Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
Primary Purpose
Post-thoracotomy Pain Syndrome, Erector Spinae Plane Block, Serratus Anterior Plane Block
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thoracic epidural infusion
Erector Spinae Plane Block
Serratus Anterior Plane Block
Sponsored by
About this trial
This is an interventional treatment trial for Post-thoracotomy Pain Syndrome
Eligibility Criteria
Inclusion Criteria:
- Age (18-65) Years
- Physical status American Society of Anesthesiologists Classification II, III
- Patients undergoing lobectomy through lateral thoracotomy
- Body mass index (BMI): (20-40) kg/m2
Exclusion Criteria:
- Patient refusal.
- Age <18 years or >65 years
- Body mass index (BMI) <20 kg/m2 and >40 kg/m2
- Known sensitivity or contraindication to drugs used in the study
- Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
- Pregnancy.
- Physical status American Society of Anesthesiologists Classification IV
- patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
- patients with a history of drug abuse
- patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
- patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
- All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
- Thoracic spine disorders or deformity.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Thoracic epidural infusion group
Erector Spinae Plane Block group
Serratus Anterior Plane Block group
Arm Description
Patients will receive thoracic epidural preoperative
Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter
Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.
Outcomes
Primary Outcome Measures
Incidence of patients developing post-thoracotomy pain syndrome
The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
Secondary Outcome Measures
Morphine consumption
The total amount of morphine consumed postoperatively for 48 hours.
Fentanyl consumption
Total amount of fentanyl consumed intraoperative
Post-thoracotomy pain syndrome severity
Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
Patient's Quality of life
Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
Postoperative Patient's activity level
Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
Heart rate
Heart rate will be recorded
Mean arterial blood pressure
Mean arterial blood pressure will be recorded
Nausea and vomiting
Postoperative nausea and vomiting (PONV) will be recorded
Post-operative pain
Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
Time taken till 1st rescue analgesic request
The time till administration of first rescue analgesia will be recorded
Postoperative pulmonary complications
Postoperative pulmonary complications will be recorded
Full Information
NCT ID
NCT05409144
First Posted
June 3, 2022
Last Updated
June 3, 2022
Sponsor
National Cancer Institute, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT05409144
Brief Title
Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
Official Title
Impact of Thoracic Epidural Infusion Versus Continuous Serratus Anterior Plane Block Versus Continuous Erector Spinae Plane Block on Incidence of Post Thoracotomy Pain Syndrome: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 20, 2022 (Anticipated)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the impact of Ultrasound-guided Erector Spinae plane block compared to Ultrasound-guided serratus anterior plane block on the emergence of post-thoracotomy pain syndrome in patients undergoing lobectomy for lung cancer.
Detailed Description
Lung cancer has the highest incidence of all malignancies worldwide and accounts for approximately 13% of all cancer cases. Lung cancer is still the most common cause of cancer-related deaths, and lung resection surgeries could be the main therapeutic option. Hence, the number of thoracotomy procedures is progressively increasing as is the incidence of post-thoracotomy pain. In addition to amputation and mastectomy, thoracotomy is considered the main etiology of severe and long-term acute and chronic post-surgical pain syndromes (CPSPs). The prevalence of post-thoracotomy pain syndrome (PTPS) is widely variable (30%-50%) and may range from 11% to 80%, according to other studies.
The International Association for the Study of Pain (IASP) has defined post-thoracotomy pain syndrome as "pain that recurs or persists along the thoracotomy scar at least 2 months after the procedure". In addition, post-thoracotomy pain syndrome is mostly described with neuropathic manifestations along the thoracotomy scar and in the mammary, inframammary, ipsilateral scapular and interscapular areas.
The ultrasound-guided erector spinae plane (ESP) block is a novel technique for thoracic analgesia that promises to be a relatively simple and safe alternative to more complex and invasive techniques of neural blockade.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-thoracotomy Pain Syndrome, Erector Spinae Plane Block, Serratus Anterior Plane Block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
111 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracic epidural infusion group
Arm Type
Experimental
Arm Description
Patients will receive thoracic epidural preoperative
Arm Title
Erector Spinae Plane Block group
Arm Type
Experimental
Arm Description
Patients will receive Ultrasound-guided Erector Spinae Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25% and insertion of a catheter
Arm Title
Serratus Anterior Plane Block group
Arm Type
Experimental
Arm Description
Patients will receive Ultrasound-guided Serratus Anterior Plane Block preoperative with an injection of 30 ml levobupivacaine 0.25%.
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural infusion
Intervention Description
Upon locating the desired site spot, lidocaine 1% must be injected into the skin and underlying tissues to decrease the discomfort with the advancement of the epidural needle. Once achieving local anesthesia, the epidural needle advanced with its stylet in place and with its bevel point cephalad; this will ultimately contribute to the proper location of the epidural catheter. The epidural needle must be advanced through the skin, subcutaneous tissue, supraspinous, and interspinous ligaments. Once there, the stylet must be removed, and the Loss of Resistance syringe (filled up with saline, air, or both) must be attached to the needle. The needle must be advanced while applying pressure to the plunger. Once the ligamentum flavum is pierced, a loss in resistance will be noted; this is the epidural space, and 5 to 10 cc of saline is injected to expand the epidural space; this may decrease the risk of vascular injury.
Intervention Type
Device
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
The block-level will be at T5. The ultrasound probe will be placed on the back in a transverse orientation to identify the tip of the T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. The tip of the transverse process will be centered on the ultrasound screen and the probe will then be rotated into a longitudinal orientation to produce a parasagittal view, in which the following layers will be visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle and T5 transverse process. 3ml lidocaine 1% will be used on skin and subcutaneous fat, Echogenic block needle will be inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process.
Intervention Type
Device
Intervention Name(s)
Serratus Anterior Plane Block
Intervention Description
The block is performed with full aseptic precautions. Arm abduction is preferred. The ultrasound probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, then, 3ml lidocaine 1% will be used for skin and subcutaneous fat, using ultrasound guidance, a 38-mm 22-gauge regional block needle is going to be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid intravascular injection 30ml of levobupivacaine 0.25% will be injected anteriorly to the rib and deep into the serratus anterior muscle.
Primary Outcome Measure Information:
Title
Incidence of patients developing post-thoracotomy pain syndrome
Description
The incidence of patients developing post-thoracotomy pain syndrome according to grading system for neuropathic pain (GSNP
Time Frame
12 weeks postoperatively
Secondary Outcome Measure Information:
Title
Morphine consumption
Description
The total amount of morphine consumed postoperatively for 48 hours.
Time Frame
48 hours Postoperatively
Title
Fentanyl consumption
Description
Total amount of fentanyl consumed intraoperative
Time Frame
Intraoperatively
Title
Post-thoracotomy pain syndrome severity
Description
Severity of Post-thoracotomy pain syndrome according to Grading system for neuropathic pain (GSNP)
Time Frame
12 weeks postoperatively
Title
Patient's Quality of life
Description
Patient's Quality of life according to the Flanagan Quality of Life Scale (QOLS)
Time Frame
12 weeks postoperatively
Title
Postoperative Patient's activity level
Description
Postoperative Patient's activity level according to Barthel Activities of Daily Living scale (ADL)
Time Frame
12 weeks postoperatively
Title
Heart rate
Description
Heart rate will be recorded
Time Frame
Intraoperatively
Title
Mean arterial blood pressure
Description
Mean arterial blood pressure will be recorded
Time Frame
Intraoperatively
Title
Nausea and vomiting
Description
Postoperative nausea and vomiting (PONV) will be recorded
Time Frame
24 hours postopertivley
Title
Post-operative pain
Description
Post-operative pain will be assessed by the Numeric Rating Scale (NRS)
Time Frame
24 hours postopratively
Title
Time taken till 1st rescue analgesic request
Description
The time till administration of first rescue analgesia will be recorded
Time Frame
24 hours postopratively
Title
Postoperative pulmonary complications
Description
Postoperative pulmonary complications will be recorded
Time Frame
24 hours postopratively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age (18-65) Years
Physical status American Society of Anesthesiologists Classification II, III
Patients undergoing lobectomy through lateral thoracotomy
Body mass index (BMI): (20-40) kg/m2
Exclusion Criteria:
Patient refusal.
Age <18 years or >65 years
Body mass index (BMI) <20 kg/m2 and >40 kg/m2
Known sensitivity or contraindication to drugs used in the study
Contraindication to regional anesthesia e.g. local infection at site of introduction, pre-existing peripheral neuropathies and coagulopathy.
Pregnancy.
Physical status American Society of Anesthesiologists Classification IV
patients on chronic analgesic therapy (daily morphine ≥30 mg or equivalent dose of other opioids or tramadol or any medication for neuropathic pain)
patients with a history of drug abuse
patients with neuropsychiatric diseases; patients with a history of chronic pain syndromes that may enhance sensitivity to pain, for example, fibromyalgia
patients with a history of thoracic surgery through lateral thoracotomy; and patients with recurrent chest malignancies within 3 months.
All patients who developed severe intra- or post-operative bleeding or required postoperative mechanical ventilation were also excluded from the study.
Thoracic spine disorders or deformity.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Abdelfattah, M.Sc
Phone
1222332541
Ext
+20
Email
Dr.ahmed.sha3ban@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data will be available under a reasonable request from the author
IPD Sharing Time Frame
One year after the study is ended
Learn more about this trial
Impact of Thoracic Epidural Versus Serratus Anterior Plane Block Versus Erector Spinae Plane Block on Incidence of PTPS
We'll reach out to this number within 24 hrs