Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.
Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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.
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Aarhus N, Denmark, 8200
- Privathospitalet Hamlet Aarhus
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Sterile normal saline
Control group will receive sterile normal saline in the block
|
Bilateral TAP block using 20 ml of normal sterile saline per block.
Other Names:
|
|
ACTIVE_COMPARATOR: Marcaine
Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side.
|
Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
24h morphine consumption
Time Frame: 24h after the block is given
|
24h after the block is given
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post operative nausea score
Time Frame: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.
|
none = 0; mild = 1; moderate = 2; severe = 3
|
Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.
|
|
Measurement of lung function (FEV1 and FVC)
Time Frame: Before surgery and 24h after.
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Before surgery and 24h after.
|
|
|
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.
|
Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Peter Funch-Jensen, D.M.Sc., Privathospital Hamlet Aarhus, Denmark
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- TAP1
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