Erector Spinae Plane Block Versus Intercostal for VATS

NCT03902782 | Completed DMC

• 1 other identifier: 2020-5553
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Lung Cancer; Lung Diseases

Outcome Measures

Primary Outcomes (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 at 24 hours postopertively

Secondary Outcomes (12)

• Efficacy of ESP block versus Intercostal nerve block in decreasing pain intensity at rest: Numerical Rating Scale (NRS)

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

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

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

• Change in pulmonary function

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

• Total opioid consumption

  48 hours post operatively

• Ipsilateral shoulder pain scores

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

Study Arms (2)

ESP block

EXPERIMENTAL

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.

Procedure: ESP block; Procedure: Sham Intercostal block; Drug: Bupivacaine-epinephrine; Drug: Dexamethasone injection; Drug: Normal saline

ESP sham block

SHAM COMPARATOR

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 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.

Procedure: Intercostal block; Procedure: Sham ESP block; Drug: Bupivacaine-epinephrine; Drug: Dexamethasone injection; Drug: Normal saline

Interventions

ESP block PROCEDURE

ESP with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg. Sham intercostal block with 20 ml Normal Saline

ESP block

Intercostal block PROCEDURE

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

ESP sham block

Sham ESP block PROCEDURE

As described earlier

ESP sham block

Sham Intercostal block PROCEDURE

As described earlier

ESP block

Bupivacaine-epinephrine DRUG

As described earlier

ESP block; ESP sham block

Dexamethasone injection DRUG

As described earlier

ESP block; ESP sham block

Normal saline DRUG

As described earlier

ESP block; ESP sham block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3A 1A1, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases

Interventions

Calcium Dobesilate; Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of anesthetsia

Study Record Dates

• First Submitted: April 1, 2019
• First Posted: April 4, 2019
• Study Start: June 26, 2019
• Primary Completion: June 20, 2021
• Study Completion: June 20, 2021
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

CA (1)