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Erector Spinae Plane Block for Post-thoracotomy Pain

Primary Purpose

Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
erector spinae plane block with ropivacaine
Intercostal nerve block with ropivacaine
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring erector spinae plane block, thoracotomy, ultrasound guided nerve block, analgesia

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • Sant Andrea Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group E

group I

Arm Description

patients receiving the ESP block

patients receiving the intercostal nerve block

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

opioid consumption
the amount of opioid used during the surgical procedure (remifentanil, mcg)
function and strength of the respiratory muscle
respiratory pressure meter measuring MIP (maximal inspiratory pressure) and MEP (maximal expiratory pressure)
patient satisfaction about the analgesia technique
Likert satisfaction scale,Satisfaction rate ranged from 5 meaning highly satisfied to 1 meaning highly unsatisfied.

Full Information

First Posted
July 3, 2019
Last Updated
March 23, 2020
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT04013815
Brief Title
Erector Spinae Plane Block for Post-thoracotomy Pain
Official Title
Erector Spinae Plane Block Versus Intrapleural Intercostal Plane Block for Post-thoracotomy Pain: a Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
November 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Post-thoracotomy pain is one of the most severe forms of post-operative pain that can be attributed to muscle incision, rib retraction or resection, and damage to the intercostal nerves. Inadequate control of this post-operative pain can contribute to a deterioration of the respiratory function, with limitation of the ventilation, appearance of atelectasis, ineffective cough, and increased risk of infectious complications. Moreover, recent evidence shows that persistent pain after surgery, in addition to being responsible for chronic post-surgical pain syndrome, is associated with a delay in post-operative recovery and a return to normal daily life activities. The most common techniques for the management of post-thoracotomy pain are in addition to systemic intravenous analgesia, thoracic epidural, paravertebral nerve block and intercostal nerve block. Although the thoracic epidural has been considered for years the gold standard for the control of post-operative pain following thoracotomy, it is not risk-free, requires an expert operator, and can be contraindicated in some categories of patients. The intercostal nerve block, performed through the injection of the local anesthetic in multiple intercostal spaces before performing thoracotomy, may be one of the alternatives to a thoracic epidural in terms of safety and efficacy and is technically easy and quick to perform. This block is found to be particularly effective in reducing post-operative pain when associated with a mini-thoracotomy, helping to improve the outcome of patients undergoing major lung resection. A technique of more recent description (2016) is the erector spinae plane block (ESP) . This interfascial block is performed in the posterior thoracic region homolaterally at the site of the intervention at the level of the T5 transverse process (fifth thoracic vertebra), the ultrasound marker of the block. The ESP block is easy and safe to perform thanks to the ultrasound-guided method and the absence of vascular-nerve structures at risk of damage in the vicinity of the injection site and allows analgesia of the posterior and anterolateral thoracic wall and of the axillary region. In fact, cadaveric studies have shown an anesthetic distribution both in the cranial caudal sense (T2-T8) along the fascia between erector spinae and large rhomboid, and in the anteroposterior direction, with the blockage of the spinal thoracic nerve roots. ESP block was described in the treatment of chronic chest pain in the first place, but was subsequently used as rescue therapy in acute post-thoracotomy pain; it has also been tested in upper abdominal surgery, performed bilaterally. Use in four cases of acute post video thoracoscopy pain management has also been described. Recently, some randomized controlled trials have been carried out that showed: greater analgesic efficacy of ESP compared to intravenous multimodal analgesia standard for the treatment of post-operative pain, with less recourse to rescue doses of morphine following laparoscopic cholecystectomy, mastectomy and cardiac surgery. To date, there are no studies that compare its efficacy with other pain relief methods in acute post-thoracotomy pain. The objective of our study is to compare the analgesic efficacy of these two techniques in the control of acute post-thoracotomy chest pain, blockade of erector spinae vs intrapleural intercostal blockade.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
erector spinae plane block, thoracotomy, ultrasound guided nerve block, analgesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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)
Masking
ParticipantOutcomes Assessor
Masking Description
patients and investigator checking the pain are not aware of which block has been performed
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group E
Arm Type
Experimental
Arm Description
patients receiving the ESP block
Arm Title
group I
Arm Type
Active Comparator
Arm Description
patients receiving the intercostal nerve block
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block with ropivacaine
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Intercostal nerve block with ropivacaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
postoperative pain
Description
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
Time Frame
12 hours from surgery
Secondary Outcome Measure Information:
Title
opioid consumption
Description
the amount of opioid used during the surgical procedure (remifentanil, mcg)
Time Frame
through surgery completed
Title
function and strength of the respiratory muscle
Description
respiratory pressure meter measuring MIP (maximal inspiratory pressure) and MEP (maximal expiratory pressure)
Time Frame
12 hours from the surgery
Title
patient satisfaction about the analgesia technique
Description
Likert satisfaction scale,Satisfaction rate ranged from 5 meaning highly satisfied to 1 meaning highly unsatisfied.
Time Frame
12 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients undergoing thoracotomy lung resection surgery between 45 and 80 years Exclusion Criteria: 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
Facility Information:
Facility Name
Sant Andrea Hospital
City
Roma
ZIP/Postal Code
00189
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
6051231
Citation
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Results Reference
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2203902
Citation
Sabanathan S, Eng J, Mearns AJ. Alterations in respiratory mechanics following thoracotomy. J R Coll Surg Edinb. 1990 Jun;35(3):144-50.
Results Reference
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PubMed Identifier
2200485
Citation
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15763409
Citation
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Results Reference
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PubMed Identifier
3178353
Citation
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.
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PubMed Identifier
16481188
Citation
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Results Reference
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PubMed Identifier
28919152
Citation
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PubMed Identifier
29336785
Citation
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.
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PubMed Identifier
29913392
Citation
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.
Results Reference
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PubMed Identifier
29980005
Citation
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.
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PubMed Identifier
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Citation
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. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.
Results Reference
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Erector Spinae Plane Block for Post-thoracotomy Pain

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