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
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 .
The patients will randomised into 2 groups. There are 2 groups of patients: TEA combined with
GA or bilateral erector spinae block combined with G. In TEA group, patients will receive
TEA, an epidural catheter will be placed at the T7-8 interspace after 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. A
left-sided, double-lumen thoracostomy tube will be inserted and confirmed by
bronchofiberoscopy. 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 and a high-frequency linear ultrasound transducer (GE LOGIQe, Wauwatosa, Wisconsin)
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
(EchoStim; Benlan Inc, Oakville, Canada) 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 .
Hemodynamics as heart rate, arterial blood pressure, central venous pressure and oxygen
saturation will be monitored intraoperatively. The heart rate and arterial blood pressure
will be maintained within 20% of the preoperative values.
At the end of the procedure, in both groups, anesthesia will be discontinued and
neuromuscular blockade will be antagonized with neostigmine, intravenous (0.05 mg/kg) and
atropine intravenous (0.03 mg/kg) at appropriate doses.
The patients will be transported postoperatively to the intensive care unit. if VAS > 5 ,
Patient-controlled analgesia using elastomeric pump will be established with IV doses of
morphine in the erector group (basal rate about 0.5mg/h to 1 mg/h and bolus dose of 2 mg ,
300 mL maximum dose) and epidural analgesia in the TEA group (top up doses of about 4 ml of
bupivacaine 0.125% + morphine 20 μg/mL, bolus doses 2 mL to 3 mL, 300 ml maximum dose). The
patients will be monitored in the postanaesthesia care unit (PACU)
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01012232 -
Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
|
Phase 4 |