Feasibility of TAP for XLIF Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497908
• Other study ID #: f/2022/050
• Status: Recruiting
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: September 2023
• Source: Jessa Hospital
• Contact: Bjorn Stessel, MD, Phd
• Phone: 003211339856
• Email: bjorn.stessel[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• - Refusal to participate

• Chronic strong opioid use (WHO analgesic ladder step 3)

• Allergy to local anesthetics

• Antecedents of lumbar back surgery

• Pregnancy

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• TAP block via lateral approach
TAP block via lateral approach
• TAP block via posterior approach
TAP block via posterior approach

Locations

Country	Name	City	State
Belgium	Jessa Hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	immediately after the surgery
Secondary	Total morphine consumption	Total morphine consumption by PCIA < 12 hours after the end of surgery	12 hours after surgery
Secondary	Patient recruitment rate	ratio of patients giving informed consent to the number of eligible patients who were approached to participate	through study completion, an average of 1 year
Secondary	Adherence rate to protocol	number of patients who completed correct follow-up until 12h after surgery	12 hours after surgery
Secondary	total operation room time	evaluation of the total operation room time	during the surgery
Secondary	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	during the stay at the PACU
Secondary	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	during the stay at the PACU
Secondary	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	at baseline and at 4, 8, 12 and 24 hours after surgery
Secondary	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	at baseline and at 4, 8, 12 and 24 hours after surgery
Secondary	time to first mobilisation	evaluation of time to first mobilisation	immediately after the surgery until postoperative day 3
Secondary	quality of recovery	evaluation of the Quality of recovery measured by the Quality-of-Recovery-40 (QoR 40) scale on postoperative day 3	postoperative day 3