- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07437027
Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia (ESPvsTPVB)
Analgesic Efficiency of Erector Spinae Plane Block Versus Thoracic Paravertebral Block in Patients Undergoing Lateral Thoracotomy Using Opoid Sparing Anesthesia . A Comparative Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
There is growing evidence showing that opoid-free anesthesia (OFA), including loco-regional anesthesia and non-opioid drugs, is feasible in several surgical settings. The surgeries for pathologies involving the lungs and mediastinum involves different types of thoracic surgical incision such as anterolateral or posterolateral.
Post thoracotomy pain affects 30%-50% of the patients undergoing thoracotomy.Poorly managed pain following thoracotomy can lead to increase the risk of complications such as lung collapse and chest infections due to altered mechanical functions of the lungs and ventilation-perfusion mismatch. Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves,the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.
So, Analgesia is a major determinant of balanced anesthesia and it is usually achieved by administering opioid agents, which are well tolerated and maintain hemodynamic stability in the perioperative period. However, perioperative opioid administration is not risk-free. Opioids are associated with life-threatening side effects such as respiratory depression, postoperative nausea and vomiting, opioid-induced hyperalgesia, constipation, urinary retention, immunomodulation and neurotoxicity. In addition, opioid prescription after surgery seems to trigger the development of opioid addiction, thus contributing to the widespread opioid misuse observed worldwide. Several studies found a correlation between postoperative opioid administration, the development of chronic pain and opioid addiction.
Therefore,opioid administration should be reduced or avoided as much as possible.
Thoracic epidural analgesia (TEA) is considered as the gold standard for thoracotomy pain(4)However, according to a recent systematic review, The thoracic paravertebral block (TPVB) has been shown to be as effective as TEA with reduction of the risks of minor complications compared to TEA.
Emerging research has shown that the novel erector spinaeplane block(ESPB) can be employed as a simple and safe alternative analgesic technique for acute postsurgical, post-traumatic, and chronic neuropathic thoracic pain in adults.
The goal of this study is to assess the Analgesic efficiency of erector spinae plane block versus thoracic paravertebral block in patients undergoing lateral thoracotomy using opoid sparing anesthesia.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eman Mamdouh Mahmoud Hussien (emanmmh), Assistant lecturer
- Phone Number: 201002087146
- Email: Eman.mamdouh31@gmail.com
Study Locations
-
-
Kasr Alaini
-
Cairo, Kasr Alaini, Egypt
- Kasr Al Aini Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients age between 18 and 70 .
- Patients with ASAII and IIIstatus.
- Patients undergoing open surgical Thoracotomy as in lobectomy, pneumonectomy, segmentectomy and decortication.
Gender both males and females.
2.Exclusioncriteria
- Refusal of the patient.
- Allergy to local anesthetic
- Infection of the skin at the site of local infiltration
- Cardiovascular problems (arrhythmia, heart block, SVT,AF, multiple extra systole).
- Any contraindication to regional anesthesia as coagulopathy
- Patients with chronic pain or on opoid medication preoperative
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A : thoracic para vertebral block
Patients in this arm will receive ultrasound guided thoracic paravertebral block at the T5 level using 20 ml of 0.5% bupivacaine protocol for lateral thoracotomy
|
Ultrasound guided thoracic paravertebral block performed at the T5 level using 20 ml of 0.5% bupivacaine for postoperative analgesia in patients undergoing lateral thoracotomy
|
|
Experimental: Group B : erector spinae plane block
Patients in this arm will receive ultrasound guided erector spinae plane block at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy
|
ultrasound guided erector spinae plane block will be performed at the T5 level using 20 ml of 0.5% bupivacaine as part of an opoid sparing anesthesia protocol for lateral thoracotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total morphine consumption for the first 24 hours postoperative
Time Frame: Within the first 24 hours postoperative
|
Within the first 24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain
Time Frame: At 0,2,6,12,24 hours post operative
|
Postoperative pain will be assessed using vas score at 0,2,6,12,24 hours post operative
|
At 0,2,6,12,24 hours post operative
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20.
- Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available.
- Marshall K, McLaughlin K. Pain Management in Thoracic Surgery. Thorac Surg Clin. 2020 Aug;30(3):339-346. doi: 10.1016/j.thorsurg.2020.03.001. Epub 2020 Apr 29.
- Mamoun N, Wright MC, Bottiger B, Plichta R, Klinger R, Manning M, Raghunathan K, Gulur P. Pain Trajectories After Valve Surgeries Performed via Midline Sternotomy Versus Mini-Thoracotomy. J Cardiothorac Vasc Anesth. 2022 Sep;36(9):3596-3602. doi: 10.1053/j.jvca.2022.05.007. Epub 2022 May 10.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Post thoracotomy pain
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post Thoracotomy Pain
-
University of Maryland, BaltimoreAtriCure, Inc.RecruitingChronic Post-thoracotomy Pain | Post-thoracotomy Pain Syndrome | Acute Post-thoracotomy PainUnited States
-
Assiut UniversityCompleted
-
Bursa City HospitalCompletedPost-thoracotomy PainTurkey (Türkiye)
-
Zagazig UniversityCompleted
-
University of Campania "Luigi Vanvitelli"CompletedPost Thoracotomy PainItaly
-
National Taiwan University HospitalRecruitingPost-thoracotomy Pain SyndromeTaiwan
-
Cairo UniversityRecruitingPost-thoracotomy Pain SyndromeEgypt
-
National Cancer Institute, EgyptCompletedPost-thoracotomy Pain SyndromeEgypt
-
The University of Texas Medical Branch, GalvestonMallinckrodtWithdrawnPost-thoracotomy Pain Syndrome
-
Weill Medical College of Cornell UniversityWithdrawnLaser Therapy | Post Thoracotomy PainUnited States
Clinical Trials on Group A :Thoracic paravertebral block
-
Larissa University HospitalUnknownBreast Surgery | Autonomic Nervous System | Thoracic Paravertebral Block | HRVGreece
-
Tongji HospitalRecruitingPneumothorax | Acute Respiratory Distress Syndrome (ARDS) | Atelectasis | Video-assisted Thoracoscopic Surgery (VATS) | Bronchospasm | Lung Cancer (Diagnosis) | Pulmonary Infections | Bronchopleural Fistula | Pleural Effusion Due to Another Disorder (Disorder) | Pulmonary Embolism (Diagnosis) | Respiratory...China
-
Bursa City HospitalRecruitingPost-thoracotomy PainTurkey (Türkiye)
-
Tanta UniversityCompletedAnalgesia | Erector Spinae Plane Block | Paravertebral Block | Video-Assisted Thoracic Surgery | Transversus Thoracic Muscle Plane BlockEgypt
-
National Cancer Institute, EgyptRecruitingLung Cancer | Thoracotomy | Thoracic Paravertebral Block | Costotransverse Foramen BlockEgypt
-
Loyola UniversityUnknown
-
Tanta UniversityCompleted
-
Zagazig UniversityRecruitingDiscitis of Thoracic RegionEgypt
-
Ciusss de L'Est de l'Île de MontréalRecruitingBreast Cancer | Breast Neoplasms | Breast Neoplasm Female | Cancer, BreastCanada