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Lung CancerNCT03902782

Erector Spinae Plane Block Versus Intercostal for VATS

A study testing ESP block, Intercostal block and Bupivacaine-epinephrine in people with Lung Cancer and Lung Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al. Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lung Cancer, Lung Diseases
What is being tested?
ESP block, Intercostal block and Bupivacaine-epinephrine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteCanada
Study dates
26 Jun 2019to 20 Jun 2021
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female patients
  • age between 18 to 80 years old
  • ASA 1-3
  • scheduled for VATS
  • informed consent explained and signed

Who cannot join

  • Patients < 18 years old, > 80 years old
  • ASA physical status > 3
  • morbid obesity (BMI >40)
  • previous cardiac surgery or ipsilateral thoracic surgery
  • neuropsychiatric diseases
  • serum albumin < 35 g/L
Show all 18Show fewer
  • cardiac, renal (creatinine > 200mmol/l) or hepatic failure (aspartate amino transferase, alanine amino transferase > 50 % over the normal range)
  • anemia (hematocrit <30%)
  • organ transplant
  • allergy to analgesics or local anesthetics or other medications used in the study
  • abuse of opioids or sedatives
  • contraindication to receive regional anesthesia (e.g. coagulation defect)
  • patients who could not understand the VAS pain-scoring system
  • patient refusal to follow participation
  • intraoperative conversion to open thoracotomy
  • revision or re-operation or complication of surgery during the follow-up time
  • post operative mechanical ventilation
  • intolerance or allergy to any prescribed medication

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Montreal General Hospital

    Montreal, Quebec, H3A 1A1

Other trials in Canada

About this study

Official title: Ultrasound-Guided Erector Spinae Plane Block Versus Intercostal Nerve Block For Postoperative Pain Control in Video-Assisted Thoracoscopic Surgery: A Prospective, Double Blind Randomized Controlled Trial

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al. Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures. Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

Read the detailed description

In recent years, Video-Assisted Thoracic surgeries (VATS) has become the preferred approach for thoracic surgeries over thoracotomies, due to its clear advantages, such as improved pulmonary function, rapid recovery and reduced pain scores postoperatively. Although pain is reduced in VATS when compared to conventional thoracotomies, patients still experience moderate to severe pain, mainly due to intercostal nerve damage by ports and drains, as well as the surgical resection itself. Adequate pain relief leads to earlier and better mobilization, improves respiratory functions, and decreases global stress response. In addition, it helps in reducing the chances of developing chronic postoperative pain.

Epidural blockade has been recognized as the gold standard for analgesia in thoracic surgeries, with paravertebral blocks (PVB) replacing that standard in VATS procedures, due it's less deleterious adverse effects. Nevertheless, paravertebral blockade still poses some adverse effects such as pneumothorax and the risk of an epidural blockade. Moreover, it might prove difficult to perform in the untrained hand. Thus, a simpler blockade is warranted in patients undergoing VATS.

Proper pain relief is critical in the early postoperative period in VATS surgery, to allow early discharge of patients according to the clinical pathway milestones. The excessive consumption of opioids to achieve this goal on the other hand, may produce complications and side effects not compatible with the early discharge plan.

The Erector Spinae Plane (ESP) block is a new interfascial regional anesthesia technique recently described by Forero et al . It consists of injecting 20 ml of local anesthetic (ie.: ropivacaine 0.5%), under ultrasound guidance, at the level of the T5 transverse process in the tissue plane deep to the erector spinae muscle. A study on the ESP block was conducted on fresh human cadavers; dye mixture was injected deep to erector spinae muscle, and the spread showed to be cranio-caudal from C7 to T8, lateral spread extended to the tips of the transverse processes at all levels, penetration of the dye was beyond the costotransverse junction and anteriorly into the inter transverse spaces. In addition, there was evidence of dye penetration deep to the intercostal muscles and into the immediate vicinity of the ventral and dorsal rami of the spinal nerve roots. The authors discussed the most significant advantage of the ESP block is its simplicity and safety. The sonoanatomy is easily recognizable, there are no structures at risk of needle injury in the immediate surroundings (lower risk of nerve damage and pneumothorax), and is probably safer for patients with coagulation disorders. The technique also allows the insertion of an indwelling catheter to extend the duration of analgesia as needed.

Currently the literature shows the ESP block being used for analgesia after thoracic surgery, breast surgery, abdominal surgery (visceral abdominal analgesia in bariatric surgery, ventral hernia repair, cholecystectomy), thoracic vertebral surgery and for pain relief in rib fractures.

Taking in consideration the excellent clinical experience, but the lack of strong and high-quality evidence, supporting the use of ESP block for pain management in patients undergoing VATS procedures, there is a specific interest to develop a prospective study. Comparing the effect of the current pain relief strategy at the MGH (intercostal nerve block by the surgeon at the end of the procedure ) versus ESP block after VATS, seems warranted to improve current clinical results.

In this randomized controlled trial, the investigator hypothesize that a single injection ESP block, would provide an effective post operative pain relief, superior to an intercostal nerve block, in patients undergoing VATS procedures.

The study will be conducted at the Montreal General Hospital, one hundred patients; ASA I-III male and female patients aged between 18 to 80 years old, who are scheduled for Video assisted thoracic surgery. Patients will be recruited before surgery. Informed consent will be obtained by a Research Assistant.

Patients will be prospectively randomized in a double blind fashion, using a computer-generated number placed in a sealed brown envelope, into either group 1, receiving ESP block, or group 2, receiving sham ESP block.

In group 1, patients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.

In group 2, patients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.

All medications will be prepared by a research assistant not assigned to the case, and not involved in the follow up assessment. Two 20 ml syringes will be prepared under sterile precautions, one containing Bupivacaine 0.25% with epinephrine 5 µg/ml and 10 mg dexamethasone, and the other containing 0.9% normal saline. Syringes will be labeled as "ESP" and "intercostal" according to the randomization. The evaluator in the postoperative period, the anesthesiologist, the patient and the surgeon will be blinded to the group randomization.

General anesthesia will be induced with propofol 1.5-2 mg/kg and fentanyl 2 mcg/kg, as well as rocuronium 0.6 mg/kg to facilitate tracheal intubation with a double lumen tube (DLT). A 3.2 mm fiberoptic bronchoscope will be used to confirm correct placement of the DLT, to allow one lung ventilation intraoperatively. Anesthesia will be maintained with sevofluorane or desflourane according to the anesthesiologist's preference.

For intra-operative analgesic requirements, Specific instructions will be handed to each anesthetist to administer fentanyl 25 mcg increments every 5 minutes in the following scenarios:

Elevation in the heart rate of more than 20% of baseline values. Elevation in blood pressure of more than 20% of baseline values.

Patients will receive Ondansetron 4mg prior to extubation. Post anesthetic care and medications will include.

Acetaminophen 975mg, PO or PR, Q6H Celecoxib 100mg, PO, BID for 5 days Ondansetron 4mg, PO or IV, Q8H, PRN (for nausea or vomiting) Nalbuphine 2.5 mg, IV, diluted PRN (for pruritus) Polyethylene glycol 17gr, PO, Day, PRN (for constipation)

All patients enrolled will be provided with a Patient Controlled Analgesia (PCA) pump for first 24 hours after the surgery. The pump will be programmed to deliver Morphine sulfate 1mg, lockout time 7 min, without a continuous infusion rate, capable to be increased to 1.5mg if pain VAS≥7 with the absence of sign or symptoms of toxicity. Hydromorphone will be used in case of Morphine allergy. Patients will be clearly instructed to trigger the PCA Only if they perceive pain as >4/10 If the PCA IV line gets lost with failure to obtain a new one, in patients with VSA>4, a rescue dose 3-5mg morphine SC Q4H PRN will be considered. The time and dose of rescue medication will be recorded.

The Standard Institutional Postoperative Clinical Pathway will be followed in both groups, except for the use of PCA.

Being tested
ESP block, Intercostal block, Sham ESP block, Sham Intercostal block, Bupivacaine-epinephrine
Medical subject headings
Lung Neoplasms, Lung Diseases

What participants receive

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

  • ESP blockProcedure or surgery

    ESP with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

    Sham intercostal block with 20 ml Normal Saline

  • Intercostal blockProcedure or surgery

    Intercostal block with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.

    Sham ESP with 20 ml Normal Saline

  • Sham ESP blockProcedure or surgery

    As described earlier

  • Sham Intercostal blockProcedure or surgery

    As described earlier

  • Bupivacaine-epinephrineDrug

    As described earlier

  • Dexamethasone injectionDrug

    As described earlier

  • Normal salineDrug

    As described earlier

Study groups in NCT03902782
Study groupRoleWhat they receive
ESP blockExperimentalpatients will receive an ultrasound guided ESP block (technique as described by Forero et al) under strict sterile conditions in the operating room area. After identifying the T5 transverse process (TP) and after infiltration of lidocaine 2% subcutaneously. A 22g 100mm block needle will be advanced under vision, in a cephalad to caudad direction, until the tip contacts the T5 TP. 20 ml of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be injected under the erector spinae muscle. A visible separation of the erector spinae muscle from the TP will be the sign of a successful block. A 20 ml syringe of Normal Saline will be given to the surgeon (unaware of the content) at the end of the surgery, for the intercostal nerve block as per standard present technique.
Receives: Procedure: ESP block; Procedure: Sham Intercostal block; Drug: Bupivacaine-epinephrine; Drug: Dexamethasone injection; Drug: Normal saline
ESP sham blockSham comparatorpatients will receive an ultrasound guided sham ESP block under strict sterile conditions in the operating room area as described above. 20 ml of Normal Saline will be injected under the erector spinae muscle. A 20 ml syringe of 0.25% bupivacaine with 5 mcg/ml of epinephrine and 10 mg dexamethasone will be given to the surgeon (blinded to the content) at the end of the surgery for the intercostal nerve block.
Receives: Procedure: Intercostal block; Procedure: Sham ESP block; Drug: Bupivacaine-epinephrine; Drug: Dexamethasone injection; Drug: Normal saline

What is being measured

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

  1. Efficacy of ESP block versus Intercostal nerve block in decreasing opioid consumption

    measured by total intravenous morphine consumption at 24 hours postopertively. A 25% reduction in morphine consumption would be considered statistically significant.

    Measured: Measured at 24 hours postopertively

Secondary outcomes (12)
  1. Efficacy of ESP block versus Intercostal nerve block in decreasing pain intensity at rest: Numerical Rating Scale (NRS)

    Pain levels will be assessed using the 10 points Numerical Rating Scale (NRS) where zero= no pain and 10= pain as bad as it can be. The NRS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels

    Measured: measured at post operative 2, 4, 12, 24 and 48 hours

  2. Efficacy of ESP block versus Intercostal nerve block in decreasing pain intensity upon mobilization: Numerical Rating Scale (NRS)

    Pain levels will be assessed using the 10 points Numerical Rating Scale (NRS) where zero= no pain and 10= pain as bad as it can be. The NRS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels

    Measured: measured at post operative 2, 4,12, 24 and 48 hours

  3. Change in pulmonary function

    This will be assessed using the incentive spirometer, which allows for crude measurement of inspired volumes

    Measured: pre-operatively and 2, 4, 12, 24 and 48 hours after the procedure

  4. Total opioid consumption

    In morphine equivalencies

    Measured: 48 hours post operatively

  5. Ipsilateral shoulder pain scores

    Pain levels will be assessed using the 10 points Numerical Rating Scale (NRS) where zero= no pain and 10= pain as bad as it can be. The NRS is a validated tool to measure pain and discomfort. It is sensitive to pharmacological and non-pharmacological interventions, that have an impact over the experience of pain, as well as it's high correlation with pain levels

    Measured: 2, 4, 12, 24 and 48 hours after the procedure

  6. Incidence of adverse events

    postoperative nausea and vomiting (PONV), hypotension, urinary retention (requiring placement of an indwelling or a temporary catheter), pruritis and oxygen requirements

    Measured: Over the first 48 hours

  7. Length of stay in the post anesthesia care unit (PACU)

    total time spent in the PACU until reaching PACU discharge criteria

    Measured: up to 24 hours

  8. Length of stay in the hospital

    total time spent in the hospital until reaching hospital discharge criteria

    Measured: up to 10 days

  9. Time to first mobilization to the chair

    Measured: Measured from the arrival time to PACU

  10. Time to first ambulation (walking) out of bed

    Measured: Measured from the arrival time to PACU

  11. Block performance time

    The time it takes to perform the ESP block

    Measured: Up to 40 minutes

  12. Block related adverse events

    Incidence of block related adverse events such as bleeding, pneumothorax and local anesthetic systemic toxicity

    Measured: First 4 hours postopertively

Timeline

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

  1. First posted4 Apr 2019
  2. Study start26 Jun 2019
  3. Primary completion20 Jun 2021
  4. Study completion20 Jun 2021

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902782
Sponsor's protocol ID
2020-5553
Status last verified
Mar 2024
First submitted
1 Apr 2019
Last updated
13 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing ESP block, Intercostal block and Bupivacaine-epinephrine in people with Lung Cancer and Lung Diseases, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.

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 5 inclusion and 18 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 13 Mar 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 Canada. 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. Some participants in this study may receive a placebo. 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?

Efficacy of ESP block versus Intercostal nerve block in decreasing opioid consumption (time frame: Measured at 24 hours postopertively). 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 13 Mar 2024.

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