- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06403020
Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block
Ultrasound-guided Quadratus Lumborum Block Versus Rectus Sheath Block in Paraumbilical Hernia in Adults: A Prospective Randomized Study
Study Overview
Status
Intervention / Treatment
Detailed Description
patients will be allocated randomly into two groups by a computer generated sequence using closed envelope method. Group Q (n=23) will have qadratus lumboroum (QL) block.
Group R (n=23) will have rectus sheath (RS) block. Surgery will be performed by the same surgeon and the block also will be done by same anesthesiologist who will not be involved in postoperative assessment.
All patients will have a preoperative history taking, clinical examination and routine preoperative laboratory investigations will be done. Patients also will be learned how to deal with the VAS score before surgery. The visual analog scale (VAS) is a pain score at which a 10-cm line with two ends "no pain" on the left end and the "worst pain" on the right end, used to track pain for a patient or to compare pain between patients.(12,13) At operating room (OR), patients will be monitored by noninvasive blood blood pressure(NABP), peripheral oxygen saturation (spo2) and and electrocardiogram ( ECG). A peripheral intravenous cannula will be inserted. Patients will be premedicated by midazolam (1-2 mg), and they will be pre oxygenated 3-5 minutes before induction of anesthesia. General anesthesia will be given using propofol 2-3mg/kg intravenous(IV), fentanyl 1-2µg/kg IV and atracurium 0.5 mg/kg IV as a muscle relaxant to facilitate intubation. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Patients will be mechanically ventilated with 50% O2 and 50% air keeping end-tidal CO2 between 30 - 35 mmHg. Fentanyl bolus doses of 0.5-1 mcg/kg will be given according to the changes of hemodynamic variables more than 20% base line).
After the end of the surgery, and by the use of (Philips clear vue350, Philip Healthcare, Andover MAO1810, USA) ultrasound probe to perform the block according to the patient group.
Group Q: patients will receive qadratus lumborum block. The procedure will be performed under complete aseptic conditions, in the supine position, with slight elevation of the ipsilateral pelvis using a high frequency probe (5---10 MHz),connected to an ultrasound unit in transverse orientation. the probe will be positioned transversely at the anterosuperior iliac spine (ASIS) and it will be moved cranially to visualize the three muscle layers of the abdominal wall. After identifying the external oblique muscle, the probe will be moved posterolaterally to find its posterior border (hook sign) with the internal oblique muscle below it forming a roof above the quadratus lumborum muscle. By tilting the transducer down, the middle layer of the thoracolumbar fascia will be seen as a bright hyperechoic line. A 21-gauge Stimuplex® A 100-mm needle (B. Braun Melsungen AG, Germany) will be inserted in-plane in the anterolateral-to-posteromedial direction. After negative aspiration 0.2-0.4 ml/kg of bupivacaine 0.25% will be injected slowly on each side. Group R: patients will receive rectus sheath block. Under complete antiseptic condition,the rectus muscle will be identified using a high frequency linear probe with a transverse orientation placed across the abdomen above the level of the umbilicus. Starting with the midline, the linea alba and rectus muscle on either side will be identified. The rectus sheath will appear as hyperechoic fascial plane encircling the rectus abdominis muscle. Using an in-plane technique, the needle (100-mm needle ) will be passed through the rectus abdominal muscle to reach the plane between it and the posterior rectus sheath. After negative aspiration 0.2-0.4 ml/kg of bupivacaine 0.25% will be injected slowly on each side, local anaesthetic will be seen peeling the rectus muscle off the posterior rectus sheath.
At the end of surgery, all anesthetics will be stopped, reversal of muscle relaxants will be given, patients will be extubated when they will able to breath spontaneously with adequate tidal volume. Patients will be transferred to postanesthesia care unit (PACU). All patients will receive paracetamol 1gm/kg every 8 hours. All treating and outcome assessors staff will be blinded to the group allocation of the patients. At the recovery room, patients will assess their pain using VAS score, and they will be monitored for postoperative pain. Patients will be transferred to the ward and will leave the post anesthesia care unit (PACU) with Aldrete score more than 9. (14) patient with Vas score ≥4, will recieve a rescue dose of morphine 3-5 mg IV.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Fayoum, Egypt, 63511
- Fayoum University hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients 18-60 years old,
- American Society of Anesthesiology (ASA) I, Ⅱ,
- both sexes who will have PUH surgical repair under general anesthesia.
Exclusion criteria:
- Known allergy to any of the drugs that will be used in the study.
- Coagulation disorders.
- Infection at the site of injection.
- Liver or kidney disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group Q
Group Q (n=23) will have a qadratus lumboroum (QL) block.
|
qadratus lumboroum (QL) block
|
|
Active Comparator: Group R
Group R (n=23) will have a rectus sheath (RS) block.
|
qadratus lumboroum (QL) block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue score
Time Frame: The first 24 hours postoperative
|
Postoperative pain
|
The first 24 hours postoperative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Age
Time Frame: 1 year
|
Demographic data
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Karaarslan E, Topal A, Avci O, Tuncer Uzun S. Research on the efficacy of the rectus sheath block method. Agri. 2018 Oct;30(4):183-188. doi: 10.5505/agri.2018.86619.
- 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. Erratum In: Anesthesiology. 2024 Dec 1;141(6):1226. doi: 10.1097/ALN.0000000000005221.
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
Other Study ID Numbers
- R321.
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
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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