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There are limited studies comparing these two modalities ( thoracic epidural and erector spine block) for relieving the pain after thoracic surgeries .this study aim to investigate this purpose
The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator. Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation. Because the needle injection of ESPB and TEB are very close, participants themselves could hardly detect the clinical differences. Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals. Only the random sequence number rather than the specific nerve block type will be recorded in the electronic anaesthesia information management system .Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEB GROUP | Active Comparator | In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with Fentanyl 1 μg/ml.]. |
|
| ESPB group | Active Comparator | In group ESPB, The ESP block will be performed as described by Forero et al. A Tuohy needle will be inserted with an in-plane technique in a caudal to cephalad direction until bony contact with the transverse process is obtained. Hydro dissection with normal saline will be performed to identify and open up the correct plane for injection. A loading dose of Bupivacaine will be injected followed by the insertion of an 18-g catheter 5 cm beyond the needle tip. No further local anaesthetic will be administered intra-operatively. Following the end of surgery, a continuous infusion of 5 ml/h of Bupivacaine 0.125%, supplemented by a 10-ml bolus injection every 3 h, will be administered through the ESPB catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THORACIC EPIDURAL BLOCK | Other | In group TEB, The epidural catheter will be inserted preoperatively at the T5-T7 vertebral level; the exact level will be at the discretion of the attending anaesthesiologist. A loading dose of bupivacaine 0.25% (max 10 ml) will be administered, followed by an intraoperative infusion of bupivacaine 0.125 % with fentanyl 1 μg/ml.]. |
| Measure | Description | Time Frame |
|---|---|---|
| MORPHINE CONSUMPTION | cumulative 24 h opioid (morphine) consumption | 24 hours |
| Numeric rating scale | is an 11-point scale scored from 0-10:
| 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time for first rescue analgesia | Time for first rescue analgesia will be measured and recorded | 24 hours |
| The number of rescue analgesics | the number of rescue analgesics within 24hrs after surgery will be recorded |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AMAL G SAFAN, MD | Menoufia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menoufia university | Cairo | Shibin Elkom | 23535 | Egypt |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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Participants will be randomly divided into two groups according to the 1:1 ratio of ESPB group and TEB group. A research coordinator is designated to distribute and preserve randomization result. The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug
Not provided
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The random sequence will be sealed in consecutively numbered opaque envelopes and kept by the study coordinator.
Participants will be randomly divided into two groups . The coordinator will open the envelopes for allocation according to the order of enrolment and prepare the study drug.
The participants will be blinded to the allocation.Anaesthesiologists who perform the nerve block and take charge of intraoperative management and surgeons are independent individuals.Researchers who do not take part in the nerve block and intraoperative management are designated to postoperative follow-up. Besides, trained anaesthesiologist who do not perform the block will be designated to evaluate the clinical features of the block objectively
|
|
| ERECTOER SPINE BLOCK | Other | The ESP block will be performed as described by Forero et al |
|
|
| 24 hours |
| Time to ambulation | Time to ambulation WILL BE RECOREDED | 24 hours |
| Complications | Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded. | 24 hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |