LUMBES: Lumbar Erector Spinae Plane Block for Back Surgery

Sponsor

Dr M. B. Breebaart (Other)

Overall Status

Recruiting

CT.gov ID

NCT03825198

Collaborator

(none)

Enrollment

Locations

Arms

52.5

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Title:

A prospective randomized double blind trial of the efficacy of a bilateral lumbar erector spinae block on the 24 h morphine consumption after posterior lumbar interbody fusion surgery.

Objectives:

The primary objective is to study the influence of a bilateral erector spinae block on 24h morphine consumption.

Endpoint:

The primary endpoint is the 24 h morphine consumption in mg. Secondary endpoints are intraoperative sufentanil requirement, total morphine during first 72 postoperative hours, NRS pain scores in rest and defined movement (moving to chair) at regular time intervals and Quality of Recovery 40 score (QoR-40) at fixed time intervals day 1 and 3 postoperatively

Population:

Patients undergoing posterior lumbar interbody fusion ranging 1 - 3 levels Phase 3

Number of sites Enrolling participants:

University Hospital Antwerp &AZ KLINA Brasschaat

Description of study agent:

Bilateral erector spinae block: each block contains 20 ml levobupivacaine 0.25% + 5 mcg/ml epinephrine Study duration Until the required study population is met Participant duration 72 hours

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative Anaesthesia Surgery Nerve Block Anesthesia, Local Back Pain Spinal Fusion	Procedure: Erector spinae plane block Drug: Levobupivacaine 0,25% Procedure: spine fusion Drug: NaCL 0,9% Drug: Sufentanil Drug: propofol Drug: Rocuronium Bromide Drug: sevoflurane Drug: paracetamol Drug: Ketorolac Drug: morphine pca Drug: Dexamethasone Drug: Morphine	Phase 3

Detailed Description

In this prospective randomized double blind placebo controlled clinical trial we would like to assess the efficacy of a bilateral lumbar erector spinae block on the 24h morphine consumption after posterior lumbar interbody fusion surgery. Patients scheduled for 1-2 level PLIF surgery will be recruited in AZ KLINA in Brasschaat and the University Hospital Antwerp in Edegem. The study contains two arms. Subjects will be randomly allocated to an erector spinae block group or the sham block group (placebo).

Stratified randomization will be done according to gender, levels of surgery and site online with Q minim.The study medication will be prepared in identical premade syringes and numbered according to a computer generated block randomization list (1:1 ratio ESB:sham). Subjects will be assigned consecutive numbers upon inclusion to the study and receive the study medication from the corresponding numbered syringes. The study medication in syringes for injection will be prepared by an anesthesiologist neither involved in the study nor in the care of the patient, before handing it over to the investigators. The ESB-group will receive 20 ml Chirocaine 0,25%. The sham block group medication will receive 20 ml Nacl0,9%. The levobupivacaine and saline 0.9% are identical in appearance. All investigators, staff and patients will be blinded to the treatment groups. Epinephrine is added to the placebo block in order to prevent unblinding by increased heart rate or blood pressure. Unmasking will not occur until statistical analysis is complete.

Patients in the erector spinae block group will receive a bilateral ESB block with an injectate containing 20 ml of levobupivacaine 0.25% in each puncture. Patients allocated to the sham group receive a bilateral ESB block with each injectate containing 20 mL of NaCl 0.9% . The blocks will be performed by experts in the field of ultrasound guided locoregional anaesthesia namely dr D. van Aken, dr L. Sermeus and dr M.B. Breebaart who are also teachers for the BARA (Belgian Association of Regional Anaesthesia). The blocks will be performed preoperatively in a separate block room with ultrasound after placement of an iv line and application of standard monitoring (ECG, NIBP, saturation). The blocks will be placed as described by Chin et al. modified for lumbar level.8 First, the patient will be placed 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 the vertebrae at the (mid) level of surgery, the erector spinae muscle and the psoas muscle are identified. In case of two level surgery the transverse process of the upper level will be considered as the preferred target. Depending on the depth a 5 or 8 cm 22 G ultrasound needle (Pajunk) 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, 20 ml of the study medication will be injected behind the erector spinae muscle. The same procedure will be repeated on the contralateral side.

General anesthesia will then be induced in a standardized way with propofol 2-3mg/kg, sufentanil 15mcg and rocuronium 0.5mg/kg. After tracheal intubation anesthesia will be maintained with sevoflurane and intraoperative analgesia with sufentanil. The dosages of these agents will be determined at the discretion of the anesthesiologist. At the end of surgery patients will receive acetaminophen 1g IV, ketorolac (Taradyl, CSP Benelux) 0.5 mg/kg (max. 30 mg) IV and a morphine loading dose (0.1 mg/kg) IV to manage postoperative pain. Patients will be extubated in the operating theatre and admitted to the post anesthesia care unit (PACU). Postoperative pain in the PACU and on the ward will be treated with acetaminophen 1g IV round the clock (4 times daily) and by a patient controlled intravenous analgesia pump (PCIA) with morphine at a concentration of 1 mg/ml and dehydrobenzperidol (DHBP) 0.05 mg/ml. The PCIA will be set using a standardised protocol: no background administration of morphine, a bolus dose of 1.5 mL morphine with a lock-out interval of 8 minutes and an hourly limit of 7.5 mg. If pain management on the PACU is inadequate (NRS > 3) additional boli of 1 mg morphine IV will be administered with the total additional dose of morphine limited to 0.15mg/kg morphine. In case NRS is still > 3 an IV ketamine (Ketalar, Pfizer) bolus (0.2 mg/kg) will be given. All patients receive dexamethasone 5mg IV as postoperative nausea and vomiting (PONV) prophylaxis. If needed, this will be supplemented by ondansetron 4mg IV and if still insufficient with alizapride 50mg IV. Other study endpoints will be retrieved from the patient data management systems

The morphine consumption during the first 24 hours postoperatively will be extracted out of the PCIA pump. The total morphine dose requirement during the first 72 postoperative hours will also be extracted out of the PCIA pump. Pain scores at rest will be assessed with the numeric rating scale (NRS, 0=no pain 10= worst imaginable pain) and tested at regular time intervals: at the time of inclusion, at the PACU (T0 = arrival at Post Anesthesia Care Unit, T+15min, T+30min) and ward (twice daily- morning and evening until postoperative day 3) Pain scores during defined movement (first moving to chair and upright sitting) will be examined. Time to first mobilization in chair (in hours since T0) and time to first walk of twenty meters (in hours since T0) will be noted in the patients study diary. The quality of recovery 40 score (QoR-40) will be calculated out of a series of questions patients are required to answer at day 1 and 3 postoperatively. The QoR-40 is a widely used and extensively validated measure of quality of recovery. It is a 40-item questionnaire on quality of recovery from anesthesia, that has been shown to measure health status after surgery.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blind randomiseddouble blind randomised

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The medication for the sham block with NaCl or the local anaesthetic will be prepared by an independent medical caregiver who has no connection with the patient. The anaesthetics performing the block, the patient and the observation nurses/doctors collecting the data are masked. The solutions used are not distinguishable from each other.

Primary Purpose:

Treatment

Official Title:

A Prospective Randomized Double Blind Trial of the Efficacy of a Bilateral Lumbar Erector Spinae Block on the 24h Morphine Consumption After Posterior Lumbar Interbody Fusion Surgery.

Actual Study Start Date :

Aug 1, 2019

Anticipated Primary Completion Date :

Dec 15, 2023

Anticipated Study Completion Date :

Dec 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: ESB group Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane. Postoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.	Procedure: Erector spinae plane block Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle Other Names: Locoregional anaesthesia Drug: Levobupivacaine 0,25% 20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle Other Names: chirocaine Procedure: spine fusion fusion of lumbar vertebral body on 1 or two levels Drug: Sufentanil opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag) Other Names: sufenta Drug: propofol induction agent for general anaesthesia ( 2-3 mg/kg) Drug: Rocuronium Bromide muscle relaxant used during general anaesthesia ( 0,5 mg/kg) Other Names: sermon Drug: sevoflurane inhalation aesthetic used for the maintenance of general anaesthesia Drug: paracetamol postoperative drug for analgesia ( 1 gram 4/day) Drug: Ketorolac non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg) Drug: morphine pca postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml Other Names: patient controlled analgesia Drug: Dexamethasone drug given during general anaesthesia to prevent postoperative nausea Other Names: aacidexam Drug: Morphine loading dose morhine 0,1 mg/kg at the end of surgery
Sham Comparator: SHAM group Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.	Procedure: Erector spinae plane block Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle Other Names: Locoregional anaesthesia Procedure: spine fusion fusion of lumbar vertebral body on 1 or two levels Drug: NaCL 0,9% 20 ml solution used for the infiltration between the transverse process and th erector spinal muscle Drug: Sufentanil opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag) Other Names: sufenta Drug: propofol induction agent for general anaesthesia ( 2-3 mg/kg) Drug: Rocuronium Bromide muscle relaxant used during general anaesthesia ( 0,5 mg/kg) Other Names: sermon Drug: sevoflurane inhalation aesthetic used for the maintenance of general anaesthesia Drug: paracetamol postoperative drug for analgesia ( 1 gram 4/day) Drug: Ketorolac non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg) Drug: morphine pca postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml Other Names: patient controlled analgesia Drug: Dexamethasone drug given during general anaesthesia to prevent postoperative nausea Other Names: aacidexam Drug: Morphine loading dose morhine 0,1 mg/kg at the end of surgery

Arm

Intervention/Treatment

Active Comparator: ESB group

Erector Spinae plane block with 20 ml levobupivacaine 0,25% on each side. General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane. Postoperative analgesia with Ketorolac (0,5 mg/kg), paracetamol 1000 mg (4 times/ day) and Morphine PCA. Dexamethasone is administered for the prevention of nausea.

Procedure: Erector spinae plane block

Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle

Other Names:

Locoregional anaesthesia

Drug: Levobupivacaine 0,25%

20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle

Other Names:

chirocaine

Procedure: spine fusion

fusion of lumbar vertebral body on 1 or two levels

Drug: Sufentanil

opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)

Other Names:

sufenta

Drug: propofol

induction agent for general anaesthesia ( 2-3 mg/kg)

Drug: Rocuronium Bromide

muscle relaxant used during general anaesthesia ( 0,5 mg/kg)

Other Names:

sermon

Drug: sevoflurane

inhalation aesthetic used for the maintenance of general anaesthesia

Drug: paracetamol

postoperative drug for analgesia ( 1 gram 4/day)

Drug: Ketorolac

non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)

Drug: morphine pca

postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml

Other Names:

patient controlled analgesia

Drug: Dexamethasone

drug given during general anaesthesia to prevent postoperative nausea

Other Names:

aacidexam

Drug: Morphine

loading dose morhine 0,1 mg/kg at the end of surgery

Sham Comparator: SHAM group

Erector Spinae plane block with 20 ml NaCl 0,9% on each side General anesthesia with 15 mcg sufentanil, 2-3 mg/kg propofol and 0,5 mg/kg Rocuronium Bromide during spine fusion surgery (1 or two intervertebral levels). Maintainance of general anesthesia with sevoflurane.Postoperative analgesia with Ketorolac (0,5 mg/kg, paracetamol 1000 mg 4times/ day and Morphne PCA .Dexamethasone is administered for the prevention of nausea.

Procedure: Erector spinae plane block

Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle

Other Names:

Locoregional anaesthesia

Procedure: spine fusion

fusion of lumbar vertebral body on 1 or two levels

Drug: NaCL 0,9%

20 ml solution used for the infiltration between the transverse process and th erector spinal muscle

Drug: Sufentanil

opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)

Other Names:

sufenta

Drug: propofol

induction agent for general anaesthesia ( 2-3 mg/kg)

Drug: Rocuronium Bromide

muscle relaxant used during general anaesthesia ( 0,5 mg/kg)

Other Names:

sermon

Drug: sevoflurane

inhalation aesthetic used for the maintenance of general anaesthesia

Drug: paracetamol

postoperative drug for analgesia ( 1 gram 4/day)

Drug: Ketorolac

non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)

Drug: morphine pca

postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml

Other Names:

patient controlled analgesia

Drug: Dexamethasone

drug given during general anaesthesia to prevent postoperative nausea

Other Names:

aacidexam

Drug: Morphine

loading dose morhine 0,1 mg/kg at the end of surgery

Outcome Measures

Primary Outcome Measures

24 hour morphine consumption [24 hours]
total milligrams (0-150) of morphine used in the first 24 hours after surgery, extracted out of the pca pump data.

Secondary Outcome Measures

Intraoperative sufentanyl requirement ( [2-5 hours]
total Intravenous administered sufentanyl in micrograms during surgery(10-100)
Morphine consumption 72 hours [72 hours]
total milligrams of morphine used in 72 hours after surgery (0-450), extracted out of the pca pump data
NRS pain scores [at regular intervals and defined movement until 72 hours after surgery]
Numeric rating scale pain score (in numbers) and rest (0= no pain10 =worst thinkable pain)
Quality of recovery score (QoR-40) [day 1 and day 3 postoperatively]
score in numbers of mental and psychological well being scored by list of questions (minimal score 20-maximum score 200). A high score indicates a better/faster recovery, and is inversely correlated with hospital stay
time to mobilisation to chair [8-72 hours]
movements (mobilisation to chair) in hours after surgery
time to 20 meter walking [8-72 hours]
movement 20 meter walking in hours after surgery

Other Outcome Measures

expected preoperative pain score (NRs° [before surgery ( moment of inclusion)]
Numeric rating scale pain score (in numbers). pain that people expect before they have surgery.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

- Patients scheduled for 1-2 level posterior lumbar interfusion surgery in AZ KLINA Hospital or University of Antwerp Hospital (UZA) after approval of Ethical Committee until all required patients are included
American Society of Anesthesiologist (ASA) score of 1 - 3
Age 18 - 75 year
Normal liver and renal function

Exclusion Criteria:

Age <18 years or mentally incompetent
BMI < 16 or BMI > 35
Allergy to one or more substances of the study medication (= levobupivacaine, dexamethasone, propofol, sufentanil, rocuronium, ketorolac, morphine, ketamine, DHBP, ondansetron, alizapride)
Chronic strong opioid use (>3 intakes per week)