- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07642193
Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy
Ultrasound Guided Rhomboid Intercostal Sub-serratus Plane Block Versus External Oblique Intercostal Block in Open Nephrectomy: Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
Open nephrectomy is a common surgery usually performed for malignant and non-malignant renal pathologies. Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery.
The rhomboid intercostal block has previously been used for pain management in thoracic wall surgery.
Subserratus plane block in the treatment of post-abdominal surgical pain and the combination of the two blocks was subsequently renamed the "RISS block". The nerves targeted by the RISS block include the lateral cutaneous branches of the ventral branches of the thoracic intercostal nerves, located between the rhomboid muscle and the intercostal muscles, and deep into the scapula serratus anterior muscle. RISS block provides analgesia from T4 to T9 thoracic dermatomes and has been used in postoperative pain management for thoracic surgeries and upper abdominal surgeries.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amr R Seif, MD
- Phone Number: 00201066588692
- Email: amroseifo40404@gmail.com
Study Locations
-
-
-
Cairo, Egypt, 12613
- Recruiting
- Cairo University
-
Contact:
- Amr R Seif, MD
- Phone Number: 00201066588692
- Email: amroseifo40404@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status II, III.
- Body mass index (BMI): > 20 kg/ m2 and < 35 kg/ m2.
- Patients undergoing open nephrectomy.
Exclusion Criteria:
- Patient refusal.
- BMI <20 kg/m2 and >35 kg/m2
- Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
- History of psychiatric and cognitive disorders or chronic pain.
- Contraindication to regional anesthesia e.g pre- existing peripheral neuropathies.
- Severe respiratory or cardiac disorders.
- Advanced liver or kidney disease.
- Pregnancy.
- Physical status ASA IV.
- Coagulopathy with INR ≥ 1.6: hereditary (e.g. hemophilia, fibrinogen abnormalities & deficiency of factor II) - acquired (e.g. impaired liver functions with prothrombin concentration less than 60 %, vitamin K deficiency & therapeutic anticoagulants drugs).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group (A)
Patients will receive the rhomboid intercostal subserratus plane block.
|
Patients will receive the rhomboid intercostal subserratus plane block.
|
|
Experimental: Group (B)
Patients will receive the external oblique intercostal block.
|
Patients will receive the external oblique intercostal block.
|
|
Active Comparator: Control group
Patients will not receive any interventions (IV morphine 0.1mg/kg after induction of general anesthesia).
|
Patients will not receive any interventions (Intravenous morphine 0.1mg/kg after induction of general anesthesia).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time of first request of analgesia
Time Frame: 24 hours postoperatively
|
Time of first request of analgesia will be recorded from the end of surgery till first dose of morphine administrated.
|
24 hours postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate
Time Frame: 24 hours postoperatively
|
Heart rate will be noted immediately on arrival and at 0, 4, 8, 12, 18 and 24 h postoperatively.
|
24 hours postoperatively
|
|
Mean arterial blood pressure
Time Frame: 24 hours postoperatively
|
Mean arterial blood pressure will be noted immediately on arrival and at 0, 4, 8, 12, 18 and 24 h postoperatively.
|
24 hours postoperatively
|
|
Total amount of fentanyl
Time Frame: 24 hours postoperatively
|
Fentanyl 0.5 μg / kg will be given in case of heart rate or mean arterial blood pressure ≥ 20% of the baseline
|
24 hours postoperatively
|
|
Total morphine consumption
Time Frame: 24 hours postoperatively
|
Intravenous morphine (3 mg) will be provided as rescue of analgesia.
The total amount of morphine given in 24 h will be recorded.
|
24 hours postoperatively
|
|
Degree of pain
Time Frame: 24 hours postoperatively
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").
NRS will be recorded at 30 minutes, 2,4, 8, 12, 16, 24 hours postoperatively.
|
24 hours postoperatively
|
|
Incidence of block related complications
Time Frame: 24 hours postoperatively
|
Incidence of block related complications such as local anesthetic toxicity, hematoma formation, and pneumothorax will be recorded.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
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
Other Study ID Numbers
- AP2604-501-160-209
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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