Clinical trial NCT06571188: Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia
Official title: Comparison of Ultrasound-Guided Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Postoperative Analgesia Following Thoracotomy Surgeries: a Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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

Eligibility criteria: 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.

Primary outcomes:
measure: MORPHINE CONSUMPTION
timeFrame: 24 hours
measure: Numeric rating scale
timeFrame: 24 hours
Secondary outcomes:
measure: Time for first rescue analgesia
timeFrame: 24 hours
measure: The number of rescue analgesics
timeFrame: 24 hours
measure: Time to ambulation
timeFrame: 24 hours
measure: Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Menoufia university
state: Shibin Elkom
Study officials:
affiliation: Menoufia University
name: AMAL G SAFAN, MD
role: PRINCIPAL_INVESTIGATOR
References: