ObesityNCT04787367
Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter
A study testing TAP block in people with Obesity and Pain, Postoperative, run by Arthur Carlin at 1 site in United States.
Trial summary
The goal of this study is to investigate whether an early intraoperative transverse abdominis plane block (TAP block) will provide superior analgesia to a late intraoperative TAP block. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Pain, Postoperative
- What is being tested?
- TAP block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 1 Jul 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing laparoscopic sleeve gastrectomy
Who cannot join
- Conversion to open procedure
- Prior history of narcotic use (which will be defined as any narcotics used on a recreational basis or any narcotic used for pain relief without having had recent operation or injury)
- Current narcotic use at time of surgery
- Prolonged case time defined as >1 standard deviation over average time
Trial locations and contacts
1 site in 1 country.
United States1 site
Henry Ford Macomb Hospital
Clinton Township, Michigan, 48038
About this study
The goal of this study is to investigate whether an early intraoperative transverse abdominis plane block (TAP block) will provide superior analgesia to a late intraoperative TAP block. A fixed amount of bupivacaine will be used for the TAP block and the primary outcomes will be measured by patient reported numerical assessment scores for pain.
Read the detailed description
This is a single blinded, prospective study designed to determine optimal timing of transverse abdominis plane block (TAP block) in laparoscopic gastric sleeve patients. Research has shown that administration of TAP block during these cases does show improved post-operative pain control. There are no trials specifically evaluating the timing of administration in regards to superiority of pain control. To the investigators knowledge, no prospective study has ever been done investigating whether TAP block performed at the beginning of the case versus at the end of the case makes a difference in the amount of relief experienced by the patient. the investigators hypothesize that early intra-operative block will be superior to late intra-operative block in both post-operative pain as well as decreased length of stay in hospital secondary to reduction in peripheral and central nervous system hyper excitability. Before beginning the research study, ~200 plain envelopes will be made each containing one option written on paper indicating early intra-operative or late intra-operative TAP block. There will be equal numbers of both options. It will be the responsibility of either the PI or sub-investigators to select a random envelope and bring it to the operating room at the time of surgery. All patients involved in the study will have given informed consent in the office prior to surgery. On the day of surgery after the patient is induced and intubated, the PI or sub-investigator will open the envelope revealing the timing of the TAP block. Depending on what is revealed from the envelope, the patient will either receive the early intra-operative TAP block or the late intra-operative TAP block. The TAP block will be performed using 60 ml for right sided TAP block (side of specimen extraction) and 30 ml for left sided TAP block (non extraction side). 30 ml of bupivicaine solution will also be used for intraperitoneal irrigation as is already routinely done during these cases by the primary surgeon for additional analgesia. This will be performed at the conclusion of all cases regardless of which arm the patient is in. For the early intra-operative TAP block, optiview trocar entrance will be performed in the upper abdomen followed by CO2 insufflation. After introduction of the camera into this trocar, the right lateral abdominal wall will be visualized with the laparoscope. An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine. The late post-operative block will be performed in the same fashion but after completion of the surgery just prior to removing the trocars and desufflation. The intraperitoneal irrigation with 0.25% bupivicaine solution will be performed at the end of the case using 30 ml total sprayed above the stomach, under the diaphragm, and over the bed of the spleen. All other medications intra-op and post-op including anesthesia will remain standardized according to the current HF Macomb bariatrics protocols. The data collection will take place immediately post-op, 4, 8, 12, 16, 20, and 24 hours post-op using the numerical assessment score (NAS) for pain which will be performed at the time vitals are taken by the nursing aids. The investigators will also be analyzing post-operative vomiting and length of stay in hours.
- Conditions
- Obesity, Pain, Postoperative
- Being tested
- TAP block
- Keywords
- TAP block, Obesity, Sleeve gastrectomy, Bariatrics, Post-operative pain
- Medical subject headings
- Obesity, 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
An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine.
| Study group | Role | What they receive |
|---|---|---|
| Early-operative TAP block | Experimental | The TAP block will be administered after the placement of the camera port. Receives: Procedure: TAP block |
| Late-operative TAP block | Experimental | The TAP block will be administered at the completion of the case just before removing the camera port. Receives: Procedure: TAP block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores Between Early and Late Groups
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
Measured: Post-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours
Secondary outcomes (1)
Analgesic Utilization in Early and Late Groups
Amount of opioid medication given to the patients.
Measured: PACU until time of discharge up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start12 Feb 2019
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
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.
- Other trials for ObesityStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single blinded, prospective study designed to determine optimal timing of TAP block in laparoscopic gastric sleeve patients. Patients will randomly be assigned to the early intra-operative TAP block group or the late intra-operative TAP block group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arthur Carlin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Arthur Carlin, Henry Ford Health System
- Investigators
- Arthur Carlin, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787367
- Sponsor's protocol ID
- 643256
- Status last verified
- Jun 2026
- First submitted
- 8 May 2018
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter
- ClinicalTrials.gov ID
- NCT04787367
- Acronym / sponsor ID
- 643256
- Conditions
- Obesity, Pain, Postoperative
- Keywords
- TAP block, Obesity, Sleeve gastrectomy, Bariatrics, Post-operative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Arthur CarlinUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 8 Mar 2021 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to investigate whether an early intraoperative transverse abdominis plane block (TAP block) will provide superior analgesia to a late intraoperative TAP block. A fixed amount of bupivacaine will be used for the TAP block and the primary outcomes will be measured by patient reported numerical assessment scores for pain.
Detailed description
This is a single blinded, prospective study designed to determine optimal timing of transverse abdominis plane block (TAP block) in laparoscopic gastric sleeve patients. Research has shown that administration of TAP block during these cases does show improved post-operative pain control. There are no trials specifically evaluating the timing of administration in regards to superiority of pain control. To the investigators knowledge, no prospective study has ever been done investigating whether TAP block performed at the beginning of the case versus at the end of the case makes a difference in the amount of relief experienced by the patient. the investigators hypothesize that early intra-operative block will be superior to late intra-operative block in both post-operative pain as well as decreased length of stay in hospital secondary to reduction in peripheral and central nervous system hyper excitability. Before beginning the research study, ~200 plain envelopes will be made each containing one option written on paper indicating early intra-operative or late intra-operative TAP block. There will be equal numbers of both options. It will be the responsibility of either the PI or sub-investigators to select a random envelope and bring it to the operating room at the time of surgery. All patients involved in the study will have given informed consent in the office prior to surgery. On the day of surgery after the patient is induced and intubated, the PI or sub-investigator will open the envelope revealing the timing of the TAP block. Depending on what is revealed from the envelope, the patient will either receive the early intra-operative TAP block or the late intra-operative TAP block. The TAP block will be performed using 60 ml for right sided TAP block (side of specimen extraction) and 30 ml for left sided TAP block (non extraction side). 30 ml of bupivicaine solution will also be used for intraperitoneal irrigation as is already routinely done during these cases by the primary surgeon for additional analgesia. This will be performed at the conclusion of all cases regardless of which arm the patient is in. For the early intra-operative TAP block, optiview trocar entrance will be performed in the upper abdomen followed by CO2 insufflation. After introduction of the camera into this trocar, the right lateral abdominal wall will be visualized with the laparoscope. An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine. The late post-operative block will be performed in the same fashion but after completion of the surgery just prior to removing the trocars and desufflation. The intraperitoneal irrigation with 0.25% bupivicaine solution will be performed at the end of the case using 30 ml total sprayed above the stomach, under the diaphragm, and over the bed of the spleen. All other medications intra-op and post-op including anesthesia will remain standardized according to the current HF Macomb bariatrics protocols. The data collection will take place immediately post-op, 4, 8, 12, 16, 20, and 24 hours post-op using the numerical assessment score (NAS) for pain which will be performed at the time vitals are taken by the nursing aids. The investigators will also be analyzing post-operative vomiting and length of stay in hours.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single blinded, prospective study designed to determine optimal timing of TAP block in laparoscopic gastric sleeve patients. Patients will randomly be assigned to the early intra-operative TAP block group or the late intra-operative TAP block group.
| Arm | Type | Receives |
|---|---|---|
| Early-operative TAP block | Experimental | Procedure: TAP blockThe TAP block will be administered after the placement of the camera port. |
| Late-operative TAP block | Experimental | Procedure: TAP blockThe TAP block will be administered at the completion of the case just before removing the camera port. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing laparoscopic sleeve gastrectomy
Key exclusion criteria (4 listed)
- Conversion to open procedure
- Prior history of narcotic use (which will be defined as any narcotics used on a recreational basis or any narcotic used for pain relief without having had recent operation or injury)
- Current narcotic use at time of surgery
- Prolonged case time defined as >1 standard deviation over average time
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 blockAn 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a "pop," after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine. | Procedure or surgery | Early-operative TAP block, Late-operative TAP block |
Primary outcome
Pain Scores Between Early and Late Groups
Time frame: Post-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hours
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome).
1 secondary outcome
Analgesic Utilization in Early and Late Groups
Time frame: PACU until time of discharge up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Arthur Carlin, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block in people with Obesity and Pain, Postoperative, run by Arthur Carlin 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 1 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 2 Jul 2026. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). 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?
Pain Scores Between Early and Late Groups (time frame: Post-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 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 2 Jul 2026.