Post Operative AnalgesiaNCT03577912
Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: Surgeon vs Anesthesia - Ultrasound Guidance
A study testing TAP block administered by Surgery and TAP block administered by Anesthesia in people with Post Operative Analgesia and Non-inferiority Trial, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Operative Analgesia, Non-inferiority Trial
- What is being tested?
- TAP block administered by Surgery and TAP block administered by Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2015to 31 Jul 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all consecutive patients undergoing laparoscopic colorectal resection in the division of colorectal surgery from March 2016 and April 2018 were eligible.
- Over 18 years old
- Intellect sufficient to sign consent, interpret analog pain scale
Who cannot join
- allergies to bupivacaine or epinephrine
- preoperative chronic narcotic usage
- chronic pain syndrome
- anatomy thought to preclude effective placement of the TAP.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: A Comparison Between Intraoperative Surgeon Administration by Direct Visualization vs Image Guided Administration by Anesthesiologist, a Prospective Randomized Controlled Trial
The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.There are many methods to administer local anesthetic into the transversus abdominus plane to provide post-operative analgesia. The more prevalent method is for an anesthesia provider to inject local anesthetic into the plane using ultrasound guidance, before surgery or after the conclusion of surgery. Alternatively, a surgeon can administer the local anesthetic during the operation without additional time or expense using direct laparoscopic visualization. We propose to compare the two methods for non-inferiority, in the context of an established enhanced recovery after surgery (ERAS) program. Non-inferiority being established by no demonstrable difference in post-operative narcotic requirements and equivalent average pain scores.
Read the detailed description
Purpose: To demonstrate that TAP blockade administered by the surgeon during surgery is as effective as when placed as a separate procedure by an anesthesiologist under ultrasound guidance by head to head randomized comparison controlling for medication, concentration volume and location.
Introduction:
The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The ventral rami of the segmental thoracolumbar nerves course through the TAP before innervating the anterolateral abdominal wall. The TAP block has been shown to provide postoperative analgesia following abdominal surgery. Prospective randomized trials have demonstrated analgesic efficacy of TAP block and cadaveric studies have shown reliable dye spread from T9-L1 (iliac crest to the costal margin) , although the spread is dependent upon the technique of injection, single versus multiple injections. The TAP block is an intermuscular plane block i.e., needle placed in the plane between the internal oblique and transversus abdominis muscles. The sensory fibers located in this plane is too small to be visualized by ultrasound or localized by nerve stimulation. The TAP block may be performed in patients under general anesthesia since nerve localization is not necessary. This block has a number of advantages which include technical simplicity, high analgesic effectiveness, opioid sparing, long duration of effect, up to 36 hours, minimal side effects in comparison to that associated with neuraxial analgesia (e.g., hypotension, motor blockade). TAP block has successfully been incorporated in enhanced recovery after surgery (ERAS) protocols to reduce postoperative pain, reduce post op narcotic requirement, provide earlier return of bowel function and reduce length of stay. However multiple techniques for placement of the block have been described, in differing locations and with differing agents to analgesia after a variety of procedures. Historically the block has been placed based on anatomic land marks in the triangle of Petit guided by the sensation of the administrator. The safety and anatomic reliability of this approach has been questioned. Currently the block is frequently placed by an anesthesiologist under ultrasound guidance. Recently there have been published reports of surgeons placing TAP blocks intraoperatively guided by palpation and direct visualization, both open and with laparoscopic visualization . It is currently the practice in the division of colon and rectal surgery to use a standardized method for placing a TAP block after open and laparoscopic abdominal colon and rectal cases as part of our ERAS protocol requiring minimal time and cost limited to the cost of the medication. The authors hypothesize that TAP block administered by the surgeon is as effective as when administered by an anesthesiologist under ultrasonic guidance controlling for medication, volume, concentration and location of placement.
Methods: This study is a randomized trial with a placebo control arm to confirm effectiveness of the block its self, as TAP block is fully adopted as standard practice throughout abdominal surgery. Consecutive patients 18 years old or greater with intellectual capacity to consent, who are scheduled to undergo elective open or laparoscopic abdominal surgery by the division of colorectal surgery, will be offered inclusion in the study. Choice of open versus laparoscopic procedure is at surgeons discretion based on the patient's condition, diagnosis and best practice. Those patients whose procedure begins laparoscopically who require conversion to laparotomy will be noted and included in the open group. Exclusions will include patients who have allergies to the medications, patients with a preoperative addiction to narcotics or chronic pain syndromes requiring chronic medication, or whose anatomy or procedure precludes placement of the block.
Consenting patients will be randomized to receive administration of a TAP block either intraoperatively by the surgeon by direct palpation and/or visualization or by an anesthesiologist under ultrasound guidance. Secondary randomization will assign 1/4rd of both arms to receive placebo. In treatment arm cases Marcaine 0.25% with epinephrine 1:200,000 in a volume in ccs equal to the patients weight in Kg will be delivered. Those assigned to placebo will receive an equivalent volume of saline. In all cases the block will be placed at the conclusion of the case; for the surgeon, prior to closure of the abdomen, for the anesthesiologist after skin closure but prior to emergence from general anesthesia.
The volume will be divided equally, bilaterally and injection via needle and syringe into the transversus abdominis muscle plane lateral to the border of the rectus muscle at the level of the umbilicus. In cases of longer xyphoid to pubis laparotomy incisions the volume of injection can be further divided to be injected superiorly and inferiorly in the abdominal wall to assure adequate distribution. In all cases the injection will be performed under general anesthesia after the completion of the case either immediately before closure of the abdominal incision(s) or immediately after closure, prior to emergence from anesthesia.
The patients and the data collection staff will be blinded at to the medication vs placebo and the method of administration.
Post operatively all patients in all groups will be included in a standard post-operative ERAS pathway including use of intravenous ketorolac and acetaminophen, metoclopramide, early ambulation. All patients will have access to standard post-operative analgesia including intravenous narcotics (morphine, hydromorphone) patient controlled analgesia (PCA) and PO analgesia acetaminophen, ibuprofen, oxycodone.
- Conditions
- Post Operative Analgesia, Non-inferiority Trial
- Being tested
- TAP block administered by Surgery, TAP block administered by Anesthesia
- Keywords
- ERAS, transversus_abdominis_plane_block, postoperative_pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP block administered by SurgeryProcedure or surgery
TAP block administered by Surgery
TAP block administered by AnesthesiaProcedure or surgery
TAP block administered by Anesthesia
| Study group | Role | What they receive |
|---|---|---|
| TAP block administered by Surgery | Active comparator | transversus abdominis (TAP) plane block is performed by the surgeon at the conclusion of the surgery, still under general anesthesia, prior to removing the trocars a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under direct surgeon observed laparoscopic visualization. (Split dose 30cc/side) Receives: Procedure: TAP block administered by Surgery |
| TAP block administered by Anesthesia | Active comparator | transversus abdominis (TAP) plane block is performed by the anesthesiologist at the conclusion of the surgery after incisions are closed and dressing are on, prior to emergence from general anesthesia, a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under by the anesthesiologist using ultrasound visualization. (Split dose 30cc/side) Receives: Procedure: TAP block administered by Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
narcotic requirement
overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery
Measured: first 48 hours after surgery
visual analogue pain scale - resting
visual analogue pain scale 0-10 observed at rest in the post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)
Measured: first 48 hours after surgery
visual analogue pain scale - moving
visual analogue pain scale 0-10 observed with motion in post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)
Measured: first 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start17 Aug 2015
- Primary completion12 Apr 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Post Operative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective, randomized, patient and observer blinded non-inferiority trial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Cataldo, Beth Israel Deaconess Medical Center
- Investigators
- Thomas E Cataldo, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577912
- Sponsor's protocol ID
- 2014P000347
- Status last verified
- Sep 2018
- First submitted
- 25 Jun 2018
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
PubMed 21328298Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
PubMed 23575408Lee L, Mata J, Ghitulescu GA, Boutros M, Charlebois P, Stein B, Liberman AS, Fried GM, Morin N, Carli F, Latimer E, Feldman LS. Cost-effectiveness of Enhanced Recovery Versus Conventional Perioperative Management for Colorectal Surgery. Ann Surg. 2015 Dec;262(6):1026-33. doi: 10.1097/SLA.0000000000001019.
PubMed 25371130Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.
PubMed 28682962Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
PubMed 28564673Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.
PubMed 29381824Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
PubMed 22632762Pirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
PubMed 28667547Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
PubMed 23965191Keller DS, Ermlich BO, Delaney CP. Demonstrating the benefits of transversus abdominis plane blocks on patient outcomes in laparoscopic colorectal surgery: review of 200 consecutive cases. J Am Coll Surg. 2014 Dec;219(6):1143-8. doi: 10.1016/j.jamcollsurg.2014.08.011. Epub 2014 Sep 16.
PubMed 25442068Gao T, Zhang JJ, Xi FC, Shi JL, Lu Y, Tan SJ, Yu WK. Evaluation of Transversus Abdominis Plane (TAP) Block in Hernia Surgery: A Meta-analysis. Clin J Pain. 2017 Apr;33(4):369-375. doi: 10.1097/AJP.0000000000000412.
PubMed 27518492Favuzza J, Delaney CP. Laparoscopic-guided transversus abdominis plane block for colorectal surgery. Dis Colon Rectum. 2013 Mar;56(3):389-91. doi: 10.1097/DCR.0b013e318280549b.
PubMed 23392158McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.
PubMed 17179269Park SY, Park JS, Choi GS, Kim HJ, Moon S, Yeo J. Comparison of Analgesic Efficacy of Laparoscope-Assisted and Ultrasound-Guided Transversus Abdominis Plane Block after Laparoscopic Colorectal Operation: A Randomized, Single-Blind, Non-Inferiority Trial. J Am Coll Surg. 2017 Sep;225(3):403-410. doi: 10.1016/j.jamcollsurg.2017.05.017. Epub 2017 Jun 10.
PubMed 28610880Fields AC, Gonzalez DO, Chin EH, Nguyen SQ, Zhang LP, Divino CM. Laparoscopic-Assisted Transversus Abdominis Plane Block for Postoperative Pain Control in Laparoscopic Ventral Hernia Repair: A Randomized Controlled Trial. J Am Coll Surg. 2015 Aug;221(2):462-9. doi: 10.1016/j.jamcollsurg.2015.04.007. Epub 2015 Apr 22.
PubMed 26206644
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Transversus Abdominis Plane (TAP) Block Techniques: A Comparison Between Intraoperative Surgeon Administration by Direct Visualization vs Image Guided Administration by Anesthesiologist, a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03577912
- Acronym / sponsor ID
- 2014P000347
- Conditions
- Post Operative Analgesia, Non-inferiority Trial
- Keywords
- ERAS, transversus_abdominis_plane_block, postoperative_pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 17 Aug 2015 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 5 Jul 2018 (actual)
- 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 transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The TAP block has been shown to provide postoperative analgesia following abdominal surgery.There are many methods to administer local anesthetic into the transversus abdominus plane to provide post-operative analgesia. The more prevalent method is for an anesthesia provider to inject local anesthetic into the plane using ultrasound guidance, before surgery or after the conclusion of surgery. Alternatively, a surgeon can administer the local anesthetic during the operation without additional time or expense using direct laparoscopic visualization. We propose to compare the two methods for non-inferiority, in the context of an established enhanced recovery after surgery (ERAS) program. Non-inferiority being established by no demonstrable difference in post-operative narcotic requirements and equivalent average pain scores.
Detailed description
Purpose: To demonstrate that TAP blockade administered by the surgeon during surgery is as effective as when placed as a separate procedure by an anesthesiologist under ultrasound guidance by head to head randomized comparison controlling for medication, concentration volume and location.
Introduction:
The transversus abdominis plane (TAP) block is a regional anesthesia technique where local anesthetic is injected into the neurovascular plane between the transversus abdominis and internal oblique muscles. The ventral rami of the segmental thoracolumbar nerves course through the TAP before innervating the anterolateral abdominal wall. The TAP block has been shown to provide postoperative analgesia following abdominal surgery. Prospective randomized trials have demonstrated analgesic efficacy of TAP block and cadaveric studies have shown reliable dye spread from T9-L1 (iliac crest to the costal margin) , although the spread is dependent upon the technique of injection, single versus multiple injections. The TAP block is an intermuscular plane block i.e., needle placed in the plane between the internal oblique and transversus abdominis muscles. The sensory fibers located in this plane is too small to be visualized by ultrasound or localized by nerve stimulation. The TAP block may be performed in patients under general anesthesia since nerve localization is not necessary. This block has a number of advantages which include technical simplicity, high analgesic effectiveness, opioid sparing, long duration of effect, up to 36 hours, minimal side effects in comparison to that associated with neuraxial analgesia (e.g., hypotension, motor blockade). TAP block has successfully been incorporated in enhanced recovery after surgery (ERAS) protocols to reduce postoperative pain, reduce post op narcotic requirement, provide earlier return of bowel function and reduce length of stay. However multiple techniques for placement of the block have been described, in differing locations and with differing agents to analgesia after a variety of procedures. Historically the block has been placed based on anatomic land marks in the triangle of Petit guided by the sensation of the administrator. The safety and anatomic reliability of this approach has been questioned. Currently the block is frequently placed by an anesthesiologist under ultrasound guidance. Recently there have been published reports of surgeons placing TAP blocks intraoperatively guided by palpation and direct visualization, both open and with laparoscopic visualization . It is currently the practice in the division of colon and rectal surgery to use a standardized method for placing a TAP block after open and laparoscopic abdominal colon and rectal cases as part of our ERAS protocol requiring minimal time and cost limited to the cost of the medication. The authors hypothesize that TAP block administered by the surgeon is as effective as when administered by an anesthesiologist under ultrasonic guidance controlling for medication, volume, concentration and location of placement.
Methods: This study is a randomized trial with a placebo control arm to confirm effectiveness of the block its self, as TAP block is fully adopted as standard practice throughout abdominal surgery. Consecutive patients 18 years old or greater with intellectual capacity to consent, who are scheduled to undergo elective open or laparoscopic abdominal surgery by the division of colorectal surgery, will be offered inclusion in the study. Choice of open versus laparoscopic procedure is at surgeons discretion based on the patient's condition, diagnosis and best practice. Those patients whose procedure begins laparoscopically who require conversion to laparotomy will be noted and included in the open group. Exclusions will include patients who have allergies to the medications, patients with a preoperative addiction to narcotics or chronic pain syndromes requiring chronic medication, or whose anatomy or procedure precludes placement of the block.
Consenting patients will be randomized to receive administration of a TAP block either intraoperatively by the surgeon by direct palpation and/or visualization or by an anesthesiologist under ultrasound guidance. Secondary randomization will assign 1/4rd of both arms to receive placebo. In treatment arm cases Marcaine 0.25% with epinephrine 1:200,000 in a volume in ccs equal to the patients weight in Kg will be delivered. Those assigned to placebo will receive an equivalent volume of saline. In all cases the block will be placed at the conclusion of the case; for the surgeon, prior to closure of the abdomen, for the anesthesiologist after skin closure but prior to emergence from general anesthesia.
The volume will be divided equally, bilaterally and injection via needle and syringe into the transversus abdominis muscle plane lateral to the border of the rectus muscle at the level of the umbilicus. In cases of longer xyphoid to pubis laparotomy incisions the volume of injection can be further divided to be injected superiorly and inferiorly in the abdominal wall to assure adequate distribution. In all cases the injection will be performed under general anesthesia after the completion of the case either immediately before closure of the abdominal incision(s) or immediately after closure, prior to emergence from anesthesia.
The patients and the data collection staff will be blinded at to the medication vs placebo and the method of administration.
Post operatively all patients in all groups will be included in a standard post-operative ERAS pathway including use of intravenous ketorolac and acetaminophen, metoclopramide, early ambulation. All patients will have access to standard post-operative analgesia including intravenous narcotics (morphine, hydromorphone) patient controlled analgesia (PCA) and PO analgesia acetaminophen, ibuprofen, oxycodone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- prospective, randomized, patient and observer blinded non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| TAP block administered by Surgery | Active comparator | Procedure: TAP block administered by Surgerytransversus abdominis (TAP) plane block is performed by the surgeon at the conclusion of the surgery, still under general anesthesia, prior to removing the trocars a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under direct surgeon observed laparoscopic visualization. (Split dose 30cc/side) |
| TAP block administered by Anesthesia | Active comparator | Procedure: TAP block administered by Anesthesiatransversus abdominis (TAP) plane block is performed by the anesthesiologist at the conclusion of the surgery after incisions are closed and dressing are on, prior to emergence from general anesthesia, a single dose 60 cc of 0.5%bupivicaine is delivered into the TAP under by the anesthesiologist using ultrasound visualization. (Split dose 30cc/side) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- all consecutive patients undergoing laparoscopic colorectal resection in the division of colorectal surgery from March 2016 and April 2018 were eligible.
- Over 18 years old
- Intellect sufficient to sign consent, interpret analog pain scale
Key exclusion criteria (4 listed)
- allergies to bupivacaine or epinephrine
- preoperative chronic narcotic usage
- chronic pain syndrome
- anatomy thought to preclude effective placement of the TAP.
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 |
|---|---|---|
| TAP block administered by SurgeryTAP block administered by Surgery | Procedure or surgery | TAP block administered by Surgery |
| TAP block administered by AnesthesiaTAP block administered by Anesthesia | Procedure or surgery | TAP block administered by Anesthesia |
Primary outcome
narcotic requirement
Time frame: first 48 hours after surgery
overall narcotic medications used by the patient (in morphine equivalents)PACU, 6,12,25,and 48 hours after surgery
visual analogue pain scale - resting
Time frame: first 48 hours after surgery
visual analogue pain scale 0-10 observed at rest in the post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)
visual analogue pain scale - moving
Time frame: first 48 hours after surgery
visual analogue pain scale 0-10 observed with motion in post-anesthesia care unit, 6,12,25,and 48 hours after surgery (0 = no pain, 10 = worst imaginable pain)
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 17 Sep 2018.
- Background: PubMed 21328298Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
- Background: PubMed 23575408Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
- Background: PubMed 25371130Lee L, Mata J, Ghitulescu GA, Boutros M, Charlebois P, Stein B, Liberman AS, Fried GM, Morin N, Carli F, Latimer E, Feldman LS. Cost-effectiveness of Enhanced Recovery Versus Conventional Perioperative Management for Colorectal Surgery. Ann Surg. 2015 Dec;262(6):1026-33. doi: 10.1097/SLA.0000000000001019.
- Background: PubMed 28682962Carmichael JC, Keller DS, Baldini G, Bordeianou L, Weiss E, Lee L, Boutros M, McClane J, Feldman LS, Steele SR. Clinical Practice Guidelines for Enhanced Recovery After Colon and Rectal Surgery From the American Society of Colon and Rectal Surgeons and Society of American Gastrointestinal and Endoscopic Surgeons. Dis Colon Rectum. 2017 Aug;60(8):761-784. doi: 10.1097/DCR.0000000000000883. No abstract available.
- Background: PubMed 28564673Wick EC, Grant MC, Wu CL. Postoperative Multimodal Analgesia Pain Management With Nonopioid Analgesics and Techniques: A Review. JAMA Surg. 2017 Jul 1;152(7):691-697. doi: 10.1001/jamasurg.2017.0898.
- Background: PubMed 29381824Hain E, Maggiori L, Prost A la Denise J, Panis Y. Transversus abdominis plane (TAP) block in laparoscopic colorectal surgery improves postoperative pain management: a meta-analysis. Colorectal Dis. 2018 Apr;20(4):279-287. doi: 10.1111/codi.14037.
- Background: PubMed 22632762Johns N, O'Neill S, Ventham NT, Barron F, Brady RR, Daniel T. Clinical effectiveness of transversus abdominis plane (TAP) block in abdominal surgery: a systematic review and meta-analysis. Colorectal Dis. 2012 Oct;14(10):e635-42. doi: 10.1111/j.1463-1318.2012.03104.x.
- Background: PubMed 28667547Pirrera B, Alagna V, Lucchi A, Berti P, Gabbianelli C, Martorelli G, Mozzoni L, Ruggeri F, Ingardia A, Nardi G, Garulli G. Transversus abdominis plane (TAP) block versus thoracic epidural analgesia (TEA) in laparoscopic colon surgery in the ERAS program. Surg Endosc. 2018 Jan;32(1):376-382. doi: 10.1007/s00464-017-5686-7. Epub 2017 Jul 1.
- Background: PubMed 23965191Elkassabany N, Ahmed M, Malkowicz SB, Heitjan DF, Isserman JA, Ochroch EA. Comparison between the analgesic efficacy of transversus abdominis plane (TAP) block and placebo in open retropubic radical prostatectomy: a prospective, randomized, double-blinded study. J Clin Anesth. 2013 Sep;25(6):459-65. doi: 10.1016/j.jclinane.2013.04.009. Epub 2013 Aug 17.
- Background: PubMed 25442068Keller DS, Ermlich BO, Delaney CP. Demonstrating the benefits of transversus abdominis plane blocks on patient outcomes in laparoscopic colorectal surgery: review of 200 consecutive cases. J Am Coll Surg. 2014 Dec;219(6):1143-8. doi: 10.1016/j.jamcollsurg.2014.08.011. Epub 2014 Sep 16.
- Background: PubMed 27518492Gao T, Zhang JJ, Xi FC, Shi JL, Lu Y, Tan SJ, Yu WK. Evaluation of Transversus Abdominis Plane (TAP) Block in Hernia Surgery: A Meta-analysis. Clin J Pain. 2017 Apr;33(4):369-375. doi: 10.1097/AJP.0000000000000412.
- Background: PubMed 23392158Favuzza J, Delaney CP. Laparoscopic-guided transversus abdominis plane block for colorectal surgery. Dis Colon Rectum. 2013 Mar;56(3):389-91. doi: 10.1097/DCR.0b013e318280549b.
- Individual participant dataSharing planned: No
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Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty
Osteoarthritis, Hip, Hip Osteoarthritis
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
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.
Thomas E Cataldo, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP block administered by Surgery and TAP block administered by Anesthesia in people with Post Operative Analgesia and Non-inferiority Trial, run by Beth Israel Deaconess Medical Center 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 3 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 17 Sep 2018. 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?
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?
narcotic requirement (time frame: first 48 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03577912, which also lists 25 linked publications.
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 17 Sep 2018.