Postoperative PainPhase 1LATAPNCT02400645
TAP Block With Liposomal Bupivacaine Versus Pre-incisional Wound Infiltration With Bupivacaine for Postoperative Pain
A Phase 1 study testing Pre-incisional wound infiltration, Laparoscope to place TAP block with liposomal bupivacaine and Liposomal bupivacaine in people with Postoperative Pain, run by University of Tennessee.
Trial summary
In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Pre-incisional wound infiltration, Laparoscope to place TAP block with liposomal bupivacaine and Liposomal bupivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ASA physical status 1-3,
- Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
- Able to participate personally or by legal representation in informed consent
Who cannot join
- History of relevant allergy to the study drugs (Bupivacaine),
- Chronic opioid use or drug abuse history,
- Inability to understand the study protocol,
- Refusal to provide written consent,
- Soft tissue infection of the abdominal wall and skin
About this study
Official title: Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy
In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.
Read the detailed description
Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit.
Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated.
Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.
- Conditions
- Postoperative Pain
- Being tested
- Pre-incisional wound infiltration, Laparoscope to place TAP block with liposomal bupivacaine, Liposomal bupivacaine, Bupivacaine, Ketorolac
- Keywords
- laparoscopic hysterectomy, robotic assisted hysterectomy
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-incisional wound infiltrationProcedure or surgery
Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
Laparoscope to place TAP block with liposomal bupivacaineProcedure or surgery
Also called Laparoscopic TAP block with Liposomal bupivacaine
Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%
Liposomal bupivacaineDrug
Also called Exparel
Use of Liposomal bupivacaine in laparoscopic TAP block
BupivacaineDrug
Also called Marcaine
20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
KetorolacDrug
Also called Toradol
Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
| Study group | Role | What they receive |
|---|---|---|
| Group A: pre-incisional bupivacaine | Active comparator | Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure. Receives: Procedure: Pre-incisional wound infiltration; Drug: Bupivacaine; Drug: Ketorolac |
| Group B: laparoscope to place TAP block | Active comparator | Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure. Receives: Procedure: Laparoscope to place TAP block with liposomal bupivacaine; Drug: Liposomal bupivacaine; Drug: Bupivacaine; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog pain scores (VAS)
- Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS)
- VAS: 0 (no pain) TO 10 (worst possible pain)
Measured: Two hours
Secondary outcomes (2)
Narcotic pain medication usage
Narcotic pain medication usage intraoperative and in recovery assessed as morphine equivalents
Measured: 2 hours postoperative
Narcotic pain medication following surgery
Narcotic pain medication pill counts up to one week postoperatively
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: It was determined that one member of the team had falsified data.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shanti I Mohling, MD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400645
- Sponsor's protocol ID
- 14-132
- Acronym
- LATAP
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Laparoscopically Assisted Transversus Abdominis Plane Block Using Liposomal Bupivacaine With Pre-incisional Bupivacaine for Post-operative Pain Control in Patients Undergoing Laparoscopic or Robotic Hysterectomy
- ClinicalTrials.gov ID
- NCT02400645
- Acronym / sponsor ID
- LATAP / 14-132
- Conditions
- Postoperative Pain
- Keywords
- laparoscopic hysterectomy, robotic assisted hysterectomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: It was determined that one member of the team had falsified data.
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.
Detailed description
Patients undergoing laparoscopic or robotic assisted total hysterectomy at Erlanger Hospital will be randomized into one of two groups to receive either laparoscopic assisted TAP block with liposomal bupivacaine and bupivacaine (Group A) or pre-incisional bupivacaine (Group B). The remaining aspects of the perioperative care, including the general anesthesia care and postoperative care will be similar for all patients. Ideally, patients will be informed and consented for the study in the preoperative clinic setting. They will be randomized in the pre-anesthesia care unit.
Patients in Group A will receive laparoscopic-assisted bilateral TAP blocks using 10cc liposomal bupivacaine, 10cc Bupivacaine 0.25% and 10cc Normal Saline one each side. Patients in Group B will receive a total of 20cc pre-incisional Bupivacaine divided between each of the trocar sites. All patients will receive Ketorolac 30 mg, IV at the conclusion of surgery. All patients will be offered either oral pain medications or patient controlled anesthesia (PCA) opiate pain medication as indicated. Morphine equivalents will be calculated.
Postoperative pain control will be assessed using Visual Analog Pain Score (VAS). This will be done by recovery room personnel who will be blinded as to whether the patients received TAP block or pre-incisional anesthetic. VAS will be assessed at rest at 1 hour and 2 hours after arrival to PACU. Patients will be assessed with Overall Benefit of Anesthesia Score (OBAS) questionnaires at postoperative days 1, 2 and 7. OBAS questionnaires will be done by personnel blinded to anesthesia technique. Patients will also be blinded as to which group they were in. Total morphine equivalents of intraoperative and postoperative pain medications will be calculated through postoperative day 7.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: pre-incisional bupivacaine | Active comparator | Procedure: Pre-incisional wound infiltration, Drug: Bupivacaine, Drug: KetorolacIntervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure. |
| Group B: laparoscope to place TAP block | Active comparator | Procedure: Laparoscope to place TAP block with liposomal bupivacaine, Drug: Liposomal bupivacaine, Drug: Bupivacaine, Drug: KetorolacIntervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status 1-3,
- Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
- Able to participate personally or by legal representation in informed consent
Key exclusion criteria (5 listed)
- History of relevant allergy to the study drugs (Bupivacaine),
- Chronic opioid use or drug abuse history,
- Inability to understand the study protocol,
- Refusal to provide written consent,
- Soft tissue infection of the abdominal wall and skin
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 |
|---|---|---|
| Pre-incisional wound infiltrationIntraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions | Procedure or surgery | Group A: pre-incisional bupivacaine |
| Laparoscope to place TAP block with liposomal bupivacaineAlso: Laparoscopic TAP block with Liposomal bupivacaineIntraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25% | Procedure or surgery | Group B: laparoscope to place TAP block |
| Liposomal bupivacaineAlso: ExparelUse of Liposomal bupivacaine in laparoscopic TAP block | Drug | Group B: laparoscope to place TAP block |
| BupivacaineAlso: Marcaine20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution. | Drug | Group A: pre-incisional bupivacaine, Group B: laparoscope to place TAP block |
| KetorolacAlso: ToradolKetorolac 30mg to be given IV at end of surgical procedure unless contraindicated. | Drug | Group A: pre-incisional bupivacaine, Group B: laparoscope to place TAP block |
Primary outcome
Visual Analog pain scores (VAS)
Time frame: Two hours
1. Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) 2. VAS: 0 (no pain) TO 10 (worst possible pain)
2 secondary outcomes
Narcotic pain medication usage
Time frame: 2 hours postoperative
Narcotic pain medication following surgery
Time frame: 1 week
Results and safety
The study was stopped early (reason given: It was determined that one member of the team had falsified data.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
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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.
Shanti I Mohling, MD principal investigator
University of Tennessee
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pre-incisional wound infiltration, Laparoscope to place TAP block with liposomal bupivacaine and Liposomal bupivacaine in people with Postoperative Pain, run by University of Tennessee.
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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: It was determined that one member of the team had falsified data.). Results are not available in the source record.
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?
Visual Analog pain scores (VAS) (time frame: Two hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.