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Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction

Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03700970
Enrollment
60
Registered
2018-10-09
Start date
2019-06-13
Completion date
2021-03-30
Last updated
2022-01-24

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

Conditions

Anesthesia, Breast Reconstruction, Transverse Abdominis Plane Block

Brief summary

This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.

Detailed description

Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway. This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl). Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally. Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).

Interventions

DRUGRegular bupivacaine

20mL of 0.25% bupivacaine injected on each side.

DRUGLiposomal bupivacaine

20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.

Sponsors

Vanderbilt University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Participants and plastic surgeons will be blinded to the study treatment arm

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

1. age between 18-85 years 2. males or females 3. plastic surgery for abdominally-based free flap breast reconstruction.

Exclusion criteria

1. those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine) 2. those with anatomic contra-indications to performing a TAP block 3. those unwilling to participate in follow-up assessments 4. vulnerable populations 5. chronic pain or associated diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)Postoperative day (POD) 1 to 7Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

Secondary

MeasureTime frameDescription
Time to First Opiate Use0-29.8 hours post operationTime from end of surgery to time of first opioid intake measured in hours
Time to Return of Bowel Function1 to 4 days post operationMean time in days at which patients had a return of bowel movement post op
Length of Stay1 to 4 daysLength of hospital stay post operatively
Ambulation1 day post opTime to first ambulate post op (in days)
Pain MeasurePost operative day (POD) 1 to 7Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
Non Narcotic Pain Medication Intake: CyclobenzaprinePost op day 1 to 7The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
Non Narcotic Pain Medication Intake: GabapentinPost op day 1 to 7The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
Non Narcotic Pain Medication Intake: Celebrexpost op day 1 to 7The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
Non Narcotic Pain Medication Intake: OndansetronPost op day 1 to 7The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
Non-narcotic Pain Medication Intake: AcetaminophenPost op day 1 to 7The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization

Countries

United States

Participant flow

Participants by arm

ArmCount
Transversus Abdominis Plane (TAP) Block With Liposomal Bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side. Liposomal bupivacaine: 20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
30
Transversus Abdominis Plane (TAP) Block With Regular Bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia. Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest. The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane. 20mL of 0.25% bupivacaine injected on each side. Regular bupivacaine: 20mL of 0.25% bupivacaine injected on each side.
30
Total60

Baseline characteristics

CharacteristicTransversus Abdominis Plane (TAP) Block With Liposomal BupivacaineTotalTransversus Abdominis Plane (TAP) Block With Regular Bupivacaine
Age, Continuous53 years
STANDARD_DEVIATION 9.5
52.6 years
STANDARD_DEVIATION 9.6
52.2 years
STANDARD_DEVIATION 9.8
Body mass index (BMI)29.6 kg/m^2
STANDARD_DEVIATION 5.3
29.9 kg/m^2
STANDARD_DEVIATION 4.8
30.2 kg/m^2
STANDARD_DEVIATION 4.3
Deep Inferior Epigastric Artery Perforator (DIEP) Laterality
Bilateral DIEP
21 Participants44 Participants23 Participants
Deep Inferior Epigastric Artery Perforator (DIEP) Laterality
Unilateral DIEP
9 Participants16 Participants7 Participants
Diabetic8 Participants14 Participants6 Participants
DIEP timing
Delayed DIEP
25 Participants49 Participants24 Participants
DIEP timing
Immediate DIEP
5 Participants11 Participants6 Participants
History of hormonal therapy (HT)
Current HT
13 Participants23 Participants10 Participants
History of hormonal therapy (HT)
None
12 Participants29 Participants17 Participants
History of hormonal therapy (HT)
Prior HT
5 Participants8 Participants3 Participants
Hypercoagulable states1 Participants1 Participants0 Participants
Hypertension (HTN)9 Participants19 Participants10 Participants
Immunosuppressive medications1 Participants2 Participants1 Participants
Prior chemotherapy10 Participants20 Participants10 Participants
Prior radiation6 Participants16 Participants10 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
Female
30 Participants60 Participants30 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
Smoker1 Participants1 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 30
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)

Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents

Time frame: Postoperative day (POD) 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 312.2 mg morphine equivalentsStandard Deviation 15.3
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 57.33 mg morphine equivalentsStandard Deviation 8.48
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 220.7 mg morphine equivalentsStandard Deviation 20.5
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 65.1 mg morphine equivalentsStandard Deviation 7
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 48.2 mg morphine equivalentsStandard Deviation 8.7
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 73.8 mg morphine equivalentsStandard Deviation 5.9
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 119.8 mg morphine equivalentsStandard Deviation 18.8
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 74.9 mg morphine equivalentsStandard Deviation 7.7
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 123.6 mg morphine equivalentsStandard Deviation 17.5
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 225.2 mg morphine equivalentsStandard Deviation 23.5
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 312.8 mg morphine equivalentsStandard Deviation 11.7
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 48.8 mg morphine equivalentsStandard Deviation 9.3
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 56.52 mg morphine equivalentsStandard Deviation 8.51
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)POD 66.8 mg morphine equivalentsStandard Deviation 7.7
Secondary

Ambulation

Time to first ambulate post op (in days)

Time frame: 1 day post op

ArmMeasureValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineAmbulation1 daysStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineAmbulation1 daysStandard Deviation 0
Secondary

Length of Stay

Length of hospital stay post operatively

Time frame: 1 to 4 days

ArmMeasureValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineLength of Stay2.43 DAYSStandard Deviation 0.77
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineLength of Stay2.23 DAYSStandard Deviation 0.43
Secondary

Non-narcotic Pain Medication Intake: Acetaminophen

The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization

Time frame: Post op day 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 41937 milligramsStandard Deviation 1239
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 12630 milligramsStandard Deviation 803
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 32160 milligramsStandard Deviation 1334
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 61903 milligramsStandard Deviation 1179
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 51757 milligramsStandard Deviation 1159
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 71887 milligramsStandard Deviation 1174
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 22937 milligramsStandard Deviation 972
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 71588 milligramsStandard Deviation 1171
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 22868 milligramsStandard Deviation 799
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 31945 milligramsStandard Deviation 1342
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 41722 milligramsStandard Deviation 116
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 51755 milligramsStandard Deviation 1130
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 12840 milligramsStandard Deviation 503
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon-narcotic Pain Medication Intake: AcetaminophenPOD 61755 milligramsStandard Deviation 1067
Secondary

Non Narcotic Pain Medication Intake: Celebrex

The total use of the non-narcotic pain medication celebrex was recorded during hospitalization

Time frame: post op day 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 2193 milligramsStandard Deviation 146
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 420 milligramsStandard Deviation 61
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 1200 milligramsStandard Deviation 144
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 520 milligramsStandard Deviation 61
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 367 milligramsStandard Deviation 132
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 613 milligramsStandard Deviation 51
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 713 milligramsStandard Deviation 51
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 60 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 70 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 1187 milligramsStandard Deviation 138
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 2203 milligramsStandard Deviation 119
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 360 milligramsStandard Deviation 113
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 40 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CelebrexPOD 50 milligramsStandard Deviation 0
Secondary

Non Narcotic Pain Medication Intake: Cyclobenzaprine

The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization

Time frame: Post op day 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 32.5 milligramsStandard Deviation 4.9
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 53.7 milligramsStandard Deviation 7.2
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 10.5 milligramsStandard Deviation 1.5
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 64 milligramsStandard Deviation 8.3
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 22 milligramsStandard Deviation 4.3
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 73 milligramsStandard Deviation 6.8
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 43.7 milligramsStandard Deviation 8.1
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 72.2 milligramsStandard Deviation 5
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 21.2 milligramsStandard Deviation 4.1
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 31.5 milligramsStandard Deviation 4.4
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 41.7 milligramsStandard Deviation 4.8
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 51.8 milligramsStandard Deviation 4.8
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 61.8 milligramsStandard Deviation 4.8
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: CyclobenzaprinePOD 11.2 milligramsStandard Deviation 5.5
Secondary

Non Narcotic Pain Medication Intake: Gabapentin

The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization

Time frame: Post op day 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 5537 milligramsStandard Deviation 451
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 3680 milligramsStandard Deviation 489
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 1730 milligramsStandard Deviation 315
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 6503 milligramsStandard Deviation 453
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 4603 milligramsStandard Deviation 454
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 7457 milligramsStandard Deviation 449
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 2807 milligramsStandard Deviation 358
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 7527 milligramsStandard Deviation 445
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 4517 milligramsStandard Deviation 371
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 1750 milligramsStandard Deviation 298
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 2813 milligramsStandard Deviation 356
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 5583 milligramsStandard Deviation 397
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 6560 milligramsStandard Deviation 443
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: GabapentinPOD 3577 milligramsStandard Deviation 378
Secondary

Non Narcotic Pain Medication Intake: Ondansetron

The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization

Time frame: Post op day 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 30.27 milligramsStandard Deviation 1.46
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 50 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 20.4 milligramsStandard Deviation 1.6
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 60 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 40 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 70 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 11.3 milligramsStandard Deviation 2.6
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 70 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 12.3 milligramsStandard Deviation 3.3
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 20.4 milligramsStandard Deviation 1.2
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 30.27 milligramsStandard Deviation 1.01
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 40 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 50 milligramsStandard Deviation 0
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineNon Narcotic Pain Medication Intake: OndansetronPOD 60 milligramsStandard Deviation 0
Secondary

Pain Measure

Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).

Time frame: Post operative day (POD) 1 to 7

ArmMeasureGroupValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 32.9 score on a scaleStandard Deviation 2.3
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 52.6 score on a scaleStandard Deviation 2.2
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 22 score on a scaleStandard Deviation 1.7
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 62.3 score on a scaleStandard Deviation 2.1
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 42.9 score on a scaleStandard Deviation 2.2
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 72.3 score on a scaleStandard Deviation 2.3
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacainePain MeasurePOD 12.43 score on a scaleStandard Deviation 1.98
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 72.8 score on a scaleStandard Deviation 2.5
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 12.93 score on a scaleStandard Deviation 2.8
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 23.1 score on a scaleStandard Deviation 3
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 33.1 score on a scaleStandard Deviation 2.5
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 43.1 score on a scaleStandard Deviation 2.7
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 53.1 score on a scaleStandard Deviation 2.6
Transversus Abdominis Plane (TAP) Block With Regular BupivacainePain MeasurePOD 63.2 score on a scaleStandard Deviation 2.7
Secondary

Time to First Opiate Use

Time from end of surgery to time of first opioid intake measured in hours

Time frame: 0-29.8 hours post operation

ArmMeasureValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineTime to First Opiate Use12.4 hoursStandard Deviation 17.4
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineTime to First Opiate Use8.2 hoursStandard Deviation 19.8
Secondary

Time to Return of Bowel Function

Mean time in days at which patients had a return of bowel movement post op

Time frame: 1 to 4 days post operation

ArmMeasureValue (MEAN)Dispersion
Transversus Abdominis Plane (TAP) Block With Liposomal BupivacaineTime to Return of Bowel Function2.62 daysStandard Deviation 0.97
Transversus Abdominis Plane (TAP) Block With Regular BupivacaineTime to Return of Bowel Function2.58 daysStandard Deviation 0.97

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