the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology SurgeriesPhase 2TAPNCT04345341
Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block Compared to Ultrasound-guided TAP Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
A Phase 2 study testing TAP block with liposomal bupivacaine and bupivacaine in people with the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries, run by Yale University at 1 site in United States.
Trial summary
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
- What is being tested?
- TAP block with liposomal bupivacaine and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 15 Oct 2023
- Phase
- Phase 2
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients 18 years old and above
- English speaking
- patients with capacity to consent
- Elective laparoscopic and robotic benign genecology cases
- Elective laparoscopy/ robotic hysterectomy
- Elective laparoscopy/robotic myomectomy
- ERAS (enhanced recovery after surgery) protocol applied
Who cannot join
- Pregnant women
- patients with positive urine pregnancy test in pre operative
- emergency procedures
- Procedure requiring staging or debulking
- surgeries that convert to laparotomy
- patients with allergy to local/systemic anaesthesia or analgesia
Show all 16Show fewer
- Inability to undergo normal anesthesia induction process
- ASA III or higher
- history of pain relief medication dependence
- history of substance abuse
- end stage chronic kidney disease
- advanced liver disease
- history of chronic pain
- history of taking opioids or neuropathic agents regularly prior to surgery
- BMI of 50 or over
- skin infections at the site of TAP block injection or port sites.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group.
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Read the detailed description
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .
- Conditions
- the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
- Being tested
- TAP block with liposomal bupivacaine and bupivacaine
- Keywords
- TAP block , laparoscopy , minimally invasive gynecology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block with liposomal bupivacaine and bupivacaineDrug
injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic assisted TAP block | Active comparator | Laparoscopic assisted TAP block will be done by surgeon intra-operatively Receives: Drug: TAP block with liposomal bupivacaine and bupivacaine |
| no TAP block | No intervention | no TAP block would be done |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scores at 24 hours in LA-TAP and NO TAP block groups
numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours.
Measured: 24 hour post op
Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively
MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time.
Measured: 24 hour post op
Secondary outcomes (3)
Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups
numeric pain score (NPS)
Measured: 48 -72 hour post operative
amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ?
morphine equivalent dose of narcotic use
Measured: 48 -72 hours post operative
Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op
nausea and vomiting, yes or no .
Measured: first 72 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start1 Nov 2020
- Primary completion15 Oct 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology SurgeriesStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Farinaz Seifi, MD, FACOG, Principal investigator, Yale University Obstetrics, Gynecology & Reproductive Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04345341
- Sponsor's protocol ID
- 2000026422
- Other IDs
- No NIH funding
- Acronym
- TAP
- Status last verified
- Nov 2023
- First submitted
- 1 Apr 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Laparoscopic-assisted Transversus Abdominus Plane (TAP) Block in Minimally Invasive Gynecologic Surgeries: A Prospective, Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT04345341
- Acronym / sponsor ID
- TAP / 2000026422
- Conditions
- the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries
- Keywords
- TAP block , laparoscopy , minimally invasive gynecology
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 14 Apr 2020 (actual)
- 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.
We propose a clinical trial to determine the efficacy of Laparoscopic Transversus Abdominis Plane (LA-TAP) performed intraoperatively compared with usual postoperative analgesia without LA-TAP block. We hypothesise that there will be a decrease in postoperative opioid utilization and in pain scores for patients randomized to receive the LA-TAP block verses those who do not. We expect that patients will opt to take less break through opioid medication in the LA-TAP block group versus the no TAP block group.
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Detailed description
Investigators aim to answer the above questions through the following primary and secondary outcomes:
Primary outcomes Is there a difference in pain scores reported by the patient at 24 hours following LA-TAP versus no TAP block? Is there a clinically significant difference in cumulative postoperative opioid consumption, expressed as milligram morphine equivalents (MMEs) at 24 hours following LA-TAP blocks versus no TAP block? Secondary outcomes Is there a difference between study groups in pain scores at 48 \& 72 hours? Is there a difference between study groups in total opioid consumption (MMEs) by 48 \& 72 hours? Is there a difference between the study groups for reported post-operative nausea and vomiting? Is there a difference between the study groups in operating time? Is there a difference between the study groups in the length of Hospital stay? Is there a difference between the study groups in patient's satisfaction?
Patients will be randomized in two arms , LA-TAP , NO-TAP block . Each patient would fill out the pain score sheet and number of narcotic medications she used in first 24h, 48h and 72 h post operatively .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic assisted TAP block | Active comparator | Drug: TAP block with liposomal bupivacaine and bupivacaineLaparoscopic assisted TAP block will be done by surgeon intra-operatively |
| no TAP block | No intervention | –no TAP block would be done |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients 18 years old and above
- English speaking
- patients with capacity to consent
- Elective laparoscopic and robotic benign genecology cases
- Elective laparoscopy/ robotic hysterectomy
Key exclusion criteria (16 listed)
- Pregnant women
- patients with positive urine pregnancy test in pre operative
- emergency procedures
- Procedure requiring staging or debulking
- surgeries that convert to laparotomy
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 block with liposomal bupivacaine and bupivacaineinjecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves | Drug | Laparoscopic assisted TAP block |
Primary outcome
pain scores at 24 hours in LA-TAP and NO TAP block groups
Time frame: 24 hour post op
numeric pain score (NPS)pain scores at 24 hours will include the average pain score at rest reported by the patient in the first 24 hours.
Amount and type of opioid consumption , based on Questionnaire's information . between LA-TAP , UG-TAP and No TAP groups at 24 hours post operatively
Time frame: 24 hour post op
MME will be calculated as the cumulative amount of opioid intake in the 24 hours following anesthesia end time.
3 secondary outcomes
Numeric pain score (NPS) based on questionnaire's information at 48 hours & 72 hours post operatively , in LA-TAP , UG-TAp and no TAP groups
Time frame: 48 -72 hour post operative
amount of narcotic , per milligram and type of opiod consumption at 48 & 72 hours post operatively ?
Time frame: 48 -72 hours post operative
Nausea and vomiting post operatively , based on questionnaire's information at first 72 h post op
Time frame: first 72 hours post operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
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.
Farinaz Seifi, MD, FACOG principal investigator
Yale University Obstetrics, Gynecology & Reproductive Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAP block with liposomal bupivacaine and bupivacaine in people with the Efficacy of Analgesia of Laparoscopic TAP Block in Minimally Invasive Gynecology Surgeries, run by Yale University at 1 site 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 16 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
pain scores at 24 hours in LA-TAP and NO TAP block groups (time frame: 24 hour post op). 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?
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 18 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.