PainPhase 4NCT01308554
Pain Relieving Efficacy of TAP Block in Patients After Laparoscopic Gastric Bypass.
A Phase 4 study testing Marcaine in people with Pain and Obesity, run by Funch-Jensen, Peter, M.D., D.M.Sc. at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Marcaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2011to Feb 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.
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.
- Conditions
- Pain, Obesity, Surgery, Neuromuscular Inhibition
- Being tested
- Placebo: sterile normal saline, Marcaine
- Keywords
- TAP block, Pain, Obesity, Surgery, Laparoscopic gastric bypass
- Medical subject headings
- Pain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo: sterile normal salineDrug
Also called Saline water, Saline solution, Sodium chloride, NaCl
Bilateral TAP block using 20 ml of normal sterile saline per block.
MarcaineDrug
Also called Bupivacaine
Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.
| Study group | Role | What they receive |
|---|---|---|
| Sterile normal saline | Placebo comparator | Control group will receive sterile normal saline in the block Receives: Drug: Placebo: sterile normal saline |
| Marcaine | Active comparator | Study group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side. Receives: Drug: Marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h morphine consumption
Measured: 24h after the block is given
Secondary outcomes (3)
Post operative nausea score
none = 0; mild = 1; moderate = 2; severe = 3
Measured: 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)
Measured: Before surgery and 24h after.
The Verbal Analogue Scale (VAS) scores at rest and on moving
Measured: Before surgery and every second hour after surgery until nighttime and again three measurements each day for two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Funch-Jensen, Peter, M.D., D.M.Sc.
- Collaborators
- Medtronic - MITG
- Responsible party
- Sponsor
- Investigators
- Peter Funch-Jensen, D.M.Sc., Principal investigator, Privathospital Hamlet Aarhus, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01308554
- Sponsor's protocol ID
- TAP1
- Status last verified
- Mar 2014
- First submitted
- 2 Mar 2011
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Ultrasound-guided Single Shot Subcostal Transversus Abdominis Plane (TAP) Block After Laparoscopic Gastric Bypass.
- ClinicalTrials.gov ID
- NCT01308554
- Acronym / sponsor ID
- TAP1
- Conditions
- Pain, Obesity, Surgery, Neuromuscular Inhibition
- Keywords
- TAP block, Pain, Obesity, Surgery, Laparoscopic gastric bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Funch-Jensen, Peter, M.D., D.M.Sc.
- Collaborators
- Medtronic - MITG
- Study start
- Feb 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 4 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile normal saline | Placebo comparator | Drug: Placebo: sterile normal salineControl group will receive sterile normal saline in the block |
| Marcaine | Active comparator | Drug: MarcaineStudy group will receive a bilateral TAP block using 20 ml of Marcaine 2,5 mg/ml on each side. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Placebo: sterile normal salineAlso: Saline water, Saline solution, Sodium chloride, NaClBilateral TAP block using 20 ml of normal sterile saline per block. | Drug | Sterile normal saline |
| MarcaineAlso: BupivacaineStudy group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side. | Drug | Marcaine |
Primary outcome
24h morphine consumption
Time frame: 24h after the block is given
3 secondary outcomes
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.
Measurement of lung function (FEV1 and FVC)
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2014.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
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.
Peter Funch-Jensen, D.M.Sc. principal investigator
Privathospital Hamlet Aarhus, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Marcaine in people with Pain and Obesity, run by Funch-Jensen, Peter, M.D., D.M.Sc. at 1 site in Denmark.
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 26 Mar 2014. 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 Denmark. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
24h morphine consumption (time frame: 24h after the block is given). 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 26 Mar 2014.