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Ultrasound-guided Serratus Block and the Emergence of Post-thoracotomy Pain Syndrome

Primary Purpose

Thoracic Neuritis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Serratus anterior plane catheter block
Patient controlled analgesia
Sponsored by
National Cancer Institute, Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Thoracic Neuritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age > 18y
  • American Society of Anesthethiologists (ASA) physical status II or III .
  • Patient will undergo thoracotomy for lung resection procedures (metastatectomy, segmentectomy lobectomy, pneumonectomy or pleuropneumonectomy).

Exclusion Criteria:

  • Patients with history of drugs (opioids, L.A., NSAIDs) allergy.
  • Morbid obese patients (BMI >40) .
  • Major cardiorespiratory, hepatic, renal, endocrinal or hematological disorders.
  • Patients on chronic analgesic therapy (daily morphine ≥ 30 mg or equivalent dose of other opioids).
  • History of drug abuse and neuropsychiatric diseases .
  • History of thoracic cancer surgery within the last five years or patients having chest recurrence within 6 months.
  • Patients having severe intra or post-operative bleeding or demanding postoperative ventilation will be also excluded from the study.

Sites / Locations

  • Department of Anesthesia and Pain medicine.National Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Pump based patient controlled analgesia

serratus anterior plane catheter block

Arm Description

Analgesia is maintained using disposable silicon ballon pump "Accufuser" containing morphine 0.2 mg/ml, 8mg ondansetron plus and 180 mg ketorolac. The infusion rate is 5 ml / h and lockout interval of 15min. the hourly delivered morphine dose is 1-1.8 mg & the pump is sufficient for about 60 hours according to patient response.

Linear ultrasound transducer (superficial) 6-12 MHz is utilized to count the ribs up to 4th or 5 th rib in the mid-axillary line. Musculature of thoracic wall is identified sonographically,an echogenic needle "14-16 G, 100 mm" is inserted in plane with the U/S probe towards the plane deep to the serratus anterior muscle. Under real - time U/S, single shot of 20ml contrast medium "iohexol = omnipaque" 150 mg I2 / ml is injected to check the plane and level (T3-T8/9) of SAPB.A reinforced radiopaque catheter is threaded through the needle and its final position underneath the plane of serratus anterior muscle is confirmed fluoroscopically. 20ml 0.25% levobupivacaine (Chirocaine).Analgesia is maintained using 0.125% levobupivacaine infusion at a rate of 7-12 ml/h according to patient response.

Outcomes

Primary Outcome Measures

Assessment for the possible emergence of post - thoracotomy pain syndrome .
The neuropathic PTPS cases are screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS having neuropathic component is grade 3 (probable) or 4 (definite) i.e GSNP ≥3 .

Secondary Outcome Measures

Assessment of patient daily activity and functional capacity.
Activity of daily living score (ADL score).It comprises 6 basic daily activities (feeding, toilet, bathing, dressing, grooming and walking) with each item is scored either 1= need no help, 2=need some help, 3=need complete help
Assessment of patient's quality of life.
Flanagan quality of life scale.A 16 items (domains) questionnaire with each item weights 1 to 7 points.the total score ranges from 16 to 112 .Higher values indicate better quality of life .It will be explained to the patients by the pain physician and the total score will be calculated and recorded

Full Information

First Posted
April 23, 2018
Last Updated
July 15, 2018
Sponsor
National Cancer Institute, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03533426
Brief Title
Ultrasound-guided Serratus Block and the Emergence of Post-thoracotomy Pain Syndrome
Official Title
The Impact of Ultrasound-guided Serratus Anterior Plane Catheter Block (SAPB) Following Thoracotomy for Chest Malignancies on the Emergence of Post-thoracotomy Pain Syndrome (PTPS): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 27, 2018 (Actual)
Primary Completion Date
July 15, 2018 (Actual)
Study Completion Date
July 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Institute, Egypt

4. Oversight

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

5. Study Description

Brief Summary
The aim of this prospective, single blinded, comparative pilot study is to evaluate U/S guided serratus anterior plane catheter block (SAPB) versus patient-controlled analgesia (PCA) on the emergence of post - thoracotomy pain syndrome (PTPS). The investigator's assumed hypothesis is that; SAPB is an effective thoracic analgesic technique that may reduce the development of PTPS.
Detailed Description
Lung cancer has the highest incidence of all malignancies worldwide & represents about 13% of all cancer victims. Lung cancer still represents the first cause of cancer deaths and lung resection surgeries could be the main therapeutic procedure. Hence, the number of thoracotomies is progressively increasing with more & more post- thoracotomy pain . Together with amputation, thoracotomy is considered the main etiology of severe & long-term acute and chronic post-surgical pain syndromes (CPSP). The prevalence of post - thoracotomy pain syndrome (PTPS) is variable (30-50%). The international association for the study of pain (IASP) has defined PTPS as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure".Besides, PTPS is mostly described with neuropathic manifestations along the thoracotomy scar, mammary & submammary ipsilateral scapular & interscapular areas. Pain is often aching, burning with tingling, numbness, pruritis plus sensory loss and/or hypoesthesia.Preemptive post-thoracotomy analgesia is mostly multimodal & integrates both systemic & regional techniques. Systemic drugs (either given parenterally or through patient controlled - analgesia "PCA") include, NSAIDs, Cox - II inhibitors, paracetamol, opioids, ketamine (as N-methyl-D- aspartate blocker), gabapentins & pregabalin, selective serotonin re-uptake inhibitors and/or duloxetine .Regional analgesic techniques include thoracic epidural analgesia (TEA) which, is considered by many as the gold standard analgesic mode for post-thoracotomy pain .Other regional analgesic techniques are paravertebral analgesia (PVB), intercostal nerve blocks and intrapleural analgesia.Recently SAPB has been practiced more widely as an U/S - guided, simple technique of effective post-thoracotomy analgesia which is comparable with standard techniques such as TEA and PVB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neuritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
the data collector will be blinded to the study groups
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pump based patient controlled analgesia
Arm Type
Active Comparator
Arm Description
Analgesia is maintained using disposable silicon ballon pump "Accufuser" containing morphine 0.2 mg/ml, 8mg ondansetron plus and 180 mg ketorolac. The infusion rate is 5 ml / h and lockout interval of 15min. the hourly delivered morphine dose is 1-1.8 mg & the pump is sufficient for about 60 hours according to patient response.
Arm Title
serratus anterior plane catheter block
Arm Type
Active Comparator
Arm Description
Linear ultrasound transducer (superficial) 6-12 MHz is utilized to count the ribs up to 4th or 5 th rib in the mid-axillary line. Musculature of thoracic wall is identified sonographically,an echogenic needle "14-16 G, 100 mm" is inserted in plane with the U/S probe towards the plane deep to the serratus anterior muscle. Under real - time U/S, single shot of 20ml contrast medium "iohexol = omnipaque" 150 mg I2 / ml is injected to check the plane and level (T3-T8/9) of SAPB.A reinforced radiopaque catheter is threaded through the needle and its final position underneath the plane of serratus anterior muscle is confirmed fluoroscopically. 20ml 0.25% levobupivacaine (Chirocaine).Analgesia is maintained using 0.125% levobupivacaine infusion at a rate of 7-12 ml/h according to patient response.
Intervention Type
Procedure
Intervention Name(s)
Serratus anterior plane catheter block
Intervention Description
Ultrasonographic guided placement of a catheter under the serratus anterior muscle in cases of open thoracotomies for chest malignancies in an attempt to reduce the emergence of postthoracotomy pain syndrome.
Intervention Type
Procedure
Intervention Name(s)
Patient controlled analgesia
Intervention Description
The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome
Primary Outcome Measure Information:
Title
Assessment for the possible emergence of post - thoracotomy pain syndrome .
Description
The neuropathic PTPS cases are screened using the grading system for neuropathic pain (GSNP). Positive cases of PTPS having neuropathic component is grade 3 (probable) or 4 (definite) i.e GSNP ≥3 .
Time Frame
changes in 4 and 12 weeks .
Secondary Outcome Measure Information:
Title
Assessment of patient daily activity and functional capacity.
Description
Activity of daily living score (ADL score).It comprises 6 basic daily activities (feeding, toilet, bathing, dressing, grooming and walking) with each item is scored either 1= need no help, 2=need some help, 3=need complete help
Time Frame
changes in 4 and 12 weeks .
Title
Assessment of patient's quality of life.
Description
Flanagan quality of life scale.A 16 items (domains) questionnaire with each item weights 1 to 7 points.the total score ranges from 16 to 112 .Higher values indicate better quality of life .It will be explained to the patients by the pain physician and the total score will be calculated and recorded
Time Frame
changes in 4 and 12 weeks .

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age > 18y American Society of Anesthethiologists (ASA) physical status II or III . Patient will undergo thoracotomy for lung resection procedures (metastatectomy, segmentectomy lobectomy, pneumonectomy or pleuropneumonectomy). Exclusion Criteria: Patients with history of drugs (opioids, L.A., NSAIDs) allergy. Morbid obese patients (BMI >40) . Major cardiorespiratory, hepatic, renal, endocrinal or hematological disorders. Patients on chronic analgesic therapy (daily morphine ≥ 30 mg or equivalent dose of other opioids). History of drug abuse and neuropsychiatric diseases . History of thoracic cancer surgery within the last five years or patients having chest recurrence within 6 months. Patients having severe intra or post-operative bleeding or demanding postoperative ventilation will be also excluded from the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ehab H Shaker, MD
Organizational Affiliation
National Cancer Institute- Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anesthesia and Pain medicine.National Cancer Institute
City
Cairo
ZIP/Postal Code
11796
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the final results and conclusion can be shared after finishing and submitting the trial .

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Ultrasound-guided Serratus Block and the Emergence of Post-thoracotomy Pain Syndrome

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