Post Operative Pain
Conditions
Brief summary
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
Detailed description
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
Interventions
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.\].
OTHERERECTOER SPINE BLOCK
The ESP block will be performed as described by Forero et al
Sponsors
Menoufia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
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
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Eligible patients will be from18-70 years old with ( American association of anaesthesiologist) ASA physical status I to III scheduled for elective thoracic surgeries.
Exclusion criteria
* Patients who are: * Unable to cooperate. * Patients who have allergy to any of the study drugs. * Patients who are on opioids. * Local infection at the site of injection or systemic infection. * Patients with coagulation disorders or on anticoagulation therapy Unable to communicate preoperatively due to severe dementia, language barrier, or neuropsychiatric disorder * Unable to perform nerve block procedure due to difficult anatomy through ultrasound scan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MORPHINE CONSUMPTION | 24 hours | cumulative 24 h opioid (morphine) consumption |
| Numeric rating scale | 24 hours | is an 11-point scale scored from 0-10: 1. 0 = no pain 2. 10 = the most intense pain imaginable Patients verbally select a value that is most in line with the intensity of pain that they have experienced in the last 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time for first rescue analgesia | 24 hours | Time for first rescue analgesia will be measured and recorded |
| The number of rescue analgesics | 24 hours | the number of rescue analgesics within 24hrs after surgery will be recorded |
| Time to ambulation | 24 hours | Time to ambulation WILL BE RECOREDED |
| Complications | 24 hours | Complications like bradycardia or hypotension, itching, nausea and vomiting will be recorded. |
Countries
Egypt
Outcome results
None listed