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Pain, PostoperativeNCT05497908

Feasibility of TAP for XLIF Surgery

A study testing TAP block via lateral approach and TAP block via posterior approach in people with Pain, Postoperative, run by Jessa Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Key questions of this feasibility trial will be the feasibility of performing the TAP block in XLIF patients, screen for safety of the block and preliminary investigate the influence on pain control and quality of recovery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
TAP block via lateral approach and TAP block via posterior approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteBelgium
Study dates
2 Sep 2022to 23 Sep 2024
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years or older
  • Scheduled for elective lumbar XLIF surgery
  • 1 level
  • multilevel
  • Patient being able to give informed consent
  • Patient being able to understand and use the PCIA system
  • Body Mass Index (BMI) ≤ 35 kg/m2

Who cannot join

  • - Refusal to participate
  • Chronic strong opioid use (WHO analgesic ladder step 3)
  • Allergy to local anesthetics
  • Antecedents of lumbar back surgery
  • Pregnancy

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Jessa Hospital

    Hasselt, Limburg, 3500

Other trials in Belgium

About this study

Official title: Transverse Abdominis Plane (TAP) Block in EXtreme Lateral Interbody Fusion (XLIF) Surgery: a Pilot Feasibility Trial

Key questions of this feasibility trial will be the feasibility of performing the TAP block in XLIF patients, screen for safety of the block and preliminary investigate the influence on pain control and quality of recovery. The investigators hypothesize that visualization of lateral TAP will be superior to visualization of posterior TAP, protocol adherence and safety profile to be excellent and both blocks to be superior in terms of analgesia compared to no block.

Read the detailed description

Enhanced recovery after surgery trajectories have been widely adopted after its first publications mentioned faster recovery and better patient outcomes whilst reducing costs . The recent COVID pandemic further emphasized the importance of reducing hospital length of stay for elective procedures, both from a patient quality as from an economic point of view. Minimally invasive surgical techniques are key in allowing enhanced recovery after surgery programs: eXtreme Lateral Interbody Fusion (XLIF) is one of those surgical techniques. XLIF has a reported enhanced recovery with a short hospital stay. On the other hand, multimodal anesthetic regimens with the potential to reduce the need for long-acting opioids are crucial in supporting early recovery after surgery. Regional anesthesia is an important element in multimodal analgesia. It has a significant effect on acute pain and reduces morphine consumption. Opioid sparing regional techniques obviously reduce opioid side effects leading to less postoperative nausea and vomiting (PONV), pruritus and drowsiness. Despite the increasing evidence for locoregional anesthetic techniques in enhanced recovery after surgery trajectories, the quest for the ideal regional technique, timing of block placement, local anesthetic and single shot versus catheter often remains a challenge. Traditional locoregional anesthetic techniques and spine surgery have known a reluctant relationship. Spine surgeons typically prefer optimal conditions for a decent neurologic examination after the surgical procedure to recognize early surgical complications. Classic neuraxial analgesia and peripheral nerve blocks might compromise this clinical neurologic follow-up. On the other hand, anesthetic guidelines raise concerns about the safety of locoregional anesthesia in patients with existing neurologic disease as neurologic conditions might worsen, especially after suboptimal application of locoregional techniques. However, during the last decade the practice of locoregional anesthesia expanded with the introduction of multiple planar blocks. In these blocks, local anesthetics are injected in a plane -usually an intermuscular plane- providing anesthesia to performant sensory nerve branches without affecting the motor function of the nerves. Clinically, in uttermost plane blocks a sensory blockade is achieved without the loss of ambulation. The thoracolumbar interfascial plane (TLIP) block and erector spinae block (ESB) were the first plane blocks to be introduced in spine surgery. A systematic review on the use of TLIP in back surgery found a significant lower use of perioperative opioids and PONV compared to no block or wound infiltration, as well as significantly lower postoperative pain scores compared to no block. However, concerns on blinding and a high allocation bias compromise the generalizability of this systematic review. The TLIP block also includes the risk for neuraxial injury and is a technically challenging block placed with the patient in uncomfortable prone position. Furthermore, the site of injection interferes with the corresponding surgical field. Therefore, some centers started performing the ESB for spine surgery. In a multicenter, non-blinded prospective trial a significant reduction in pain but not in opioid-consumption after bilateral ESB for major decompressive spine surgery was found. A retrospective case-matched study also found a reduction in pain scores and hospital length of stay but not in opioid use after posterior lumbar interbody fusion (PLIF). A blinded RCT in the Chinese population did find a significant reduction in pain scores and opioid requirements after lumbar fusion surgery. However, in this study the ESB was placed at a lower than conventional lumbar two (L2) level. This is important since the local anesthetics injected in the erector spinae plane spread towards the paravertebral and epidural spaces, targeting both the dorsal and ventral rami of the spinal nerve. Albeit, the ESB may affect motor function of the nerves in the surgical area, potentially interfering with intraoperative neuromonitoring as well as postoperative clinical neurologic examination. During XLIF surgery, indeed neuromonitoring is required to ensure a safe working corridor in relation to the lumbosacral plexus. Sofin et al. introduced the transversus abdominis plane (TAP) block for lumbar spine fusion via a lateral (LLIF) and anterior (ALIF) approach. In a feasibility trial, all patients received the block and no block-related adverse events were noted. The TAP block has been shown to be effective when used as an adjunct in multimodal analgesic strategies after abdominal surgery. First described by Rafi in 2001, the TAP block evolved from a blind landmark technique to an ultrasound-guided technique with subcostal and posterior variations. The abdominal wall block is achieved by injecting a high-volume, low concentration mixture of local anesthetics selectively between the interior and exterior abdominal muscles. Cadaver studies in which dye was injected found spread of the dye between the iliac crest, costal margin and rectus muscle with an average area of 45cm2. Additional MRI studies found retrograde spread of contrast to the paravertebral spaces between T4 and L1 when the TAP landmark technique and ultrasound-guided posterior approach were used. This in contrast to the subcostal and lateral TAP block where the spread pattern was confined to the anterior abdominal wall. Clinically, TAP block has been proven to be superior to placebo after a variety of abdominal surgeries such as inguinal hernia repair, open appendectomy, laparoscopic cystectomy and cesarean section. Furthermore, TAP catheters have shown non-inferiority for pain scores compared to epidural catheters after open renal and hepatobiliary surgery . Importantly, in these abdominal surgeries most patients still required some opioids for visceral analgesia. Therefore, experts suggest short stay procedures with the least visceral manipulation benefit most from single show abdominal wall blocks. The XLIF procedure might be an excellent indication for this TAP block since peritoneal manipulation is avoided in this surgical procedure. Last year, the earlier cited group by Sofin performed a retrospective study in 250 patients to investigate associations between TAP block and outcomes after LLIF/ALIF. They found a significantly shorter hospital length of stay (LOS) with TAP block after multivariate analysis. Opioid consumption and pain scores did not differ significantly. However, in the TAP group, a significantly larger proportion of patients had ALIF surgery. By consequence, the authors might not just have compared block versus no block but also have compared two types of surgery.

The effectiveness of TAP blocks on ALIF surgery is not unsurprising since the incision of ALIF surgery is fully comparable to the incision made during a cesarean section or to a surgical access for the lower abdominal region. To investigate the influence on outcome of TAP block after XLIF surgery however, the investigators will perform a prospective, randomized feasibility trial. Patients will be randomized on a 1:1:1 ratio in to three groups: lateral TAP block, posterior TAP block and no block. Key questions of this feasibility trial will be the feasibility of performing the TAP block in XLIF patients, screen for safety of the block and preliminary investigate the influence on pain control and quality of recovery. The investigators hypothesize visualization of lateral TAP will be superior to visualization of posterior TAP, protocol adherence and safety profile to be excellent and both blocks to be superior in terms of analgesia compared to no block.

Being tested
TAP block via lateral approach, TAP block via posterior approach
Keywords
eXtreme Lateral Interbody Fusion (XLIF) surgery, transversus abdominis plane (TAP) block
Medical subject headings
Pain, Postoperative, Bites and Stings

What participants receive

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

  • TAP block via lateral approachProcedure or surgery

    TAP block via lateral approach

  • TAP block via posterior approachProcedure or surgery

    TAP block via posterior approach

Study groups in NCT05497908
Study groupRoleWhat they receive
Transversus abdominis plane (TAP) block via lateral approachExperimentalThis group receives a Transversus abdominis plane (TAP) block via lateral approach
Receives: Procedure: TAP block via lateral approach
Transversus abdominis plane (TAP) block via posterior approachExperimentalThis group receives a Transversus abdominis plane (TAP) block via posterior approach
Receives: Procedure: TAP block via posterior approach
Control groupNo interventionThe control group receives no TAP block.

What is being measured

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

  1. Identification rate of the correct transverse abdominis plane block

    Identification rate of the correct transverse abdominis plane block by ultrasound as assessed by a five-point-scale which can be found as supplement (very good -good - acceptable -poor - very poor)

    Measured: immediately after the surgery

Secondary outcomes (10)
  1. Total morphine consumption

    Total morphine consumption by PCIA < 12 hours after the end of surgery

    Measured: 12 hours after surgery

  2. Patient recruitment rate

    ratio of patients giving informed consent to the number of eligible patients who were approached to participate

    Measured: through study completion, an average of 1 year

  3. Adherence rate to protocol

    number of patients who completed correct follow-up until 12h after surgery

    Measured: 12 hours after surgery

  4. total operation room time

    evaluation of the total operation room time

    Measured: during the surgery

  5. Assessment of the number of patients with local anesthestia systemic toxicity (LAST)

    Assessment of the number of patients with local anesthestia systemic toxicity (LAST) at the postoperative care unit (PACU): perioral numbness, metallic taste, tinnitus, convulsion, bradycardia < 40 beats per minute. This evaluation will be performed by a physician who will examine the patients for these symptoms

    Measured: during the stay at the PACU

  6. Number of patients in need of additional analgesic drugs at PACU

    Number of patients in need of additional analgesic drugs at PACU such as morphine or clonidine

    Measured: during the stay at the PACU

  7. Incision region pain scores

    evaluation of the Incision region pain scores with an 11 point numerical scale (NRS) with 0 indicating no pain and 10 indicating worst imaginable pain

    Measured: at baseline and at 4, 8, 12 and 24 hours after surgery

  8. Lumbar back pain scores

    evaluation of the lumbar back pain scores with an 11 point numerical scale (NRS) with 0 indicating no pain and 10 indicating worst imaginable pain

    Measured: at baseline and at 4, 8, 12 and 24 hours after surgery

  9. time to first mobilisation

    evaluation of time to first mobilisation

    Measured: immediately after the surgery until postoperative day 3

  10. quality of recovery

    evaluation of the Quality of recovery measured by the Quality-of-Recovery-40 (QoR 40) scale on postoperative day 3

    Measured: postoperative day 3

Timeline

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

  1. First posted11 Aug 2022
  2. Study start2 Sep 2022
  3. Primary completion23 Sep 2024
  4. Study completion23 Sep 2024

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05497908
Sponsor's protocol ID
f/2022/050
Status last verified
Sep 2024
First submitted
28 Jul 2022
Last updated
27 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TAP block via lateral approach and TAP block via posterior approach in people with Pain, Postoperative, run by Jessa Hospital at 1 site in Belgium.

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 7 inclusion and 5 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 27 Sep 2024. 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 Belgium. 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?

Identification rate of the correct transverse abdominis plane block (time frame: immediately after the surgery). 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 27 Sep 2024.

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