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

NCT03533426 | Completed

• 1 other identifier: Raafat-Ehab.serratus
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Neuritis

Outcome Measures

Primary Outcomes (1)

• 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 .

  changes in 4 and 12 weeks .

Secondary Outcomes (2)

• Assessment of patient daily activity and functional capacity.

  changes in 4 and 12 weeks .

• Assessment of patient's quality of life.

  changes in 4 and 12 weeks .

Study Arms (2)

Pump based patient controlled analgesia

ACTIVE COMPARATOR

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

serratus anterior plane catheter block

ACTIVE COMPARATOR

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

Interventions

Serratus anterior plane catheter block PROCEDURE

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.

serratus anterior plane catheter block

Patient controlled analgesia PROCEDURE

The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome

Pump based patient controlled analgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

Department of Anesthesia and Pain medicine.National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• preventing and treating pain after thoracic surgery

MeSH Terms

Interventions

Analgesia, Patient-Controlled

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Ehab H Shaker, MD

  National Cancer Institute- Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: the data collector will be blinded to the study groups
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 23, 2018
• Study Start: March 27, 2018
• Primary Completion: July 15, 2018
• Study Completion: July 15, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)