Analgesic Efficacy Clinical Trial
Official title:
The Analgesic Efficacy of Erector Spinae Block in Comparison to Thoracic Epidural Anesthesia in Patients Having Transthoracic Oesophygeal Surgical Procedures
Verified date | April 2018 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
a total of 80 patients age of 36 years old to 65 years old, (ASA) physical status I and II undergoing oesophageal procedures.The patients will randomised using concealed envelope method into 2 groups, allocation of patients to either group will be done by clinician not involved in the study. There are 2 groups of patients: TEA combined with GA (TEA group) or bilateral erector spinae block combined with GA (erector group). . In TEA group, patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%. Anaesthesia will be standardised In the TEA group, an additional 4-5mL epidural doses of bupivacaine 0.25% will be administered at 1 h intervals. In the second group, patients will receive bilateral ESP block which will be performed as follows. The patient will be placed in a lateral position ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. A total of 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way without changing the position of the patient to achieve sensory block T5-T10 .
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2, 2019 |
Est. primary completion date | April 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 36 Years to 65 Years |
Eligibility |
Inclusion Criteria: 36-65 years old oesophageal procedures ASA I,II Exclusion Criteria: - cardiac dysfunction Renal or hepatic impairment patient refusal Immune disorders Allergy to local anesthetics neuromuscular disorders |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams U | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | postoperative complications | minor complications (hypotension, vomiting, urinary retention and catheter related complications) and major complications (mortality). | 24 h | |
Secondary | length of hospital stay | Recovery time from end of surgery till discharge from hospital | 15-17 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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Phase 4 |