- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06957574
Erector Spinae Plane Block as Analgesia in Patients for Colectomy
Erector Spinae Plane Block as Analgesia in Patients for Colectomy: A Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In major abdominal surgeries, the gold standard for postoperative analgesia is thoracic epidural analgesia. Nevertheless, there are many concerns regarding its side effects, including motor blockade and hypotension. Moreover, many researchers interrogated its role as it may increase the risk of serious problems such as epidural hematoma and abscess. As an alternative, some surgeons proposed the transversus abdominis plane (TAP); however, a recent meta-analysis established that TAP block was of minimal effect.
The erector spinae plane block (ESPB) is a fairly original paraspinal plane block that was first designated for thoracic analgesia. Recently, some reports showed that it could offer effective and widespread somatic and visceral abdominal analgesia. Bilateral continuous ESP blockade represents a respected alternative to thoracic epidural analgesia. The local injection under the erector spinae muscle is carried out in this technique, which is estimated to spread a paravertebral of three vertebral levels cranially and four levels caudally. It was designated that the injected local anesthesia passes across the costotransverse foramina and blocks the ventral and dorsal rami of spinal nerves, causing a sensory blockade over the anterolateral thorax. The dermatomes enclosed by ESPB depend on the site of entry, the volume, and the concentration of the local anesthetic used. This RCT aimed to assess the analgesic effectiveness of US-guided bilateral erector spinae plane block in patients undergoing elective colectomy.
This randomized controlled trial was designed to assess the analgesic effectiveness of bilateral US-guided erector spinae plane blocks (ESPB) in patients undergoing elective colectomy surgery.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Ismailia, Egypt
- Faculty of Medicine, Suez Canal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients of colorectal carcinoma scheduled for elective colectomy
Exclusion Criteria:
- Patients with a body mass index (BMI) of 35 kg/m2 or above
- patients with a history of hepatic or renal diseases
- patients with second- or third-degree heart blocks
- patients with coagulopathies
- patients with history of hypersensitivity to local anesthetics
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ESPB
ESPB using local anaesthetic 20 ml 0.25% bupivacaine on each side
|
ESPB using local anesthetic 20 ml 0.25% bupivacaine on each side
|
|
Placebo Comparator: Saline
ESPB using normal saline 20 ml on each side
|
ESPB using normal saline 20 ml 0.25% bupivacaine on each side
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
morphine consumption
Time Frame: From the time of end of surgery till the pass of the first 24 hours postoperatively
|
postoperative total morphine consumption over 24 hours
|
From the time of end of surgery till the pass of the first 24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ESPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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