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Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter

Laparoscopic TAP Block for Sleeve Gastrectomy: Does Timing Matter

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04787367
Enrollment
200
Registered
2021-03-08
Start date
2019-02-12
Completion date
2022-07-01
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Pain, Postoperative

Keywords

TAP block, Obesity, Sleeve gastrectomy, Bariatrics, Post-operative pain

Brief 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. 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.

Interventions

PROCEDURETAP block

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.

Sponsors

Arthur Carlin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Masking description

The patient will be unaware of when they received the block. The nursing assistants checking the pain score will also be unaware of the timing of the block.

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Undergoing laparoscopic sleeve gastrectomy

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Pain Scores Between Early and Late GroupsPost-operatively at 0 hours, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, and 24 hoursUsing 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).

Secondary

MeasureTime frameDescription
Analgesic Utilization in Early and Late GroupsPACU until time of discharge up to 30 daysAmount of opioid medication given to the patients.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORArthur Carlin, MD

Henry Ford Hospital

Baseline characteristics

Characteristic
Age, Continuous43.0 years
STANDARD_DEVIATION 13
Arthritis
No
71.0 Participants
Arthritis
Yes
38.0 Participants
BMI46.0 kg/m^2
STANDARD_DEVIATION 7
Degenerative Disc Disease
No
92.0 Participants
Degenerative Disc Disease
Yes
8.0 Participants
Hiatal Hernia Repair
No
162 Participants
Hiatal Hernia Repair
Yes
20.0 Participants
Hyperlipidemia
No
52.0 Participants
Hyperlipidemia
Yes
48.0 Participants
Hypertension
No
101 Participants
Hypertension
Yes
99 Participants
Obstructive Sleep Apnea
No
118 Participants
Obstructive Sleep Apnea
Yes
82 Participants
Race/Ethnicity, Customized
African American
72 Participants
Race/Ethnicity, Customized
Caucasian
61.0 Participants
Race/Ethnicity, Customized
Hispanic
1.0 Participants
Race/Ethnicity, Customized
Other
1.0 Participants
Region of Enrollment
United States
100 participants
Sex/Gender, Customized
Female
89.0 Participants
Sex/Gender, Customized
Male
11.0 Participants
Type II Diabetes
No
136 Participants
Type II Diabetes
Yes
64 Participants
Weight116.9 weight in "kg"
STANDARD_DEVIATION 21

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 100
other
Total, other adverse events
0 / 1000 / 100
serious
Total, serious adverse events
0 / 1000 / 100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 3, 2026