Pain, PostoperativeNCT02996227
Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
A study testing TAP block, Epidural analgesia and EXPAREL in people with Pain, Postoperative and Major Abdominal Surgery, run by The Cleveland Clinic at 2 sites in United States.
Trial summary
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative, Major Abdominal Surgery
- What is being tested?
- TAP block, Epidural analgesia and EXPAREL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2016to Oct 2019
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
About this study
Official title: Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
Read the 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.
- Conditions
- Pain, Postoperative, Major Abdominal Surgery
- Being tested
- TAP block, Epidural analgesia, EXPAREL, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP blockProcedure or surgery
Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
Epidural analgesiaProcedure or surgery
Epidural catheters will be inserted preoperatively.
EXPARELDrug
Also called Liposomal Bupivacaine
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.
BupivacaineDrug
Also called Marcaine
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.
| Study group | Role | What they receive |
|---|---|---|
| TAP block with Exparel | Experimental | Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel) Receives: Procedure: TAP block; Drug: EXPAREL |
| Epidural analgesia with Bupivacaine | Active comparator | Epidural catheters with an infusion of Bupivacaine standard solution without additives Receives: Procedure: Epidural analgesia; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
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.
Measured: During the 72 hours after discharge from the PACU.
Secondary outcomes (5)
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.
Measured: During the initial 72 postoperative hours.
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.
Measured: The first, second and third postoperative mornings
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.
Measured: Data was recorded at 15-s intervals during the initial 72 postoperative hours.
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).
Measured: The first and third postoperative mornings
Length of Hospital Stay
The length of hospital stay will be measured as days.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2019
- Study completionOct 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 Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alparslan Turan, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996227
- Sponsor's protocol ID
- 16-1449 -EXPLANE Block
- Status last verified
- Jan 2024
- First submitted
- 5 Dec 2016
- Last updated
- 31 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Turan A, Cohen B, Elsharkawy H, Maheshwari K, Soliman LM, Babazade R, Ayad S, Hassan M, Elkassabany N, Essber HA, Kessler H, Mao G, Esa WAS, Sessler DI; EXPLANE Study Group. Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. J Clin Anesth. 2022 May;77:110640. doi: 10.1016/j.jclinane.2021.110640. Epub 2021 Dec 27.
PubMed 34969004
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02996227
- Acronym / sponsor ID
- 16-1449 -EXPLANE Block
- Conditions
- Pain, Postoperative, Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Jun 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Posted 31 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block with Exparel | Experimental | Procedure: TAP block, Drug: EXPARELBilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel) |
| Epidural analgesia with Bupivacaine | Active comparator | Procedure: Epidural analgesia, Drug: BupivacaineEpidural catheters with an infusion of Bupivacaine standard solution without additives |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| TAP blockTransversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure. | Procedure or surgery | TAP block with Exparel |
| Epidural analgesiaEpidural catheters will be inserted preoperatively. | Procedure or surgery | Epidural analgesia with Bupivacaine |
| EXPARELAlso: Liposomal BupivacaineOnce 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. | Drug | TAP block with Exparel |
| BupivacaineAlso: MarcaineOnce 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. | Drug | Epidural analgesia with Bupivacaine |
Primary outcome
VRS Pain Score
Time frame: The 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
Total Opioid Consumption
Time frame: During 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.
5 secondary outcomes
Cumulative Duration of Activity
Time frame: During the initial 72 postoperative hours.
Opioid-related Side Effect
Time frame: The first, second and third postoperative mornings
Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.
Time frame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.
Quality of Recovery After Anesthesia
Time frame: The first and third postoperative mornings
Length of Hospital Stay
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34969004Turan A, Cohen B, Elsharkawy H, Maheshwari K, Soliman LM, Babazade R, Ayad S, Hassan M, Elkassabany N, Essber HA, Kessler H, Mao G, Esa WAS, Sessler DI; EXPLANE Study Group. Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. J Clin Anesth. 2022 May;77:110640. doi: 10.1016/j.jclinane.2021.110640. Epub 2021 Dec 27.
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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.
Alparslan Turan, MD principal investigator
The Cleveland Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block, Epidural analgesia and EXPAREL in people with Pain, Postoperative and Major Abdominal Surgery, run by The Cleveland Clinic at 2 sites 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 7 inclusion and 6 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 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2024). 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?
VRS Pain Score (time frame: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.). 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 NCT02996227, 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 31 Jan 2024.