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CompletedNCT01308554Updated Mar 26, 2014

Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.

A Phase 4 interventional study of Placebo: sterile normal saline and Marcaine in Pain, Obesity and Surgery, sponsored by Funch-Jensen, Peter, M.D., D.M.Sc.. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-03-26.

Sponsored by Funch-Jensen, Peter, M.D., D.M.Sc. · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to determine whether injection of bupivacaine into the TAP is effective in the treatment of post operative pain after laparoscopic gastric bypass

Read the detailed description

Obesity surgery is expensive, although highly competitive to the cost of obesity related disease. An important step would be to reorganize obesity surgery into a day surgical procedure. Some reports already exist in the literature but the number of publications are sparse, and the description of the condition of the patient is limited. Our primary aim, therefore, is to investigate the influence transverses abdominis plane block has on pain after laparoscopic gastric bypass.

The benefits of adequate postoperative analgesia are clear, and include a reduction in the postoperative stress response, reduction in postoperative morbidity and in certain types of surgery, improved surgical outcome. The benefits of utilizing regional analgesic techniques compared to systemic analgesics include reduction in pain intensity, decreased incidence of side effects from systemic analgesics and improved patient comfort. Effective pain control thereby accelerates recovery from surgery.

A substantial component of the pain experienced by patients after abdominal surgery is derived from the abdominal wall incision.

The Transversus Abdominis Plane (TAP) Block was first described in 2001 in a letter by Dr. Rafi. McDonnell et al have developed and tested the block and describes it as a landmark technique. TAP Block involves blocking the sensory afferent nerves that supply the anterior abdominal wall including the skin, muscles and the parietal peritoneum. Hebbard et al subsequently described an ultrasound guided technique for the TAP block which they named the Posterior TAP block. The posterior TAP block provides analgesia on the lower abdominal wall. Hebbard also described another ultrasound-guided technique called the Oblique Sub costal TAP block which provides analgesia for surgery on the upper abdominal wall.

There is some debate over the extent of sensory blockade achieved by TAP block. Nerves supplying the anterior abdominal wall are derived from T16 to L1 and pass through this plane before supplying the anterior abdominal wall. Earlier studies showed a T7-L1 spread of the block after a single posterior TAP injection, while some newer studies revealed that the block failed to spread above T10 so was suitable only for lower abdominal procedures. In contrast the oblique sub costal TAP block can provide an effective analgesia after surgery that involves dermatome T6 to T10, in other word provide analgesia for surgery on the upper abdominal wall.

Studies looking at posterior TAP block have demonstrated reduced postoperative morphine consumption and improved pain scores at rest and on movement in patients undergoing lower midline laparotomy, open appendectomy, laparoscopic appendectomy total abdominal hysterectomy, caesarean section and laparoscopic cholecystectomy. The duration of the morphine-sparing effect after a single shot injection into the posterior TAP has been reported to range from 12 to 48 hours. Pain scores both in rest and on movement are reduced compared to placebo in up to 48 hours after surgery. Single shot TAP blocks have also been used to provide analgesia in patients admitted to the ICU the analgesia provided by the block lasted between 16 to 24 hours.

There has been a report from Leicester General Hospital of the effectiveness of inserting catheters into the oblique sub costal TAP. The obtained block provided analgesia for more than 72 hours in patients who have had surgery on the upper abdominal wall (hepatobiliary surgery). They also describe the block as being effective rescue analgesia in patients in whom the epidural is ineffective.

Currently there are to our knowledge no clinical trials on the analgesic efficacy of single shot oblique sub costal TAP blocks for surgery of the upper abdominal wall. Niraj et al reports that they have observed the duration of postoperative analgesia to be 6 to 8 hours after single shot sub costal TAP. While Patil et al reports of sensory blockade for 5 hours along the dermatomal level T7-L1 after single shot posterior TAP block combined with sub costal TAP block.

Oblique sub costal TAP block could be a viable alternative for providing analgesia during the postoperative period. The block can be performed easily using ultrasound guidance, has an excellent safety profile, provides effective dynamic analgesia and has a significant morphine-sparing effect.

The proposed study involves the utilization of ultrasound to locate the oblique subcostal TAP, injection of bupivacaine or placebo (saline) into the TAP on each side and comparison of the analgesic efficacy of the TAP injection with that of placebo during two weeks in patients who have had gastric bypass.

02

Conditions studied

  • Pain
  • Obesity
  • Surgery
  • Neuromuscular Inhibition

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Keywords

  • TAP block
  • Pain
  • Obesity
  • Surgery
  • Laparoscopic gastric bypass
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 80 is above the median of 70 across 2,101 interventional studies indexed under Pain.

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Lead sponsor

This is the only study on the registry with Funch-Jensen, Peter, M.D., D.M.Sc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients aged over 18 years who are scheduled for elective gastric bypass (incisions with the lower end of the incision at or above thoracic T 10 dermatome)

Exclusion criteria

Exclusion Criteria:

  • Lack of consent including from those patients who lack mental capacity to give informed consent
  • Patients with history of drug allergy to bupivacaine
  • Patients with history of chronic pain conditions: defined as patients with history of pain for above 3 months and who consume regular analgesics for their chronic pain
  • American Society of Anesthesiologists (ASA) Class 4 and 5
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    Sterile normal saline

    Control group will receive sterile normal saline in the block

    Drug: Placebo: sterile normal saline

  • Active comparator
    Marcaine

    Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.

    Drug: Marcaine

Interventions

  • DrugPlacebo: sterile normal saline

    Bilateral TAP block using 20 ml of normal sterile saline per block.

    Also known as: Saline water, Saline solution, Sodium chloride, NaCl, Salt

  • Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.

    Also known as: Bupivacaine

06

What researchers measure

Primary outcomes

  1. 24h morphine consumption

    Time frame: 24h after the block is given

Secondary outcomes

  1. Post operative nausea score

    none = 0; mild = 1; moderate = 2; severe = 3

    Time frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.

  2. Measurement of lung function (FEV1 and FVC)

    Time frame: Before surgery and 24h after.

  3. The Verbal Analogue Scale (VAS) scores at rest and on moving

    Time frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.

07

Study locations

1 site
  • Privathospitalet Hamlet Aarhus
    Aarhus N, 8200, Denmark
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2011, a primary completion of Feb 2013 and a completion of Feb 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 2, 2011
First posted
Mar 4, 2011
Start
Feb 2011
Primary completionActual
Feb 2013
CompletionActual
Feb 2013
Last update
Mar 26, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01308554
Lead sponsor
Funch-Jensen, Peter, M.D., D.M.Sc.
Collaborators
Medtronic - MITG
Responsible party
Sponsor
First posted
Mar 4, 2011
Start date
Feb 2011
Primary completion
Feb 2013
Completion
Feb 2013
Last update
Mar 26, 2014

Study contacts

Peter Funch-Jensen, D.M.Sc.
principal investigator · Privathospital Hamlet Aarhus, Denmark

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bupivacaine

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