- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369323
Erector Spinae Plane Block in Kidney Transplant Pain Management
Erector Spinae Plane Block for Postoperative Pain After Kidney Transplantation: A Prospective Study"
Use of postoperative analgesia in kidney transplant recipients has always been challenging due to several issues: potential nephrotoxicity of nonsteroidal anti- inflammatory drugs and the reduced clearance of morphine metabolites due to transient renal impairment.Moreover, many patients with end-stage renal disease on dialysis are hepatitis C or hepatitis B virus positive, and the use of other effective analgesics, such as acetaminophen, is limited.The use of regional analgesia methods for postoperative analgesia can also be a useful option for more adequate control in these patients. Currently, methods of fascial trunk nerve blocks (including rectus sheath block, different types of transversus abdominis plane block, and erector spinae plane [ESP] block) have been shown to be effective components of multimodal anesthesia in various fields of surgery.In this study, investigators evaluated the effectiveness of ESP block in the postoperative period after kidney transplant.The aim of this prospective, randomized controlled trial is to evaluate the effects of erector spinae plane block on postoperative analgesia quality, opioid consumption, and side effect profile in kidney transplant patients.The study included a total of 40 patients aged 18-65 years with ASA physical status II-III who were scheduled for elective kidney transplantation. All patients received standard general anesthesia. Anesthesia induction was achieved with propofol (2-2.5 mg/kg), fentanyl (1-2 µg/kg), and rocuronium (0.6 mg/kg). Anesthesia maintenance was provided with 6% desflurane and a 50% oxygen-air mixture.ESPB Group: USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)
- Control Group: no block applied
- All patients received standard postoperative analgesia protocol. Intravenous paracetamol (1 g/8 hours) was given. Intravenous tramadol (100 mg) was administered as rescue analgesic when VAS ≥ 4.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Istanbul, Turkey (Türkiye)
- Kartal Dr Lutfi Kırdar City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All patients had end-stage renal disease due to chronic glomerulonephritis _ physical status of class 3 on American Society of Anesthesiologists classification.
Exclusion Criteria:
- ASA 4
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control group
tandard postoperative analgesia protocol was applied.
Intravenous paracetamol (1 g/8 hours) was administered.
ESP block not implemented
|
USG-guided unilateral ESP block at T9 level (0.25% bupivacaine 20 ml)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperrative VAS scores at 24 hours
Time Frame: postoperative 24 hours
|
Postoperative Vas scores at 15 minutes, 1 hour, 2 hours, 6 hours, 12 hours, and 24 hours
|
postoperative 24 hours
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Nervous System Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Renal Insufficiency
- Agnosia
Other Study ID Numbers
- 514/250/6
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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