AzTrials
AzTrials

Nerve BlockNCT01871168

Continuous TAP Blocks - Pain & Plasma LA Levels

A study testing TAP block in people with Nerve Block and Pain, Postoperative, run by University of Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to establish an alternative method of postoperative pain control to the current standard of practice, patient-controlled analgesia with intravenous opioids, for patients undergoing a major major abdominal surgery at the University of Alberta Hospital. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Nerve Block, Pain, Postoperative
What is being tested?
TAP block
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteCanada
Study dates
May 2013to Nov 2017
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients undergoing major abdominal surgery who consent to a continuous transversus abdominis nerve block as part of their postoperative management

Who cannot join

  • History of allergy to local anesthesia
  • Infection in the area of intended catheter insertion
  • Opiate tolerance
  • Failure to consent

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2G3

Other trials in Canada

About this study

Official title: Continuous Transversus Abdominis Plane Blocks for Patients Undergoing Major Abdominal Surgery: A Prospective, Controlled, Randomized, Double-blind Trial

The purpose of this study is to establish an alternative method of postoperative pain control to the current standard of practice, patient-controlled analgesia with intravenous opioids, for patients undergoing a major major abdominal surgery at the University of Alberta Hospital. The primary objective is to determine whether a continuous transversus abdominis plane (TAP) block, run until the third postoperative day, will reduce the amount of intravenous morphine required. Additionally, the investigators propose to measure the amount of local anesthetic (lidocaine) in the blood during this time frame to provide patient safety data for this procedure. This will be a prospective controlled randomized double-blind clinical trial. The patients, anesthesiologists and staff providing post operative care will be blinded to group assignment. Patients will be randomized by sealed envelopes.

Read the detailed description

INTRODUCTION The use of peripheral nerve blocks has become increasingly popular in the last two decades. With the use of anatomical landmark-based techniques, peripheral nerve stimulators, or ultrasound-guided techniques, novel types of nerve blocks have been made possible with both new indications as well as a lower risk of complications for the patient. The transversus abdominis plane (TAP) block is a newly developed block involving the nerves of the anterior abdominal wall. Recent published clinical trials involving patients undergoing both major abdominal as well as gynaecological surgery, have demonstrated promising results with this technique as part of a multimodal post-operative pain treatment. There was a recent review article summarizing the results of the available studies. This review article presents a brief summary of the methods used for the TAP block. Clinical studies of the effect of the TAP block on post-operative pain were systematically searched and reviewed. Suggestions for future assessment and use of the TAP block were discussed. McDonnell and O'Donnell recently found a series of TAP Blocks placed via the triangle of Petit to be effective in reducing postoperative pain in major abdominal surgery. Hebbard suggests placing TAP blocks from a subcostal oblique approach for surgery above the umbilicus. Our personal experiences with postoperative analgesia via TAP blocks in patients undergoing supraumbilical laparotomy coincide with Dr.

Hebbard's opinion. This is why for this study we propose placing TAP catheters in our patients via a subcostal oblique approach. Pain following abdominal surgery is largely derived from abdominal wall incision. The anatomy of the abdominal wall and nerve supply is well described. The anterior abdominal wall has a central and lateral component. The central abdominal wall consists of the rectus sheath, which includes the rectus abdominal muscle, and associated fascial sheaths. The lateral wall consists of the external oblique, the internal oblique and the transversus abdominis muscles and their fascial sheaths. Sensory supply to the anterior abdominal wall including skin, muscle and parietal peritoneum is derived from the anterior rami of the lower six thoracic nerves and the first lumbar nerves. The nerves pass through the lateral fascial plane between the internal oblique and transversus abdominis muscles termed the transversus abdominis fascial plane. These nerves can be blocked utilizing the transversus abdominis plane block using a double pop technique or using ultrasound. Preliminary volunteer and cadaveric studies have demonstrated the potential for the TAP block to produce a dermatomal sensory block of the lower six thoracic and first lumbar abdominal afferents.

Postoperative analgesia for patients undergoing major abdominal surgery, such as hepatectomy, liver transplantation, or Whipple's Surgery is an issue of debate in the anesthetic society. While epidural analgesia is widely accepted as the best method for postoperative pain control in most major abdominal surgery, the safety of epidural catheters in patients undergoing liver or pancreatic resections is contested. Postoperative coagulopathy, which develops to an extent in every patient with resection of liver and which is directly correlated to the amount of liver resected, puts the patient at risk of developing a spinal hematoma - particularly with removal of the catheter. Coagulopathy also exists to a degree in patients with pancreatic cancer and obstructive jaundice, therefore the question as to the safety of an epidural catheter in these patients is debatable. As large doses of anesthetic are injected into a relatively vascular area during TAP blocks, there exists the potential for toxicity. Two recent studies have examined serum levels of lidocaine and ropivacaine after TAP block using standard local anesthetic volumes and found serum levels consistent with potential systemic toxicity. However, there is no literature on serum local anesthetic levels during continuous TAP block. Serum lidocaine plasma levels will be measured in patients randomized to receive TAP block with or without intermittent local anesthetic bolusing postoperatively to provide patient safety data for this procedure. OBJECTIVE To determine whether a continuous transversus abdominis plane block run until the third postoperative day will reduce patient postoperative pain scores and reduce the amount of intravenous morphine required for major abdominal surgery and to quantify plasma lidocaine levels. HYPOTHESIS Patients receiving continuous TAP block with lidocaine use less PCA morphine post-operatively compared to patients receiving placebo through TAP catheters. METHODS Following Institutional Ethics Board Approval, forty patients undergoing major abdominal surgery (the number was chosen according to previous similar studies) will be randomly allocated to TAP block with postoperative intermittent infusion of 0.5-1.0% lidocaine versus TAP block with postoperative intermittent infusion of placebo (i.e. saline). All patients will receive a standard general anesthetic and all patients will receive the current postoperative analgesic standard of care in our hospital, which is an intravenous morphine PCA pump combined with adjunctive medication. The presence and severity of pain, sedation and nausea will be assessed by an investigator blinded to group allocation. These assessments will be done by one of the investigators at 24, 48, 72, and 96 hours after the TAP blockade. Pain will be assessed at rest and on movement using the visual analogue score. Sedation scores shall be assigned to awake or alert=0, quietly awake=1, asleep but easily aroused=2, deep sleep=3. Sedation will be defined as the presence of sedation score greater than 0 at any time point. Nausea will be defined by the administration of rescue antiemetics. Morphine requirements at 24, 48, 72, and 96 hours will be assessed for all patients. Also we will evaluate any extra medication a patient may have required, time to first bowel movement, time to first mobilization, discharge date, and any complications such as wound infection, ileus, local anesthetic toxicity, or catheter dislocation. All patients who have a unilateral incision will receive a TAP catheter placed intraoperatively by the surgeon. Under direct visualization, the surgeon will first close the muscle layer of the transversus abdominis.

Then a standard nerve block catheter will be inserted percutaneously from just lateral to the rectus abdominis muscle cephalad to the incision. The catheter will then be placed in an oblique direction along the border of the 12th rib and the tip will be placed as far lateral as the incision allows without dissecting any further tissue. The surgeon will then close the muscle layer of the internal oblique over the catheter and in a third layer close the external oblique and subcutaneous tissue before closing skin. The catheter will be fixed to skin via a specialized taping system, which we use to secure all nerve catheters, obliviating the need to suture the catheter to skin and thus running the risk of occluding it. In the event that surgical incision crosses midline and is bilateral, the surgeon will place a second TAP catheter in the method described above on the contralateral side. Our postoperative pain regimen will include the following. All patients will receive the current standard of care in our hospital, which is an intravenous morphine PCA pump. Additionally the patient will be able to receive a breakthrough dose of i.v. morphine prn. All patients will have adjunctive medications ordered.

Regarding infusion into the TAP catheter, all patients will receive intermittent boluses of either lidocaine (0.5-1.0%, at the discretion of the anesthesiologist) or placebo into their TAP catheters. For patients with unilateral incisions, a bolus of 20-40 ml will be applied every four to eight hours by our pumps. A KVO rate of 1 ml per hour will run throughout. Should it be necessary to place catheters bilaterally, we will set a second pump for the second catheter. This pump will be set with identical settings, i.e. will deliver 20-40 ml of solution every four to eight hours. Blood will be sampled for plasma lidocaine levels through the already sited intravenous line at 30 minutes postoperatively, as well as immediately before and 30 minutes after one local anesthetic or placebo bolus each day for three days postoperatively. The TAP catheter will be removed after approximately 72 hours on the morning of the third postoperative day.

Being tested
TAP block, Sham TAP block
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAP blockProcedure or surgery

    Infusion of 0.5-1% lidocaine

  • Sham TAP blockProcedure or surgery

    Infusion of saline

Study groups in NCT01871168
Study groupRoleWhat they receive
Sham TAP blockSham comparatorPatients receive TAP catheters but saline infusion instead of local anesthetic
Receives: Procedure: Sham TAP block
TAP blockExperimentalPatients receive a continuous TAP block
Receives: Procedure: TAP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine requirements following major abdominal surgery

    Morphine consumption will be measured every 24 hours following surgery.

    Measured: 96 hours post-surgery

Secondary outcomes (4)
  1. Pain

    Pain will be recorded every 24 hours following surgery on a VAS scale.

    Measured: 96 hours post-surgery

  2. Sedation

    Sedation will be assessed every 24 hours following surgery using a 4-point scale.

    Measured: 96 hours post-surgery

  3. Nausea

    Nausea will be assessed every 24 hours following surgery using a 4-point scale.

    Measured: 96 hours post-surgery

  4. Systemic effects of lidocaine

    Blood will be sampled for plasma lidocaine levels through the already sited intravenous line at 30 minutes postoperatively, as well as immediately before and 30 minutes after one local anesthetic or placebo bolus each day for three days postoperatively.

    Measured: 72 hours post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionNov 2016
  4. Study completionNov 2017

Why it stopped: PI no longer at institution

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01871168
Sponsor's protocol ID
Pro00002507
Status last verified
Mar 2020
First submitted
3 Jun 2013
Last updated
25 Mar 2020
Results posted
No
Data monitoring committee
No

Publications

  • Petersen PL, Mathiesen O, Torup H, Dahl JB. The transversus abdominis plane block: a valuable option for postoperative analgesia? A topical review. Acta Anaesthesiol Scand. 2010 May;54(5):529-35. doi: 10.1111/j.1399-6576.2010.02215.x. Epub 2010 Feb 17.

    PubMed 20175754
  • McDonnell 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 17179269
  • Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.

    PubMed 18227342
  • Kato N, Fujiwara Y, Harato M, Kurokawa S, Shibata Y, Harada J, Komatsu T. Serum concentration of lidocaine after transversus abdominis plane block. J Anesth. 2009;23(2):298-300. doi: 10.1007/s00540-008-0721-4. Epub 2009 May 15.

    PubMed 19444577
  • Griffiths JD, Barron FA, Grant S, Bjorksten AR, Hebbard P, Royse CF. Plasma ropivacaine concentrations after ultrasound-guided transversus abdominis plane block. Br J Anaesth. 2010 Dec;105(6):853-6. doi: 10.1093/bja/aeq255. Epub 2010 Sep 22.

    PubMed 20861094

Questions about this trial

What is this clinical trial studying?

A study testing TAP block in people with Nerve Block and Pain, Postoperative, run by University of Alberta at 1 site in Canada.

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: stopped early, as of the sponsor's last update on 25 Mar 2020. 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 Canada. 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.

Are results available for this study?

The study was stopped early (reason given: PI no longer at institution). Results are not available in the source record.

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?

Morphine requirements following major abdominal surgery (time frame: 96 hours post-surgery). 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 NCT01871168, which also lists 5 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 25 Mar 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in