- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07787221
QL Block Versus EO Plane Block for Analgesia After Open Nephrectomy
Quadratus Lumborum Block Versus External Oblique Plane Block for Analgesia After Open Nephrectomy: A Prospective Randomized Clinical Trial
This prospective randomized clinical trial aims to compare two ultrasound-guided regional anesthesia techniques, the transmuscular quadratus lumborum (QL) block and the external oblique (EO) plane block, for pain relief after open nephrectomy. Open nephrectomy is a major surgical procedure that can cause significant postoperative pain and may require opioid medications for adequate pain control.
Adult patients undergoing open nephrectomy at the National Cancer Institute, Cairo University, who meet the study eligibility criteria will be randomly assigned to receive either a QL block or an EO plane block before surgery. Both techniques will be performed under ultrasound guidance using bupivacaine in addition to standardized general anesthesia and multimodal postoperative analgesia.
The main purpose of the study is to determine whether the QL block provides better postoperative analgesia than the EO plane block. The primary outcome will be the total amount of intravenous morphine consumed during the first 24 hours after surgery. Secondary outcomes will include postoperative pain scores, time to first request for rescue analgesia, hemodynamic changes, recovery time, patient satisfaction, and adverse effects related to analgesia or the regional anesthesia techniques.
A total of 54 patients will be enrolled and randomly allocated equally between the two treatment groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The study is a prospective, randomized clinical trial designed to compare the analgesic efficacy of the transmuscular quadratus lumborum block with the external oblique plane block in adult patients undergoing open nephrectomy.
Open nephrectomy is associated with substantial postoperative pain because of the extent of the surgical incision, muscular dissection, and manipulation of retroperitoneal structures. Effective postoperative analgesia is important to facilitate recovery, mobilization, respiratory function, and patient comfort while minimizing opioid requirements.
The quadratus lumborum block is a posterior abdominal wall fascial plane block in which local anesthetic is deposited in relation to the quadratus lumborum muscle. The technique may provide analgesia over several thoracoabdominal dermatomes and may have both somatic and visceral analgesic effects. The external oblique plane block is a more superficial fascial plane technique that targets the lateral abdominal wall and may provide effective somatic analgesia.
Eligible patients will be randomly allocated in a 1:1 ratio to receive either a transmuscular QL block or an EO plane block before induction of general anesthesia. All patients will receive standardized general anesthesia and multimodal postoperative analgesia. The regional blocks will be performed under ultrasound guidance by an experienced anesthesiologist.
The primary outcome is total intravenous morphine consumption during the first 24 postoperative hours. Secondary outcomes include pain intensity at predefined postoperative time points, both at rest and with movement; time to first request for rescue analgesia; intraoperative and postoperative hemodynamic changes; recovery time; patient satisfaction; and adverse effects, including nausea, vomiting, respiratory depression, and complications related to the regional anesthesia technique.
The study will evaluate whether the QL block provides superior postoperative analgesia and opioid-sparing effects compared with the EO plane block following open nephrectomy.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: sayed M Abed, MD
- Phone Number: 002-01226806532
- Email: sayed.abed@nci.cu.edu.eg
Study Contact Backup
- Name: Nourhan R Ali Hassan, Master's
- Phone Number: 002-01200858194
- Email: nourhanrabeaali@gmail.com
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo university
-
Contact:
- sayed M Abed, MD
- Phone Number: 002-01226806532
- Email: sayed.abed@nci.cu.edu.eg
-
Contact:
- Nourhan R Ali Hassan, Master's
- Phone Number: 002-01200858194
- Email: nourhanrabeaali@gmail.com
-
Cairo, Egypt, 11796
- Recruiting
- Cairo university
-
Contact:
- sayed M Abed, MD
- Phone Number: 002-01226806532
- Email: sayed.abed@nci.cu.edu.eg
-
Contact:
- Nourhan R Ali Hassan, Master's
- Phone Number: 002-01200858194
- Email: nourhanrabeaali@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Adult patients aged 18 to 65 years. Patients undergoing open nephrectomy at the National Cancer Institute, Cairo University.
American Society of Anesthesiologists (ASA) physical status II-III. Body mass index (BMI) greater than 20 kg/m² and less than 35 kg/m².
Exclusion Criteria:
Patient refusal to participate. ASA physical status IV. Age less than 18 years or greater than 65 years. BMI less than 20 kg/m² or greater than 35 kg/m². Known allergy or contraindication to any study medication, including local anesthetics or opioids.
History of psychiatric disorders or chronic pain. Contraindications to regional anesthesia, including local infection at the injection site, pre-existing neuropathy, or coagulopathy.
Severe organ dysfunction, including cardiac dysfunction (ejection fraction <40%), respiratory dysfunction (FEV1 <50% of predicted or requirement for home oxygen therapy), hepatic dysfunction (Child-Pugh class C), or renal dysfunction (estimated glomerular filtration rate <30 mL/min/1.73 m²).
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 |
|---|---|
|
Experimental: Quadratus Lumborum Block (QL)
Participants will receive an ultrasound-guided transmuscular quadratus lumborum block before induction of general anesthesia.
A total of 30 mL of 0.25% bupivacaine will be administered in the fascial plane between the quadratus lumborum and psoas major muscles.
Participants will also receive the standardized general anesthesia and postoperative multimodal analgesia described in the study protoco
|
Ultrasound-guided transmuscular quadratus lumborum block using 30 mL of 0.25% bupivacaine administered before induction of general anesthesia.
|
|
Experimental: External Oblique Plane Block (EO)
Participants will receive an ultrasound-guided external oblique plane block before induction of general anesthesia.
A total of 30 mL of 0.25% bupivacaine will be administered in the fascial plane between the external oblique and intercostal muscles.
Participants will also receive the standardized general anesthesia and postoperative multimodal analgesia described in the study protocol.
|
Ultrasound-guided external oblique plane block using 30 mL of 0.25% bupivacaine administered before induction of general anesthesia.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
24-hour postoperative morphine consumption
Time Frame: First 24 hours after surgery
|
Total amount of intravenous morphine administered as rescue analgesia during the first 24 hours after surgery.
Morphine consumption will be recorded for each participant and compared between the quadratus lumborum block and external oblique plane block groups.
|
First 24 hours after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mona H Abdelhamid, MD, Professor of anesthesia
Publications and helpful links
General Publications
- Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.
- Blanco R. TAP block under ultrasound guidance: the description of a "non-pops technique." Reg Anesth Pain Med. 2007;32(2):130.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
- QL block vs EOB in nephrectomy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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