Anesthesia, LocalNCT06274307
Efficacy of Transversus Abdominis Plane Block
A study testing Transversus abdominis plane block in people with Anesthesia, Local, run by Justin Hruska at 2 sites in United States.
Trial summary
This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Local
- What is being tested?
- Transversus abdominis plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Jun 2023to 1 Mar 2025
- Phase
- Interventional
- 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 85 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure.
- Consent received to receive a TAP block.
Who cannot join
- Patients who are not proficient in the English language or cannot consent
- Patients who have an allergy to local anesthetics (amides)
- Patients with subcutaneous emphysema
- Patients whose surgical procedures require incisions above the umbilicus
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Detroit Medical Center Detroit Receiving Hospital
Detroit, Michigan, 48201
Detroit Medical Center, Harper University Hospital
Detroit, Michigan, 48201
About this study
Official title: Efficacy of Transversus Abdominis Plane Block in an Insufflated Abdomen
This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method.
Read the detailed description
Background
Every year 15 million laparoscopic procedures are performed globally, with 4,800,000 or 32% of procedures performed in the U.S. alone. This minimally invasive procedure is one of the most common surgical procedures in the United States. Approximately 350,000 or half of all bilateral tubal sterilizations are performed laparoscopically; almost two-thirds of the 600,000 hysterectomies are performed via laparoscopy. Laparoscopy is also commonly used for diagnostic purposes, and to perform other common procedures such as treatment for endometriosis and lysis of adhesions. During laparoscopic gynecologic surgeries, the surgical team will have the abdomen inflated with pressurized carbon dioxide for surgical visualization purposes which is then released at the end of the surgical procedure. For many laparoscopic procedures, a transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain performed outside the OR, more for logistical ease, traditionally this block is performed outside the operating room setting, in the post-operative period on a non- insufflated abdomen under ultrasound guidance.
Rationale for conducting the research. This study has two major aims; 1) to determine whether post-operative TAP blocks performed in an insufflated abdomen will result in more optimal postoperative pain control compared to TAP blocks performed in the traditional method in a non-insufflated abdomen and 2) to observe if performing the TAP block in a insufflated abdomen will be more clinically efficient to perform than the traditional method performed in a non-insufflated abdomen. The study hypothesis is that the study group receiving the TAP block the insufflated abdomen will have more optimal postoperative pain control, requiring less adjuvant pain medication as compared to the participants receiving the control intervention. Additionally, we hypothesize that the proceduralist will be able to perform a TAP block in less time with and with few attempts in the insufflated compared to the non- insufflated abdomen group due to better visualization of the anatomical planes from insufflation of the abdominal area. The results of this study may add additional clinically effective practice guidelines for both regional anesthesia and acute pain management relating to laparoscopic gynecological procedures. Furthermore, TAP blocks performed under insufflation may provide a viable method for decreasing opioid use and reducing potential opioid dependence in patients following surgical intervention.
- Conditions
- Anesthesia, Local
- Being tested
- Transversus abdominis plane block
- Keywords
- Transversus abdominal-plane block, Pain managment, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus abdominis plane blockProcedure or surgery
A transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain during the intermediate (12-24hr) post-operative period following laparoscopic abdominal surgeries. Drug: The local anesthetic to be used in this specific intervention will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% and divided equally bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Transversus abdominis plane (TAP) block performed in operating room | Active comparator | The treatment group will have a transversus abdominis plane (TAP) block performed prior to closing surgical port sites post-operatively in an insufflated abdomen in the operating room (OR). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses. Receives: Procedure: Transversus abdominis plane block |
| Transversus abdominis plane (TAP) block performed in PACU | Active comparator | The treatment group will have a transversus abdominis plane (TAP) block performed post-operatively after the patient has been transferred from the Operating Room to the Post Anesthesia Care Unit (PACU). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses Receives: Procedure: Transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to perform TAP Block
Time taken to successfully perform the TAP block. Defined as the time from initial placement of ultrasound probe on the skin to the completion of the block on the contralateral side.
Measured: Within 10 minutes of starting procedure.
TAP block attempts
The number of attempts taken to sucessfully perform the TAP block.
Measured: Within 10 minutes of starting procedure.
Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Measured: 0 hours following TAP block]
Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Measured: 1 hour following TAP block]
Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Measured: 2 hours following TAP block]
Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Measured: 4 hours following TAP block]
Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Measured: 24 hours following TAP block]
Postoperative Opioid Consumption
Patient opioid consumption in the 24 hours post TAP block
Measured: 24 hours post operative period
Ease of performing TAP Block-anatomical plane visualization
The anatomical planes were clearly visualized and identified. Survey of operator - Likert Score
Measured: Within 10 minutes of starting procedure
Ease of performing TAP Block-performance efficacy
The approach optimized the efficacy of the block. Survey of operator- Likert score
Measured: Within 10 minutes of starting procedure
Patient satisfaction
Patient satisfaction with analgesia score (0 to 100%)
Measured: 24-hours post operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start22 Jun 2023
- Primary completion1 Jan 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Hruska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Justin Hruska, Wayne State University
- Investigators
- Justin Hruska, MD, Principal investigator, Wayne State University/Detroit Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274307
- Sponsor's protocol ID
- IRB-21-10-4045
- Status last verified
- Mar 2025
- First submitted
- 13 Feb 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transversus Abdominis Plane Block in an Insufflated Abdomen
- ClinicalTrials.gov ID
- NCT06274307
- Acronym / sponsor ID
- IRB-21-10-4045
- Conditions
- Anesthesia, Local
- Keywords
- Transversus abdominal-plane block, Pain managment, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Justin HruskaUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 23 Feb 2024 (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.
This study aims to assess the efficacy of Transversus Abdominus Plane (TAP) blocks, a well-established anesthetic technique, to decrease the amount of post-operative pain in patients who undergo minimally invasive gynecologic surgeries. During minimally invasive gynecologic surgeries, the abdomen is inflated with pressurized air for visualization purposes and released at the end of the surgery. Traditionally, TAP blocks are performed by injecting long-acting local anesthetic agents under ultrasound guidance into the abdominal wall after abdominal surgery after the air has been emptied from the abdomen for additional anesthetic coverage post-operatively. This study proposes a novel approach: that performing TAP blocks while the abdomen is still insufflated will result in better post-operative pain outcomes as compared to the traditional method.
Detailed description
Background
Every year 15 million laparoscopic procedures are performed globally, with 4,800,000 or 32% of procedures performed in the U.S. alone. This minimally invasive procedure is one of the most common surgical procedures in the United States. Approximately 350,000 or half of all bilateral tubal sterilizations are performed laparoscopically; almost two-thirds of the 600,000 hysterectomies are performed via laparoscopy. Laparoscopy is also commonly used for diagnostic purposes, and to perform other common procedures such as treatment for endometriosis and lysis of adhesions. During laparoscopic gynecologic surgeries, the surgical team will have the abdomen inflated with pressurized carbon dioxide for surgical visualization purposes which is then released at the end of the surgical procedure. For many laparoscopic procedures, a transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain performed outside the OR, more for logistical ease, traditionally this block is performed outside the operating room setting, in the post-operative period on a non- insufflated abdomen under ultrasound guidance.
Rationale for conducting the research. This study has two major aims; 1) to determine whether post-operative TAP blocks performed in an insufflated abdomen will result in more optimal postoperative pain control compared to TAP blocks performed in the traditional method in a non-insufflated abdomen and 2) to observe if performing the TAP block in a insufflated abdomen will be more clinically efficient to perform than the traditional method performed in a non-insufflated abdomen. The study hypothesis is that the study group receiving the TAP block the insufflated abdomen will have more optimal postoperative pain control, requiring less adjuvant pain medication as compared to the participants receiving the control intervention. Additionally, we hypothesize that the proceduralist will be able to perform a TAP block in less time with and with few attempts in the insufflated compared to the non- insufflated abdomen group due to better visualization of the anatomical planes from insufflation of the abdominal area. The results of this study may add additional clinically effective practice guidelines for both regional anesthesia and acute pain management relating to laparoscopic gynecological procedures. Furthermore, TAP blocks performed under insufflation may provide a viable method for decreasing opioid use and reducing potential opioid dependence in patients following surgical intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group (Group 1) will have a transversus abdominis plane (TAP) block performed with an insufflated abdomen in the operating room. The control group (Group 2) will receive the traditionally performed standard of care TAP block performed in the post-anesthesia care unit
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Transversus abdominis plane (TAP) block performed in operating room | Active comparator | Procedure: Transversus abdominis plane blockThe treatment group will have a transversus abdominis plane (TAP) block performed prior to closing surgical port sites post-operatively in an insufflated abdomen in the operating room (OR). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses. |
| Transversus abdominis plane (TAP) block performed in PACU | Active comparator | Procedure: Transversus abdominis plane blockThe treatment group will have a transversus abdominis plane (TAP) block performed post-operatively after the patient has been transferred from the Operating Room to the Post Anesthesia Care Unit (PACU). The local anesthetic used for the TAP block will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% divided equally bilaterally. Each study participant will receive standard post-operative pain medication orders of morphine 2mg q5mins times 4 doses followed by hydromorphone. 0.5mg q10mins times 4 doses |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female gynecological patients between 18 years and 85 years consented and scheduled for an obstetrics/gynecology laparoscopic procedure.
- Consent received to receive a TAP block.
Key exclusion criteria (4 listed)
- Patients who are not proficient in the English language or cannot consent
- Patients who have an allergy to local anesthetics (amides)
- Patients with subcutaneous emphysema
- Patients whose surgical procedures require incisions above the umbilicus
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 |
|---|---|---|
| Transversus abdominis plane blockA transversus abdominis plane block (TAP) block using a long-acting local anesthetic is used to manage pain during the intermediate (12-24hr) post-operative period following laparoscopic abdominal surgeries. Drug: The local anesthetic to be used in this specific intervention will be 30 to 40ml of Ropivacaine 0.375%, not to exceed a max dose of 3mg/kg of 0.375% and divided equally bilaterally. | Procedure or surgery | Active Comparator: Transversus abdominis plane (TAP) block performed in operating room, Transversus abdominis plane (TAP) block performed in PACU |
Primary outcome
Time to perform TAP Block
Time frame: Within 10 minutes of starting procedure.
Time taken to successfully perform the TAP block. Defined as the time from initial placement of ultrasound probe on the skin to the completion of the block on the contralateral side.
TAP block attempts
Time frame: Within 10 minutes of starting procedure.
The number of attempts taken to sucessfully perform the TAP block.
Pain Score Visual Analog Scale (VAS) 0 Hours Post Surgery
Time frame: 0 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 1 Hours Post Surgery
Time frame: 1 hour following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 2 Hours Post Surgery
Time frame: 2 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 4 Hours Post Surgery
Time frame: 4 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Pain Score Visual Analog Scale (VAS) 24 Hours Post Surgery
Time frame: 24 hours following TAP block]
Pain score on an 11-point (0 - no pain to 10 - worst imaginable pain) Visual Analog Scale (VAS) at rest
Postoperative Opioid Consumption
Time frame: 24 hours post operative period
Patient opioid consumption in the 24 hours post TAP block
Ease of performing TAP Block-anatomical plane visualization
Time frame: Within 10 minutes of starting procedure
The anatomical planes were clearly visualized and identified. Survey of operator - Likert Score
Ease of performing TAP Block-performance efficacy
Time frame: Within 10 minutes of starting procedure
The approach optimized the efficacy of the block. Survey of operator- Likert score
Patient satisfaction
Time frame: 24-hours post operative period
Patient satisfaction with analgesia score (0 to 100%)
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 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Local
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
RecruitingPhase 3
A Study of Changes to Prostate Procedures
Prostate Cancer
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
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.
Justin Hruska, MD principal investigator
Wayne State University/Detroit Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus abdominis plane block in people with Anesthesia, Local, run by Justin Hruska 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 2 inclusion and 4 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 24 Mar 2025. 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?
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?
Time to perform TAP Block (time frame: Within 10 minutes of starting procedure.). The study lists 11 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 24 Mar 2025.