Skip to content

Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02996227
Enrollment
514
Registered
2016-12-19
Start date
2016-12-31
Completion date
2019-10-31
Last updated
2024-01-31

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

Conditions

Major Abdominal Surgery, Pain, Postoperative

Brief summary

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Detailed description

The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Interventions

PROCEDURETAP block

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

PROCEDUREEpidural analgesia

Epidural catheters will be inserted preoperatively.

DRUGEXPAREL

Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.

DRUGBupivacaine

Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.

Sponsors

The Cleveland Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

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

Inclusion criteria

* Written informed consent * 18-85 years old * ASA Physical Status 1-3 * Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries * Anticipated hospitalization of three nights * Expected requirement for parenteral opioids for at least 72 hours for postoperative pain * Able to use IV PCA systems.

Exclusion criteria

* Hepatic disease, e.g. twice the normal levels of liver enzymes * Kidney disease, e.g. twice the normal level of serum creatinine * Bupivacaine sensitivity or known allergy * Women who are pregnant or breastfeeding * Anticoagulants considered to be a contraindication for epidural or TAP blocks. * Surgeries with high port sites will be excluded

Design outcomes

Primary

MeasureTime frameDescription
Total Opioid ConsumptionDuring the 72 hours after discharge from the PACU.Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.
VRS Pain ScoreThe Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours

Secondary

MeasureTime frameDescription
Opioid-related Side EffectThe first, second and third postoperative morningsWe will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.
Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.Data was recorded at 15-s intervals during the initial 72 postoperative hours.Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP \<65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours.
Cumulative Duration of ActivityDuring the initial 72 postoperative hours.defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.
Quality of Recovery After AnesthesiaThe first and third postoperative morningsQuality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = none of the time \[poor\] to 10 = all of the time \[excellent\]; Conversely, for negative items, 10 = none of the time \[excellent\] to 0 = all of the time \[poor\]. Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).
Length of Hospital StayFrom date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeksThe length of hospital stay will be measured as days.

Other

MeasureTime frameDescription
Persistent Postoperative Incisional Pain- MBPI Pain IntensityAt the 90-day follow upDefined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = no pain and 10 = pain as bad as you can imagine.; and for interference items, 0 = does not interfere and 10 = interferes completely. The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).
Duration of HypoxemiaData was recorded at 15-s intervals during the initial 72 postoperative hours.ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%.
Persistent Postoperative Incisional Pain- MBPI Pain InterferenceAt the 90-day follow upDefined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = no pain and 10 = pain as bad as you can imagine.; and for interference items, 0 = does not interfere and 10 = interferes completely. The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).

Countries

United States

Participant flow

Participants by arm

ArmCount
TAP Block With Exparel
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel) TAP block: Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure. EXPAREL: Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.
255
Epidural Analgesia With Bupivacaine
Epidural catheters with an infusion of Bupivacaine standard solution without additives Epidural analgesia: Epidural catheters will be inserted preoperatively. Bupivacaine: Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.
243
Total498

Baseline characteristics

CharacteristicTAP Block With ExparelTotalEpidural Analgesia With Bupivacaine
Age, Continuous55 years
STANDARD_DEVIATION 14
55 years
STANDARD_DEVIATION 14
56 years
STANDARD_DEVIATION 14
ASA Status
I
2 Participants4 Participants2 Participants
ASA Status
II
70 Participants137 Participants67 Participants
ASA Status
III
171 Participants338 Participants167 Participants
ASA Status
IV
12 Participants18 Participants6 Participants
ASA Status
Unknown
0 Participants1 Participants1 Participants
Procedure type
Laparoscopic
67 Participants129 Participants62 Participants
Procedure type
Open
188 Participants369 Participants181 Participants
Race/Ethnicity, Customized
Other
34 Participants64 Participants30 Participants
Race/Ethnicity, Customized
White
221 Participants434 Participants213 Participants
Sex: Female, Male
Female
160 Participants321 Participants161 Participants
Sex: Female, Male
Male
95 Participants177 Participants82 Participants
Surgery Duration5.7 hours
STANDARD_DEVIATION 2.5
5.7 hours
STANDARD_DEVIATION 2.5
5.6 hours
STANDARD_DEVIATION 2.5
Type of Surgery
Bariatric
0 Participants1 Participants1 Participants
Type of Surgery
Colorectal
171 Participants338 Participants167 Participants
Type of Surgery
Gynecologica
55 Participants97 Participants42 Participants
Type of Surgery
Other
27 Participants55 Participants28 Participants
Type of Surgery
Urological
2 Participants7 Participants5 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2550 / 243
other
Total, other adverse events
0 / 2550 / 243
serious
Total, serious adverse events
0 / 2550 / 243

Outcome results

Primary

Total Opioid Consumption

Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.

Time frame: During the 72 hours after discharge from the PACU.

Population: Two patients had missing outcomes due to the cancellation of surgery in Epidural analgesia with Bupivacaine group.

ArmMeasureValue (MEDIAN)
TAP Block With ExparelTotal Opioid Consumption56 mg
Epidural Analgesia With BupivacaineTotal Opioid Consumption35 mg
p-value: 0.75495.2% CI: [1.05, 1.79]Mixed Models Analysis
Primary

VRS Pain Score

Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours

Time frame: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.

Population: Two patients had missing outcomes due to the cancellation of surgery in Epidural analgesia with Bupivacaine group.

ArmMeasureValue (MEAN)Dispersion
TAP Block With ExparelVRS Pain Score4.3 score on a scaleStandard Deviation 1.8
Epidural Analgesia With BupivacaineVRS Pain Score4.2 score on a scaleStandard Deviation 1.8
p-value: <0.00195.2% CI: [-0.12, 0.3]Mixed Models Analysis
Secondary

Cumulative Duration of Activity

defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.

Time frame: During the initial 72 postoperative hours.

ArmMeasureValue (MEDIAN)
TAP Block With ExparelCumulative Duration of Activity1.1 hours
Epidural Analgesia With BupivacaineCumulative Duration of Activity1.0 hours
p-value: 0.5699% CI: [0.53, 2.76]Regression, Linear
Secondary

Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.

Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP \<65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 72 postoperative hours.

Time frame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.

ArmMeasureValue (MEAN)Dispersion
TAP Block With ExparelHemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.41 mmHgStandard Deviation 31
Epidural Analgesia With BupivacaineHemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.57 mmHgStandard Deviation 48
p-value: 0.00699% CI: [0.42, 0.98]generalized linear regression
Secondary

Length of Hospital Stay

The length of hospital stay will be measured as days.

Time frame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks

ArmMeasureValue (MEDIAN)
TAP Block With ExparelLength of Hospital Stay4.0 days
Epidural Analgesia With BupivacaineLength of Hospital Stay4.0 days
p-value: 0.73899% CI: [0.86, 1.12]Regression, Linear
Secondary

Opioid-related Side Effect

We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.

Time frame: The first, second and third postoperative mornings

ArmMeasureGroupValue (MEDIAN)
TAP Block With ExparelOpioid-related Side EffectPOD 15.8 score on a scale
TAP Block With ExparelOpioid-related Side EffectPOD 24.9 score on a scale
TAP Block With ExparelOpioid-related Side EffectPOD 33.8 score on a scale
Epidural Analgesia With BupivacaineOpioid-related Side EffectPOD 33.7 score on a scale
Epidural Analgesia With BupivacaineOpioid-related Side EffectPOD 15.5 score on a scale
Epidural Analgesia With BupivacaineOpioid-related Side EffectPOD 24.5 score on a scale
p-value: 0.35799% CI: [-0.65, 1.37]Regression, Linear
Secondary

Quality of Recovery After Anesthesia

Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = none of the time \[poor\] to 10 = all of the time \[excellent\]; Conversely, for negative items, 10 = none of the time \[excellent\] to 0 = all of the time \[poor\]. Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).

Time frame: The first and third postoperative mornings

ArmMeasureGroupValue (MEAN)Dispersion
TAP Block With ExparelQuality of Recovery After AnesthesiaPOD 1102 score on a scaleStandard Deviation 26
TAP Block With ExparelQuality of Recovery After AnesthesiaPOD 3111 score on a scaleStandard Deviation 23
Epidural Analgesia With BupivacaineQuality of Recovery After AnesthesiaPOD 1100 score on a scaleStandard Deviation 24
Epidural Analgesia With BupivacaineQuality of Recovery After AnesthesiaPOD 3111 score on a scaleStandard Deviation 22
p-value: 0.69599% CI: [-4.31, 5.85]Regression, Linear
Other Pre-specified

Duration of Hypoxemia

ViSi mobile (Sotera Wireless) patient monitoring system will be used to obtain vital signs including SpO2 of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. The outcome is area-under-the-curve for saturation over time with the threshold set at 90%.

Time frame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.

ArmMeasureValue (MEDIAN)
TAP Block With ExparelDuration of Hypoxemia1.4 min/h
Epidural Analgesia With BupivacaineDuration of Hypoxemia2.8 min/h
Other Pre-specified

Persistent Postoperative Incisional Pain- MBPI Pain Intensity

Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = no pain and 10 = pain as bad as you can imagine.; and for interference items, 0 = does not interfere and 10 = interferes completely. The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).

Time frame: At the 90-day follow up

ArmMeasureValue (MEDIAN)
TAP Block With ExparelPersistent Postoperative Incisional Pain- MBPI Pain Intensity8 score on a scale
Epidural Analgesia With BupivacainePersistent Postoperative Incisional Pain- MBPI Pain Intensity12 score on a scale
Other Pre-specified

Persistent Postoperative Incisional Pain- MBPI Pain Interference

Defined by the presence of pain at three months and its characteristics as determined by Modified Brief Pain Inventory (MBPI) questionnaires. The modified BPI contains 4 intensity items and 5 interference items with 0-to-10 numerical rating scales. For intensity items: 0 = no pain and 10 = pain as bad as you can imagine.; and for interference items, 0 = does not interfere and 10 = interferes completely. The pain intensity is the sum of the patient's worst, average, least, and current pain intensity, with a score ranging from 0 (no pain) to 40 (pain as bad as you can imagine); and pain Interference is the sum of walking ability, mood, sleep, relations with others, and ability to concentrate, with a score ranging from 0 (does not interfere) to 50 (interferes completely).

Time frame: At the 90-day follow up

ArmMeasureValue (MEDIAN)
TAP Block With ExparelPersistent Postoperative Incisional Pain- MBPI Pain Interference14 score on a scale
Epidural Analgesia With BupivacainePersistent Postoperative Incisional Pain- MBPI Pain Interference17 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026