Post Operative PainNCT06661707
Comparative Study Between Ultrasound Guided Quadratus Lumborum Versus Ilioingunial/ Iliohypogastric Nerves Block as Post-operative Analgesia for Patients Undergoing Inguinal Hernia Repair Surgeries
A study testing Sonar guided Quadratus Lumborum block and Sonar guided Ilioinguinal/Iliohypogastric block in people with Post Operative Pain, run by Ain Shams University.
Trial summary
Postoperative pain management is becoming an integral part of anesthesia care. Various techniques of pain relief have been designed. We have designed the study for comparison between ultrasound guided quadratus lumborum (QL) block versus Ultrasound-guided ilioinguinal and iliohypogastric nerves (ILI+IHG) block as… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Sonar guided Quadratus Lumborum block and Sonar guided Ilioinguinal/Iliohypogastric block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2024to 30 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Physical Status: ASA (American society of Anesthesiologists) I - II patients.
- undergoing inguinal hernia repair
Who cannot join
- Contraindications to QL block \& ILI+IHG nerve block such as; (Infection at site of injection, allergy to local anesthetic drugs.)
- Refusal of procedure or participation in the study by patients.
- Psychiatric illness or uncooperative patient.
- Coagulopathy, use of anticoagulants or antiplatelet therapy.
- Chronic analgesic users, drug addicts and alcoholic patients.
About this study
Postoperative pain management is becoming an integral part of anesthesia care. Various techniques of pain relief have been designed. We have designed the study for comparison between ultrasound guided quadratus lumborum (QL) block versus Ultrasound-guided ilioinguinal and iliohypogastric nerves (ILI+IHG) block as regard postoperative pain block and opioid consumption in patients undergoing inguinal hernia repair under general anesthesia.
Read the detailed description
In the anesthesia clinic, an informed written consent will be taken from every patient one day before the surgery. Explanation of the visual analogue score (VAS) will be performed. History, clinical examination and routine investigations including; complete blood count (CBC), fasting blood sugar (FBS), liver function test (LFT), kidney function test (KFT), electrocardiogram (ECG), prothrombin time (PT) and activated partial thromboplastin time (aPTT) will be performed to all patients.
In the induction room, an intravenous (IV) 20 gauge cannula will be inserted and premedication will be limited to intravenous (IV) midazolam (0.03 mg/kg).
- Intra-operative setting:
- General anesthesia technique:
The patient will be fasting for at least 8 hours preoperatively. A standardized general anesthesia protocol will be used for all patients. General anesthesia will be induced with propofol (1.5-2 mg /kg) and fentanyl (1 µg /kg) with neuromuscular block Atracurium (0.5mg/kg at induction then 0.1mg/kg as maintenance dose. The patient's airway will be maintained using an endotracheal tube. Maintenance of anesthesia will be commenced using isoflurane (1.2%) in a 50% mixture of oxygen in air.
Ventilator Settings: the ventilation will be achieved with a volume-controlled mode ventilation, respiratory rate adjusted according to EtCO2 to range between 30-35 mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air, with PEEP 5 cm H2O using a closed circle system with a total fresh gas flow rate of 3L/min.
All patients will receive Ondansetron 8mg IV as antiemetic prophylaxis. Fentanyl (0.5 µg /kg) will be given for intraoperative rescue analgesia in case of tachycardia (heart rate more than 90 bpm or more than 20% of the base line of the patient) or hypertension (blood pressure more than 139/89mmHg or more than 20% of the base line of the patient) due to intraoperative pain after exclusion of other causes of tachycardia and increased blood pressure. 1 gm paracetamol will be given 30 minutes before skin closure.
Study procedures (The intervention): (The procedure will be done by the most experienced member of the research team) The procedure will be done in the operating rooms (OR) under complete aseptic technique by the most experienced member of the research team. Patients will be randomly allocated by computer generated randomization to one of the two groups according to the used block into
Group A; Quadratus Lumborum block (QL) group Group B; Ilioinguinal/Iliohypogastric block (ILI/IHG) group
Preparations that will be used for each patient are:
- Sterile towels, sponges, 4-inch gauze packs and povidone iodine 5% for sterilization, sterile gloves and 21gauge 120mm Locoplex Sono Tap cannula (Locoplex@ VYGON, France).
- The study drugs (commercially available forms) that will be used are:
- A 20 ml vial of 0.5% (bupivacaine hydrochloride).
- A 50ml vial of 2% (Lidocaine hydrochloride).
Group A; Quadratus Lumborum block (QL) group (22 patients) :
The patient will be positioned supine with lateral tilt to perform the block, and the transducer will be placed at the level of the anterior superior iliac spine and will be moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed postero-laterally until its posterior border will be visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg.
Group B; Ilioinguinal/Iliohypogastric block (ILI/IHG) group (22 patients):
The ultrasound linear probe will be placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve will be seen medial to the ilioinguinal nerve. The overlying skin will be prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula will be advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles.
After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose of 3 mg/kg.
- Postoperative settings: At the end of the procedure, the residual neuromuscular block will be reversed with injection of neostigmine (0.05 mg/kg) with atropine (0.01 mg/kg intravenous). Endotracheal tube extubation will be done after oral and endotracheal suction, then the patient will be transferred to postoperative anesthesia care unit (PACU).
At the post-anesthesia care unit (PACU) all patients will receive standard protocol of intravenous paracetamol 1 gm every 6 hours for the following 24 hours, and rescue dose of IV pethidine 50 mg if VAS score is ≥3.
If VAS score is ≥3 after 2 hours another dose of pethidine 25mg IM will be given and repeated if VAS score remains ≥3 every 2 hours for 24 hours postoperatively.
In the surgical ward vital signs (heart rate and blood pressure) as well as pain intensity will be assessed every 2 hours for 24 hours postoperatively.
- If local anaesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 100 ml over 2-3 min will be given.
- Conditions
- Post Operative Pain
- Being tested
- Sonar guided Quadratus Lumborum block, Sonar guided Ilioinguinal/Iliohypogastric block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sonar guided Quadratus Lumborum blockProcedure or surgery
The probe will be tilted down the lateral abdomen to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg
Sonar guided Ilioinguinal/Iliohypogastric blockProcedure or surgery
The ultrasound linear probe will be placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve will be seen medial to the ilioinguinal nerve. The overlying skin will be prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula will be advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles.
After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose of 3 mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Quadratus Lumborum block (QL) group | Active comparator | Not described Receives: Procedure: Sonar guided Quadratus Lumborum block |
| Ilioinguinal/Iliohypogastric block (ILI/IHG) group | Active comparator | Not described Receives: Procedure: Sonar guided Ilioinguinal/Iliohypogastric block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to the first request of analgesia
visual analogue score ≥3 by giving pethidine (50 mg IV)
Measured: 24 hours postoperative
Secondary outcomes (2)
Total doses of analgesia
(pethidine)
Measured: 24 hours postoperative
occurence of side effects
nausea, vomiting,hypotension and bradycardia
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start30 Oct 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAMY AHMED, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661707
- Sponsor's protocol ID
- Ain Shams university S2
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ultrasound Guided Quadratus Lumborum Versus Ilioingunial/ Iliohypogastric Nerves Block as Post-operative Analgesia for Patients Undergoing Inguinal Hernia Repair Surgeries
- ClinicalTrials.gov ID
- NCT06661707
- Acronym / sponsor ID
- Ain Shams university S2
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative pain management is becoming an integral part of anesthesia care. Various techniques of pain relief have been designed. We have designed the study for comparison between ultrasound guided quadratus lumborum (QL) block versus Ultrasound-guided ilioinguinal and iliohypogastric nerves (ILI+IHG) block as regard postoperative pain block and opioid consumption in patients undergoing inguinal hernia repair under general anesthesia.
Detailed description
In the anesthesia clinic, an informed written consent will be taken from every patient one day before the surgery. Explanation of the visual analogue score (VAS) will be performed. History, clinical examination and routine investigations including; complete blood count (CBC), fasting blood sugar (FBS), liver function test (LFT), kidney function test (KFT), electrocardiogram (ECG), prothrombin time (PT) and activated partial thromboplastin time (aPTT) will be performed to all patients.
In the induction room, an intravenous (IV) 20 gauge cannula will be inserted and premedication will be limited to intravenous (IV) midazolam (0.03 mg/kg).
- Intra-operative setting:
- General anesthesia technique:
The patient will be fasting for at least 8 hours preoperatively. A standardized general anesthesia protocol will be used for all patients. General anesthesia will be induced with propofol (1.5-2 mg /kg) and fentanyl (1 µg /kg) with neuromuscular block Atracurium (0.5mg/kg at induction then 0.1mg/kg as maintenance dose. The patient's airway will be maintained using an endotracheal tube. Maintenance of anesthesia will be commenced using isoflurane (1.2%) in a 50% mixture of oxygen in air.
Ventilator Settings: the ventilation will be achieved with a volume-controlled mode ventilation, respiratory rate adjusted according to EtCO2 to range between 30-35 mmHg, a tidal volume of 6-8 ml/kg and mixture of gases in proportion 50% oxygen and 50% air, with PEEP 5 cm H2O using a closed circle system with a total fresh gas flow rate of 3L/min.
All patients will receive Ondansetron 8mg IV as antiemetic prophylaxis. Fentanyl (0.5 µg /kg) will be given for intraoperative rescue analgesia in case of tachycardia (heart rate more than 90 bpm or more than 20% of the base line of the patient) or hypertension (blood pressure more than 139/89mmHg or more than 20% of the base line of the patient) due to intraoperative pain after exclusion of other causes of tachycardia and increased blood pressure. 1 gm paracetamol will be given 30 minutes before skin closure.
Study procedures (The intervention): (The procedure will be done by the most experienced member of the research team) The procedure will be done in the operating rooms (OR) under complete aseptic technique by the most experienced member of the research team. Patients will be randomly allocated by computer generated randomization to one of the two groups according to the used block into
Group A; Quadratus Lumborum block (QL) group Group B; Ilioinguinal/Iliohypogastric block (ILI/IHG) group
Preparations that will be used for each patient are:
- Sterile towels, sponges, 4-inch gauze packs and povidone iodine 5% for sterilization, sterile gloves and 21gauge 120mm Locoplex Sono Tap cannula (Locoplex@ VYGON, France).
- The study drugs (commercially available forms) that will be used are:
- A 20 ml vial of 0.5% (bupivacaine hydrochloride).
- A 50ml vial of 2% (Lidocaine hydrochloride).
Group A; Quadratus Lumborum block (QL) group (22 patients) :
The patient will be positioned supine with lateral tilt to perform the block, and the transducer will be placed at the level of the anterior superior iliac spine and will be moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed postero-laterally until its posterior border will be visualized (hook sign), leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg.
Group B; Ilioinguinal/Iliohypogastric block (ILI/IHG) group (22 patients):
The ultrasound linear probe will be placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve will be seen medial to the ilioinguinal nerve. The overlying skin will be prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula will be advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles.
After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose of 3 mg/kg.
- Postoperative settings: At the end of the procedure, the residual neuromuscular block will be reversed with injection of neostigmine (0.05 mg/kg) with atropine (0.01 mg/kg intravenous). Endotracheal tube extubation will be done after oral and endotracheal suction, then the patient will be transferred to postoperative anesthesia care unit (PACU).
At the post-anesthesia care unit (PACU) all patients will receive standard protocol of intravenous paracetamol 1 gm every 6 hours for the following 24 hours, and rescue dose of IV pethidine 50 mg if VAS score is ≥3.
If VAS score is ≥3 after 2 hours another dose of pethidine 25mg IM will be given and repeated if VAS score remains ≥3 every 2 hours for 24 hours postoperatively.
In the surgical ward vital signs (heart rate and blood pressure) as well as pain intensity will be assessed every 2 hours for 24 hours postoperatively.
- If local anaesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 100 ml over 2-3 min will be given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quadratus Lumborum block (QL) group | Active comparator | Procedure: Sonar guided Quadratus Lumborum block |
| Ilioinguinal/Iliohypogastric block (ILI/IHG) group | Active comparator | Procedure: Sonar guided Ilioinguinal/Iliohypogastric block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Physical Status: ASA (American society of Anesthesiologists) I - II patients.
- undergoing inguinal hernia repair
Key exclusion criteria (5 listed)
- Contraindications to QL block \& ILI+IHG nerve block such as; (Infection at site of injection, allergy to local anesthetic drugs.)
- Refusal of procedure or participation in the study by patients.
- Psychiatric illness or uncooperative patient.
- Coagulopathy, use of anticoagulants or antiplatelet therapy.
- Chronic analgesic users, drug addicts and alcoholic patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sonar guided Quadratus Lumborum blockThe probe will be tilted down the lateral abdomen to identify a bright hyperechoic line that represents the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of (0.2 mL/kg of 0.25% bupivacaine per side) will be applied without exceeding the toxic dose 3 mg/kg | Procedure or surgery | Quadratus Lumborum block (QL) group |
| Sonar guided Ilioinguinal/Iliohypogastric blockThe ultrasound linear probe will be placed over the anterior superior iliac spine with the superior margin of the transducer pointed directly in an oblique plane toward the umbilicus. The iliohypogastric nerve will be seen medial to the ilioinguinal nerve. The overlying skin will be prepared with antiseptic solution and 21 gauge 120mm Locoplex Sono Tap cannula will be advanced using an in-plane approach from a point just below the inferior border of the transducer toward the ilioinguinal nerve as it lies within the facial plane between the internal abdominal oblique and transverse abdominis muscles. After negative aspiration, (0.2 mL/kg of 0.25% bupivacaine per side) will be injected without exceeding the toxic dose of 3 mg/kg | Procedure or surgery | Ilioinguinal/Iliohypogastric block (ILI/IHG) group |
Primary outcome
The time to the first request of analgesia
Time frame: 24 hours postoperative
visual analogue score ≥3 by giving pethidine (50 mg IV)
2 secondary outcomes
Total doses of analgesia
Time frame: 24 hours postoperative
occurence of side effects
Time frame: 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sonar guided Quadratus Lumborum block and Sonar guided Ilioinguinal/Iliohypogastric block in people with Post Operative Pain, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to the first request of analgesia (time frame: 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.