Erector Spinae Plane Block for Post-thoracotomy Pain

NCT04013815 | Completed

• 1 other identifier: ESP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Post-thoracotomy pain is one of the most severe forms of post-operative pain. Among the most common techniques for the management of post-thoracotomy pain, there are the intercostal nerve block, and a recently described block, the erector spinae plane block (ESP).To date, there are no studies that compare the efficacy of ESP block with other pain relief methods in acute post-thoracotomy pain. The objective of this randomized study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, block of erector spinae vs intrapleural intercostal block.

Conditions

Pain, Postoperative

Keywords

erector spinae plane block; thoracotomy; ultrasound guided nerve block; analgesia

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  efficacy measured through the evaluation of the NRS score (Numerical Rating Scale) , that ranges from '0' representing one pain extreme (e.g. " no pain") to '10' representing the other pain extreme

  12 hours from surgery

Secondary Outcomes (3)

• opioid consumption

  through surgery completed

• function and strength of the respiratory muscle

  12 hours from the surgery

• patient satisfaction about the analgesia technique

  12 hours after surgery

Study Arms (2)

group E

EXPERIMENTAL

patients receiving the ESP block

Procedure: erector spinae plane block with ropivacaine

group I

ACTIVE COMPARATOR

patients receiving the intercostal nerve block

Procedure: Intercostal nerve block with ropivacaine

Interventions

erector spinae plane block with ropivacaine PROCEDURE

The block is performed immediately before surgery. by an ultrasound guide, with the probe positioned longitudinally, the spinous process of T5 is identified. A peripheral block needle is inserted in the cephalo-caudal direction (caliber 21G and length 10 cm) and 3 ml of physiological solution are injected to confirm the injection site: fascial plane between the erector spinae muscle and the large rhomboid, near the tip of the transverse process of T5. Once the correct position of the needle tip has been confirmed, ropivacaine 0.75% 20 ml is injected.

group E

Intercostal nerve block with ropivacaine PROCEDURE

The intercostal nerve block will be performed by the surgeon at the time of thoracotomy from the 4th to the 8th intercostal space, by injecting 20 ml of 0.75% ropivacaine (4 ml for each space). The injection is performed at about 2-3 cm from the spine.

group I

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing thoracotomy lung resection surgery between 45 and 80 years

You may not qualify if:

• Patients allergic to the drugs used in the study
• Patients with diabetic neuropathy
• Patients with severe hepatic or renal insufficiency
• emergent surgery
• Age \<45 years or\> 80 years

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Sant Andrea Hospital

Roma, 00189, Italy

Location

Related Publications (11)

• Loan WB, Morrison JD. The incidence and severity of postoperative pain. Br J Anaesth. 1967 Sep;39(9):695-8. doi: 10.1093/bja/39.9.695. No abstract available.

  PMID: 6051231 BACKGROUND

• Sabanathan S, Eng J, Mearns AJ. Alterations in respiratory mechanics following thoracotomy. J R Coll Surg Edinb. 1990 Jun;35(3):144-50.

  PMID: 2203902 BACKGROUND

• Nunn JF. Effects of anaesthesia on respiration. Br J Anaesth. 1990 Jul;65(1):54-62. doi: 10.1093/bja/65.1.54. No abstract available.

  PMID: 2200485 BACKGROUND

• Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. doi: 10.1016/j.atc.2004.11.013.

  PMID: 15763409 BACKGROUND

• Sabanathan S, Smith PJ, Pradhan GN, Hashimi H, Eng JB, Mearns AJ. Continuous intercostal nerve block for pain relief after thoracotomy. Ann Thorac Surg. 1988 Oct;46(4):425-6. doi: 10.1016/s0003-4975(10)64657-7.

  PMID: 3178353 BACKGROUND

• D'Andrilli A, Ibrahim M, Ciccone AM, Venuta F, De Giacomo T, Massullo D, Pinto G, Rendina EA. Intrapleural intercostal nerve block associated with mini-thoracotomy improves pain control after major lung resection. Eur J Cardiothorac Surg. 2006 May;29(5):790-4. doi: 10.1016/j.ejcts.2006.01.002. Epub 2006 Feb 14.

  PMID: 16481188 BACKGROUND

• 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.

  PMID: 28919152 BACKGROUND

• Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.

  PMID: 29336785 BACKGROUND

• Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

  PMID: 29913392 BACKGROUND

• Gurkan Y, Aksu C, Kus A, Yorukoglu UH, Kilic CT. Ultrasound guided erector spinae plane block reduces postoperative opioid consumption following breast surgery: A randomized controlled study. J Clin Anesth. 2018 Nov;50:65-68. doi: 10.1016/j.jclinane.2018.06.033. Epub 2018 Jul 2.

  PMID: 29980005 BACKGROUND

• Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4.

  PMID: 30055991 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: patients and investigator checking the pain are not aware of which block has been performed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: 60 patients will be enrolled to undergo thoracotomy lung resection surgery. The population will be divided into two groups based on the type of block made: Group E: ESP block (n = 30) Group I: Intercostal block (n = 30)

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 10, 2019
• Study Start: August 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: November 30, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Locations

IT (1)