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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT04787367
Study groupRoleWhat they receive
Early-operative TAP blockExperimentalThe TAP block will be administered after the placement of the camera port.
Receives: Procedure: TAP block
Late-operative TAP blockExperimentalThe 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.

  1. 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)
  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.

  1. First posted8 Mar 2021
  2. Study start12 Feb 2019
  3. Primary completion1 Jul 2022
  4. Study completion1 Jul 2022

Resources

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)
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
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

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Clinical Trial NCT04787367 | AzTrials