Evaluate the non-inferiority of the ESP-block compared to the TEA in VATS lobectomy or wedge resection.
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome of this study is the QoR15 on POD 0,1 and 2
Secondary outcome
Secondary endpoints are Visual Analog Scales (VAS) score on POD 0,1 and 2
(assessed at rest and when moving (coughing) in the morning and in the
evening), Length of hospital stay (LOS), failure of analgesic technique
(defined as catheter failure, need for specialist intervention and/ or need for
rescue medication), the postoperative morphine-equivalent consumption on POD
0,1 and 2, itching, nausea and vomiting, the total operative time (recorded as
total time spent in the operating room, anesthetic time, surgical time),
complications related to surgery (e.g. conversion to open procedure),
perioperative hypotension (requiring prolonged use of vasopressors)
complications related to pain treatment (e.g. epidural hematoma or local
anesthetic toxicity) duration of bladder catheterization, first mobilization
(to chair and > 20 meters)
Background summary
Regional anesthesia numbs only the area of the body that requires surgery by
injecting local anesthetic near a cluster of nerves. It is added to the general
anesthesia regimen to obtain improved pain relief during and after surgery. For
video assisted thoracoscopic surgery (VATS), a thoracic epidural (TEA) is used
in the Catharina Hospital Eindhoven and Maasstad Hospital Rotterdam as regional
anesthesia technique. A thoracic epidural block interrupts the sensation by
injecting local anesthetics near the spinal canal. Recently, the Erector Spinae
Plane (ESP) block has been introduced by Forero and colleagues as a practical
alternative to the thoracic epidural block. It interrupts the sensation by
injecting local anesthetics in between the muscular layers of the thoracic wall
and has been successfully reported as regional anesthesia technique for VATS
surgery in case series. Injecting local anesthetic in between muscular layers
is easier and safer than near the spinal canal.
Study objective
Evaluate the non-inferiority of the ESP-block compared to the TEA in VATS
lobectomy or wedge resection.
Study design
This is an investigator-initiated prospective randomized open label
non-inferiority trial comparing the TEA with ESP as regional anesthesia
technique for VATS-surgery. The study will be performed in accordance with the
Declaration of Helsinki (Fortaleza, Brazil, October 2013). A total of 90
patients are being randomly allocated to ESP(study group) or TEA (control
group). This study is set up as a non-inferiority trial as we do not debate the
analgesic effectiveness of a good working TEA. Furthermore, superiority is not
considered necessary because of the previously mentioned advantages of ESP. It
is not possible to create a double-blinded study protocol given these two
visually different regional pain treatment modalities hence the open-label
study design.
Patients will be followed until 48 hours after surgery or until discharge from
the hospital.
Intervention
- Intervention arm: ESP
The ESP-block will be placed as described by Chin et al. First, the patient
will be installed in the lateral or sitting position. A curve array probe or a
high frequency linear probe, depending on the BMI of the patient, will be
placed in a longitudinal position 2-3 cm lateral of the vertebral column. The
transverse processes of T5, the erector spinae muscle and the psoas muscle are
identified. An epidural needle will be inserted with an in plane technique in a
cephalad to caudad direction until bone contact with the top of the transverse
process is reached. After slight retraction of the needle, hydrodissection with
normal saline will allow to visualize the correct plane for injection. Then
ropivacaine will. be injected followed by the insertion of the catheter 5cm
beyond the needle tip. Patients over 70kg will receive 200mg ropivacaine
(40ml), patients 50_70kg will receive 150mg ropivacaine (40ml) and patients
under 50kg will receive ropivacaine 3mg/kg (40ml). During surgery, the catheter
is not used. At the end of the surgery, 10ml op bupivacaine 0.125% will be
injected through the catheter followed by a continuous infusion of 5ml
bupivacaine 0.125%/hour and bolus option of 10ml bupivacaine 0.125% every 3
hours. When ESB does not provide adequate pain relief, minor adjustments or a
manual top-up are allowed.
- Control arm: TEA
Preoperatively, an anesthesiologist places an epidural catheter between the
T5-T7 level at the discretion of the anesthesiologist. The epidural catheter
is managed following in house protocol. When CEA does not provide adequate pain
relief, minor adjustments or a manual top-up are allowed.
Study burden and risks
* Both the study and the control group will receive a regional anesthesia
technique using local anesthetics. The potential risks of a regional anesthesia
technique are:
-Discomfort during puncture
-Allergy for the desinfectant or levobupivacaine
-Infection at the skin, needle trajectory or point of injection. The clinical
presentation can be variable, like redness or in extreme cases an intramuscular
abscess.
-Bleeding at the skin, needle trajectory or point of injection.
-Neural damage: The risk of neural damage is higher for the control group as
the needle puncture is close to the spinal canal and nerve roots. For patients
in the study group risk of neural damage is rare since the target of the
puncture is a muscular plane and not the nerve root or nerve ramus itself.
-Local anesthetic systemic toxicity (LAST): A substantial amount of local
anesthetic is used in the study group. This may results in a higher risk for
LAST as is with any existing plane block. LAST can immediately be treated with
intralipid.
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Michelangelolaan 2
Eindhoven 5623 EJ
NL
Listed location countries
Age
Inclusion criteria
(1) Age between 18 and 75 years,
(2) BMI between 18 and 30kg/m2,
(3) scheduled for elective VATS surgery, and
(4) written informed consent.
Exclusion criteria
(1) ASA status***4
(2) chronic opioid use (> 3 months of strong opioids, weak opioids such as
tramadol are allowed)
(3) renal or liver failure inhibiting the systematic use of paracetamol and/or
NSAIDs
(4) contraindication for epidural analgesia (e.g. INR or platelets according to
local protocol, local infection at the surgery site or puncture site)
(5) allergy to study medication
(6) pregnancy
(7) cognitive impairment
(8) insufficient comprehension of the Dutch QoR-15 questionnaire.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| Other | Nederlands Trial register nr NL6433 |
| CCMO | NL65158.100.18 |
| OMON | NL-OMON22453 |