Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery

Erector Spinae Plane Block for Video-assisted Thoracoscopic Surgery: a Randomized Controlled Trial

Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery that utilizes camera based scopes and specialized instruments through keyhole sized ports to remove lesions in the thoracic cavity. Despite reduced surgical trauma compared to the traditional thoracotomy approach, patients continued to experience moderate to severe postoperative pain. Pain medication such as opioids is commonly utilized for postoperative pain control but is associated with side effects. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery and decrease the risk of pulmonary complication. This study aims to investigate the analgesic effect of ESPB in managing pain following VATS.

Study Overview

• Status: Unknown
• Conditions: Analgesia; Thoracic Surgery; Peripheral Nerve Block
• Intervention / Treatment: Drug: Normal saline; Drug: Ropivacaine Injection [Naropin]

Detailed Description

VATS is a minimally invasive surgical technique to remove intrathoracic lesions. Using a camera based scope and specifically designed instruments, the surgery can be initiated with three "key-hole" sized incisions. At the end of the surgery, an incision is enlarged to allow removal of surgical specimen. Chest tubes are inserted at the end of procedure and sutured in between the ribs.

While acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. Source of pain may be from diaphragm irritation, surgical incisions and chest tubes. Because of its origin on the chest wall, pain from VATS worsens with breathing. When pain is poorly controlled, it will lead to a shallow breathing pattern called "splinting" and this can progress to respiratory distress or failure. Given the high incidence of smoking history in this patient population, many would have presented with poor baseline respiratory function. Therefore, it is important to provide good pain control to allow deep breathing and cough to reduce respiratory complications[1][2].

Despite the smaller incisions, the incidence of chronic post-surgical pain (CPSP) after VATS is surprisingly similar to thoracotomy. The mechanism may be due to nerve compression by the trocar, an instrument inserted between the ribs to allow smooth manipulation of camera and surgical instruments in the thoracic cavity. Additionally, poorly controlled acute pain has also been postulated to lead to the development of CPSP, further emphasizing the importance of good analgesia[1].

Many regional analgesia techniques have been tried to improve postoperative analgesia. Thoracic epidural analgesia (TEA) remains the gold standard of pain control after thoracic surgery. Although it provides superior analgesia, its use is hindered by the rare but serious complication of epidural hematoma and abscess which may cause paralysis. Further, pain from VATS tends to be short-lived (less than 24 hours), making the risk to benefit ratio less ideal for TEA. An alternative to TEA is paravertebral block (PVB). Compared to TEA, it causes less hypotension and hematoma or abscess at the paravertebral space may be less consequential. Nevertheless, PVB is a deep block and is technically demanding which limits its wide adoption[3].

Erector spinae plane block (ESPB) is a novel nerve block that has been used for analgesia for surgeries of the chest and abdominal wall. Using a bony structure, the transverse process, as the end point, the block needle is very unlikely to cause injury to vital structures as is possible with TEA or PVB (for examples, the spinal cord, lungs and blood vessels). It is also technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported. ESPB has also showed promise in managing CPSP after thoracic surgery in a small case series[4].

Given its safety, ease of performance and efficacy, the study aims to study the analgesic efficacy of ESPB in addition to systemic analgesia compared to systemic analgesia alone in patients undergoing VATS. The hypothesis is that ESPB and systemic analgesia will provide better analgesia when compared to systemic analgesia alone.

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Adult patients
2. Scheduled for an elective VATS
3. American Society of Anesthesiologists (ASA) physical status I to III

Exclusion Criteria:

1. Age < 18
2. BMI > 40
3. Patient refusal or inability to provide consent
4. Chronic pain conditions
5. Daily opioid use > 60 mg of oral morphine equivalents
6. Cognitive or psychiatric condition that makes it challenge to assess pain
7. Conversion to open thoracotomy
8. Allergy to any of the drugs used in this study
9. Contraindication to nerve blocks such as infection, severe coagulopathy or pre-existing neuropathy
10. Significant systemic cardiac, respiratory, hepatic or renal diseases
11. Postoperative admission to intensive care unit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham Block; Patient will receive a single shot of normal saline 20 mL injected at the erector spinae plane	Drug: Normal saline; Normal saline will be injected in the erector spinae plane; Other Names: Sham block
Active Comparator: Erector Spinae Block; Patient will receive a single shot of Ropivacaine Injection [Naropin] 0.5% 20 mL injected at the erector spinae plane	Drug: Ropivacaine Injection [Naropin]; Ropivacaine will be injected in the erector spinae plane; Other Names: Erector spinae block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in IV morphine equivalents	All source of opioid	First postoperative 24 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in IV morphine equivalents	All source of opioid	Second postoperative 24 hours
Area under curve of pain score	0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)	First postoperative 24 hour
Area under curve of pain score	0 - 10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)	Second postoperative 24 hour
Post-anesthetic recovery length of stay	In minutes	up to 12 hours
Hospital length of stay	in hours	Up to 1 week
Incidence of nausea	patient reported sensation of nausea related to opioid intake	Up to 1 week
Incidence of vomiting	nurse recorded incidence of vomiting related to opioid intake	Up to 1 week
Incidence of drowsiness	lightheadedness, drowsiness reported by patient related to opioid intake	Up to 1 week
Incidence of pruritus	new onset of pruritus related to opioid intake	Up to 1 week
Incidence of infection at block injection site	defined as redness, swelling, tenderness and/or prurulent discharge	Up to 1 week
Incidence of symptomatic hematoma at block injection site	collection of blood confirmed by ultrasound	Up to 1 week
Incidence of paresthesia in the area covered by block	paresthesia, decreased sensation thought to related to block	Up to 1 week
Incidence of hypoxia	hypoxia (SaO2 < 90%) despite > 5 L oxygen	during the first 24 hours
Incidence of mechanical ventilation	requiring re-intubation	during the first 24 hours
Incidence of tachypnea	Respiratory rate more than 30 for more than 2 hours	during the first 24 hours

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: July 25, 2018
• First Submitted That Met QC Criteria: August 8, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 112452

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No