Erector Spinae Plane Block For Analgesia Following Video-Assisted Thoracoscopic Surgery

NCT ID: NCT03860480

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-29

Study Completion Date

2021-12-16

Brief Summary

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Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Detailed Description

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A growing number of thoracic surgeries are performed with a minimally invasive approach called video-assisted thoracoscopic surgery (VATS). VATS has reduced the incision size, the postoperative pain and the morbidity associated with thoracic surgery. Optimal postoperative analgesia for VATS surgery remains an open issue because although it is a lot less painful than a thoracotomy, VATS is a painful procedure with the associated risk of developing chronic pain. Adequate relief leads to early mobilization, potentially improves respiratory functions, and decreases the global stress response secondary to the surgery.

Invasive analgesic techniques such as epidural or paravertebral block for VATS surgery are frequently being replaced for less invasive plane blocks to provide postoperative analgesia. At our center, anesthesiologists tend to perform epidurals only when there is a significant risk of transitioning to an open thoracotomy. Patient controlled analgesia (PCA), remains the usual analgesic technique for VATS surgery at our institution.

Erector spinae (ESP) block is a recently described plane block designed to block the dorsal and ventral rami of the thoracic spinal nerves. It is meant to block the ipsilateral trunk. The aim of the study is to demonstrate the efficacy of the ESP block as postoperative analgesia for VATS surgery.

Conditions

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Thoracic Surgery, Video-Assisted

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Sham Erector Spinae Plane Block Intervention group : Postoperative patient-controlled analgesia (PCA) pumps with Hydromorphone + Erector Spinae Plane Block
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ESP with Bupivacaine 0.5%

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.

Thirty milliliters of bupivacaine at a concentration of 0.5% with epinephrine 1:200 000 will be injected depending on the patient's allocation.

Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).

Group Type ACTIVE_COMPARATOR

ESP with Bupivacaine 0.5%

Intervention Type PROCEDURE

Regional anesthesia procedure with Bupivacaïne 0.5%

ESP with Saline 0.9%

The Erector Spinae Block (ESP) will be performed using the method described by Forero et al and Hamilton et al. in 2017 by an expert regional anesthesiologist.

Thirty milliliters of a placebo solution (normal saline) will be injected depending on the patient's allocation.

Patient controlled analgesia (PCA) settings for both groups will remain the same: hydromorphone with a bolus of 0,2 mg, lockout time of 5 minutes and no background infusion. The PCA will be started when the patient is transferred to the postanesthesia care unit (PACU).

Group Type SHAM_COMPARATOR

ESP with Saline 0.9%

Intervention Type PROCEDURE

Regional anesthesia procedure with Normal Saline

Interventions

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ESP with Bupivacaine 0.5%

Regional anesthesia procedure with Bupivacaïne 0.5%

Intervention Type PROCEDURE

ESP with Saline 0.9%

Regional anesthesia procedure with Normal Saline

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

• Patients \> 18 years old with to ASA status I-III, undergoing VATS for lobectomy or wedge.


* \< 18 years old
* BMI \> 35
* Chronic pain history with regular opioid and/or gabapentinoids use during the 2 weeks before surgery
* Regular marijuana use
* History of thoracic surgery on the operated side
* Epidural analgesia preferred due to an anticipated high risk of conversion to thoracotomy
* Unable to communicate with the investigators
* Receiving anticoagulation or experiencing any bleeding disorder
* Surgery for empyema and sympathectomy
* Known allergy to local anesthetics, fentanyl or hydromorphone
* Active infection at injection sites
* Preexisting neurological deficit or psychiatric illness
* Severe cardiovascular disease
* Liver failure
* Renal failure (estimated glomerular filtration rate \<15 mL/ min/1.73 m2)
* Pregnancy

Exclusion Criteria

* Perioperative conversion to thoracotomy
* Severe intra- or postoperative bleeding
* Patients requiring postoperative mechanical ventilation
* Technical inability to proceed with the blocks
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ciusss de L'Est de l'Île de Montréal

OTHER

Sponsor Role lead

Responsible Party

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Ariane Clairoux

Assistant Professor Anesthesiology and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ariane Clairoux, MD

Role: PRINCIPAL_INVESTIGATOR

Maisonneuve-Rosemont Hospital / CIUSSS de l'Est-de-l'Île-de-Montréal

Locations

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Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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Alzahrani T. Pain relief following thoracic surgical procedures: A literature review of the uncommon techniques. Saudi J Anaesth. 2017 Jul-Sep;11(3):327-331. doi: 10.4103/sja.SJA_39_17.

Reference Type BACKGROUND
PMID: 28757835 (View on PubMed)

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Reference Type BACKGROUND
PMID: 28188621 (View on PubMed)

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

Reference Type BACKGROUND
PMID: 28919152 (View on PubMed)

Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.

Reference Type BACKGROUND
PMID: 28203765 (View on PubMed)

Kaplowitz J, Papadakos PJ. Acute pain management for video-assisted thoracoscopic surgery: an update. J Cardiothorac Vasc Anesth. 2012 Apr;26(2):312-21. doi: 10.1053/j.jvca.2011.04.010. Epub 2011 Jun 25. No abstract available.

Reference Type BACKGROUND
PMID: 21705236 (View on PubMed)

Kartalov A, Jankulovski N, Kuzmanovska B, Zdravkovska M, Shosholcheva M, Spirovska T, Petrusheva AP, Tolevska M, Srceva M, Durnev V, Jota G, Selmani R, Sivevski A. Effect of Adding Dexamethasone as a Ropivacaine Adjuvant in Ultrasound-Guided Transversus Abdominis Plane Block for Inguinal Hernia Repair. Pril (Makedon Akad Nauk Umet Odd Med Nauki). 2015;36(3):35-41. doi: 10.1515/prilozi-2015-0076.

Reference Type BACKGROUND
PMID: 27442394 (View on PubMed)

Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

Reference Type BACKGROUND
PMID: 27939192 (View on PubMed)

Khoshbin E, Al-Jilaihawi AN, Scott NB, Prakash D, Kirk AJ. An audit of pain control pathways following video-assisted thoracoscopic surgery. Innovations (Phila). 2011 Jul;6(4):248-52. doi: 10.1097/IMI.0b013e31822b2cc1.

Reference Type BACKGROUND
PMID: 22437983 (View on PubMed)

Kim DH, Oh YJ, Lee JG, Ha D, Chang YJ, Kwak HJ. Efficacy of Ultrasound-Guided Serratus Plane Block on Postoperative Quality of Recovery and Analgesia After Video-Assisted Thoracic Surgery: A Randomized, Triple-Blind, Placebo-Controlled Study. Anesth Analg. 2018 Apr;126(4):1353-1361. doi: 10.1213/ANE.0000000000002779.

Reference Type BACKGROUND
PMID: 29324496 (View on PubMed)

Kosinski S, Fryzlewicz E, Wilkojc M, Cmiel A, Zielinski M. Comparison of continuous epidural block and continuous paravertebral block in postoperative analgaesia after video-assisted thoracoscopic surgery lobectomy: a randomised, non-inferiority trial. Anaesthesiol Intensive Ther. 2016;48(5):280-287. doi: 10.5603/AIT.2016.0059.

Reference Type BACKGROUND
PMID: 28000203 (View on PubMed)

Lonnqvist PA, MacKenzie J, Soni AK, Conacher ID. Paravertebral blockade. Failure rate and complications. Anaesthesia. 1995 Sep;50(9):813-5. doi: 10.1111/j.1365-2044.1995.tb06148.x.

Reference Type BACKGROUND
PMID: 7573876 (View on PubMed)

Okmen K, Metin Okmen B. Evaluation of the effect of serratus anterior plane block for pain treatment after video-assisted thoracoscopic surgery. Anaesth Crit Care Pain Med. 2018 Aug;37(4):349-353. doi: 10.1016/j.accpm.2017.09.005. Epub 2017 Oct 12.

Reference Type BACKGROUND
PMID: 29033355 (View on PubMed)

Scimia P, Basso Ricci E, Droghetti A, Fusco P. The Ultrasound-Guided Continuous Erector Spinae Plane Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Lobectomy. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):537. doi: 10.1097/AAP.0000000000000616. No abstract available.

Reference Type BACKGROUND
PMID: 28632673 (View on PubMed)

Steinthorsdottir KJ, Wildgaard L, Hansen HJ, Petersen RH, Wildgaard K. Regional analgesia for video-assisted thoracic surgery: a systematic review. Eur J Cardiothorac Surg. 2014 Jun;45(6):959-66. doi: 10.1093/ejcts/ezt525. Epub 2013 Nov 27.

Reference Type BACKGROUND
PMID: 24288340 (View on PubMed)

Taylor R, Massey S, Stuart-Smith K. Postoperative analgesia in video-assisted thoracoscopy: the role of intercostal blockade. J Cardiothorac Vasc Anesth. 2004 Jun;18(3):317-21. doi: 10.1053/j.jvca.2004.03.012.

Reference Type BACKGROUND
PMID: 15232812 (View on PubMed)

Other Identifiers

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MP-12-2019-1640

Identifier Type: -

Identifier Source: org_study_id

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