Ultrasound-guided Serratus Block and the Emergence of Post-thoracotomy Pain Syndrome
|ClinicalTrials.gov Identifier: NCT03533426|
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Neuritis||Procedure: Serratus anterior plane catheter block Procedure: Patient controlled analgesia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||the data collector will be blinded to the study groups|
|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|
|Actual Study Start Date :||March 27, 2018|
|Actual Primary Completion Date :||July 15, 2018|
|Actual Study Completion Date :||July 15, 2018|
Active Comparator: Pump based patient controlled analgesia
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.
Procedure: Patient controlled analgesia
The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome
Active Comparator: serratus anterior plane catheter block
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.
Procedure: Serratus anterior plane catheter block
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.
- Assessment for the possible emergence of post - thoracotomy pain syndrome . [ Time Frame: changes in 4 and 12 weeks . ]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 .
- Assessment of patient daily activity and functional capacity. [ Time Frame: changes in 4 and 12 weeks . ]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. [ Time Frame: changes in 4 and 12 weeks . ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533426
|Department of Anesthesia and Pain medicine.National Cancer Institute|
|Cairo, Egypt, 11796|
|Principal Investigator:||Ehab H Shaker, MD||National Cancer Institute- Cairo University|