day of actual discharge, as this can vary depending on patient placement. If the patient is discharged prior to 72 hours post injection, then the patient will receive one phone call at 24 hours post injection, 48 hours post injection , and 72 hours post injection +/- 5 hours. During this phone call the patient will be asked about pain score, narcotic use, overall satisfaction via a recorded patient questionnaire, quality of recovery via a quality of recovery survey, and assessed if any adverse events have occurred. Adequate analgesia will be defined as \<3 VAS at rest, and if VAS is greater than 3 adjustments in oral or intravenous pain medications will be given as determined by the nurse.

Interventions

DRUGBupivacaine
DRUGliposomal bupivacaine

Sponsors

University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* those who present for elective robotic assisted hysterectomy

Exclusion criteria

* non english speaking * chronic pain * on opioids greater than 1 weeks * chronic anticoagulation * allergy to local anesthetics * use of spinal or epidural for surgery * lack of patient cooperation * contraindication to regional anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Post Operative Opioid Use0-72 hours after injectionTo determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block

Secondary

MeasureTime frameDescription
Numerical Rating Scale48-72 hoursThis was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.
Post Operative Length of Stayup to 30 days after surgeryTo determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block
Patient Satisfaction as Assessed Via Patient Surveyassessed at 72 hours after injectionTo determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.

Participant flow

Participants by arm

ArmCount
Liposomal Bupivacaine TAP
these patients receive a subcostal TAP with liposomal bupivacaine liposomal bupivacaine
28
Bupivacaine TAP
These patients receive a subcostal TAP with bupivacaine Bupivacaine
30
Total58

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up01
Overall StudyPhysician Decision20

Baseline characteristics

CharacteristicTotalBupivacaine TAPLiposomal Bupivacaine TAP
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
13 Participants5 Participants8 Participants
Age, Categorical
Between 18 and 65 years
45 Participants25 Participants20 Participants
Region of Enrollment
United States
58 participants30 participants28 participants
Sex: Female, Male
Female
58 Participants30 Participants28 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
weight93.5 kilograms
STANDARD_DEVIATION 30.2
98.5 kilograms
STANDARD_DEVIATION 34.2
89.3 kilograms
STANDARD_DEVIATION 25.1

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 280 / 30
serious
Total, serious adverse events
0 / 280 / 30

Outcome results

Primary

Post Operative Opioid Use

To determine if liposomal bupivacaine provides decreased narcotic use when compared to bupivacaine when injected in a TAP block

Time frame: 0-72 hours after injection

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine TAPPost Operative Opioid Use24.9 micrograms of fentanyl equivalents
Bupivacaine TAPPost Operative Opioid Use51.7 micrograms of fentanyl equivalents
Secondary

Numerical Rating Scale

This was a measure of patient's reported pain on a 0-10 verbal numerical rating scale. 10 being worst pain. The maximal value for the time period 48-72 hours was chosen as the maximal pain during that time period.

Time frame: 48-72 hours

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine TAPNumerical Rating Scale3 scores on a scale
Bupivacaine TAPNumerical Rating Scale5 scores on a scale
Secondary

Patient Satisfaction as Assessed Via Patient Survey

To determine if liposomal bupivacaine improves quality of recovery post-operatively when compared to bupivacaine when injected in a TAP block via a patient survey either in person or via telephone.

Time frame: assessed at 72 hours after injection

ArmMeasureValue (NUMBER)
Liposomal Bupivacaine TAPPatient Satisfaction as Assessed Via Patient Survey26 participants satisfied with pain control
Bupivacaine TAPPatient Satisfaction as Assessed Via Patient Survey24 participants satisfied with pain control
Secondary

Post Operative Length of Stay

To determine if liposomal bupivacaine provides decreased length of stay when compared to bupivacaine when injected in a TAP block

Time frame: up to 30 days after surgery

ArmMeasureValue (MEAN)Dispersion
Liposomal Bupivacaine TAPPost Operative Length of Stay11 HoursStandard Deviation 9.1
Bupivacaine TAPPost Operative Length of Stay17 HoursStandard Deviation 13.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026