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.
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.
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.
- Conditions
- Pain, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| Transversus abdominis plane (TAP) block via lateral approach | Experimental | This 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 approach | Experimental | This group receives a Transversus abdominis plane (TAP) block via posterior approach Receives: Procedure: TAP block via posterior approach |
| Control group | No intervention | The control group receives no TAP block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Total morphine consumption
Total morphine consumption by PCIA < 12 hours after the end of surgery
Measured: 12 hours after surgery
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
Adherence rate to protocol
number of patients who completed correct follow-up until 12h after surgery
Measured: 12 hours after surgery
total operation room time
evaluation of the total operation room time
Measured: during the surgery
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
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
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
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
time to first mobilisation
evaluation of time to first mobilisation
Measured: immediately after the surgery until postoperative day 3
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.
- First posted11 Aug 2022
- Study start2 Sep 2022
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transverse Abdominis Plane (TAP) Block in EXtreme Lateral Interbody Fusion (XLIF) Surgery: a Pilot Feasibility Trial
- ClinicalTrials.gov ID
- NCT05497908
- Acronym / sponsor ID
- f/2022/050
- Conditions
- Pain, Postoperative
- Keywords
- eXtreme Lateral Interbody Fusion (XLIF) surgery, transversus abdominis plane (TAP) block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 11 Aug 2022 (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.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transversus abdominis plane (TAP) block via lateral approach | Experimental | Procedure: TAP block via lateral approachThis group receives a Transversus abdominis plane (TAP) block via lateral approach |
| Transversus abdominis plane (TAP) block via posterior approach | Experimental | Procedure: TAP block via posterior approachThis group receives a Transversus abdominis plane (TAP) block via posterior approach |
| Control group | No intervention | –The control group receives no TAP block. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
Key exclusion criteria (5 listed)
- - Refusal to participate
- Chronic strong opioid use (WHO analgesic ladder step 3)
- Allergy to local anesthetics
- Antecedents of lumbar back surgery
- Pregnancy
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 via lateral approachTAP block via lateral approach | Procedure or surgery | Transversus abdominis plane (TAP) block via lateral approach |
| TAP block via posterior approachTAP block via posterior approach | Procedure or surgery | Transversus abdominis plane (TAP) block via posterior approach |
Primary outcome
Identification rate of the correct transverse abdominis plane block
Time frame: immediately after the surgery
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)
10 secondary outcomes
Total morphine consumption
Time frame: 12 hours after surgery
Patient recruitment rate
Time frame: through study completion, an average of 1 year
Adherence rate to protocol
Time frame: 12 hours after surgery
total operation room time
Time frame: during the surgery
Assessment of the number of patients with local anesthestia systemic toxicity (LAST)
Time frame: during the stay at the PACU
Number of patients in need of additional analgesic drugs at PACU
Time frame: during the stay at the PACU
Incision region pain scores
Time frame: at baseline and at 4, 8, 12 and 24 hours after surgery
Lumbar back pain scores
Time frame: at baseline and at 4, 8, 12 and 24 hours after surgery
time to first mobilisation
Time frame: immediately after the surgery until postoperative day 3
quality of recovery
Time frame: postoperative day 3
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 27 Sep 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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.