Post Operative PainQLBNCT04963816
Pediatric Postoperative Analgesia With Quadratus Lumborum Block(QLB) And Dexamethasone As An Adjuvant To Bupivacaine.
A study testing ultrasound guided quadratus lumborum block, Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously and Bupivacaine Injection in people with Post Operative Pain and Quadratus Lumborum Block, run by Tanta University at 1 site in Egypt.
Trial summary
Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Quadratus Lumborum Block, Pediatric
- What is being tested?
- ultrasound guided quadratus lumborum block, Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously and Bupivacaine Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2021to 10 Jan 2022
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients(6-12 years)
- ASA physical status I,II
- Abdominal surgery
Who cannot join
- Parents refusal or legal guardian's refusal
- Allergy to bupivacaine or dexamethasone
- Contraindications to regional techniques
- Failed QLB
- Infection on site of procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial
Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries
Read the detailed description
After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes.
Anesthetic Technique:
Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure.
- After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups.
The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected.
Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).
- Being tested
- ultrasound guided quadratus lumborum block, Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously, Bupivacaine Injection, Dexamethasone Phosphate 4 MG/ML Injectable Solution locally
- Keywords
- Quadratus lumborum block in pediatrics, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided quadratus lumborum blockProcedure or surgery
Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenouslyDrug
Also called Dexamethasone as an adjuvant intravenously
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A
Bupivacaine InjectionDrug
Also called Light marcaine
Bupivacaine will be given to all groups locally with QLB
Dexamethasone Phosphate 4 MG/ML Injectable Solution locallyDrug
Also called Dexamethasone as an adjuvant locally
Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B
| Study group | Role | What they receive |
|---|---|---|
| Group A Quadratus Lumborum Block with dexamethasone IV | Active comparator | QLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline Receives: Procedure: ultrasound guided quadratus lumborum block; Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously; Drug: Bupivacaine Injection |
| Group B Quadratus Lumborum Block with dexamethasone locally | Active comparator | QLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline Receives: Procedure: ultrasound guided quadratus lumborum block; Drug: Bupivacaine Injection; Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locally |
| Group C Quadratus Lumborum Block with bupivacaine alone | Placebo comparator | Patients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline. Receives: Procedure: ultrasound guided quadratus lumborum block; Drug: Bupivacaine Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
Measured: 24 hours
The duration of analgesia
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.
Measured: 24 hours
Secondary outcomes (2)
The total amount of paracetamol doses
paracetamol doses (15 mg/kg per dose) as a rescue analgesic will be needed after the onset of pain
Measured: 24 hours
Postoperative vomiting
vomiting and/or retching without expulsion of gastric content will be recorded by a nurse who will be blinded to study conditions. It will treated if vomiting occurred more than twice in 2 minutes with by granisetron
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start16 Jun 2021
- Primary completion30 Oct 2021
- Study completion10 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED ABDELAZIZ SHAMA, Tanta University
- Investigators
- AHMED A SHAMA, MD, Principal investigator, Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of MedicineSHERIF K ARAFA, MD, Study chair, ASSISTANT PROFESSOR of anesthesia and surgical ICUAMIR A EL SAYED, MD, Study chair, ASSISTANT PROFESSOR of anesthesia and surgical ICU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04963816
- Sponsor's protocol ID
- 34737/6/21
- Acronym
- QLB
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
PubMed 36288584
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04963816
- Acronym / sponsor ID
- QLB / 34737/6/21
- Keywords
- Quadratus lumborum block in pediatrics, Dexamethasone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 30 Oct 2021 (actual)
- Study completion
- 10 Jan 2022 (actual)
- First posted
- 15 Jul 2021 (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.
Studying the post-operative analgesic effect of dexamethasone as an adjuvant to bupivacaine giving intravenously and locally with ultrasound guided quadratus lumborum block(QLB) in pediatrics undergoing abdominal surgeries
Detailed description
After obtaining written informed consent from parents or guardians of all patients, 90 patients (6-12 years old) scheduled for abdominal surgeries operations will be included. Patients will be randomly allocated into three groups, 30 patients in each group. Randomization will be based on computer-generated codes maintained in sequentially numbered opaque envelopes.
Anesthetic Technique:
Anesthesia will be induced with Sevoflurane plus fentanyl (0.5µg/kg) and tracheal intubation will be facilitated with Rocuronium (0.4 mg/kg). Anesthesia will be maintained with Sevoflurane (will be adjusted according to A line autoregressive index (AAI)) and Rocuronium (0.1 mg/kg/dose will be given on the basis of train-of-four neuromuscular monitoring). ECG, noninvasive blood pressure, heart rate, temperature, oxygen saturation, and exhaled CO2 (end tidal CO2) will be continuously monitored during the procedure.
- After induction of anesthesia and before skin incision, a QLB will be performed in all patients in the three groups.
The procedure will be done under ultrasound guidance using curved array transducer 5-2MHz (Sonosite ultrasound system). Echogenic needle, Sono Plex Stim cannula (PAJUNK) 22 gauge and 60 mm length will be used. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The QLB block will be performed by anterior approach. The linear probe will be attached in the area of the triangle of Petit in transverse orientation in lateral abdomen in between the iliac crest and the costal margin, near the posterior axillary line. The muscle planes will be identified until visualizing the quadratus lumborum muscle, at the same plane as the psoas major muscle and the erector spinae. The needle tip is placed at the anterolateral border of the QL at its junction of QL with transversalis fascia outside the anterior layer of the thoracolumbar fascia (TLF) and fascia transversalis, and the local anesthetic will be injected.
Anesthesia will be discontinued when the wound dressing applied, and muscle relaxant will be reversed using (50ug/kg) of neostigmine and atropine (0.02mg/kg) and extubating of the patient will be done. The patient will be transferred to the postoperative care unit (POCU).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A Quadratus Lumborum Block with dexamethasone IV | Active comparator | Procedure: ultrasound guided quadratus lumborum block, Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously, Drug: Bupivacaine InjectionQLB with (0.5 mL/kg of bupivacaine 0.25%) and IV dexamethasone (0.1-0.3 mg/kg with a maximum dose 10 mg) added to 5 mL normal saline |
| Group B Quadratus Lumborum Block with dexamethasone locally | Active comparator | Procedure: ultrasound guided quadratus lumborum block, Drug: Bupivacaine Injection, Drug: Dexamethasone Phosphate 4 MG/ML Injectable Solution locallyQLB with (0.5 mL/kg of bupivacaine 0.25% plus dexamethasone 0.1 mg/kg), and IV 5 mL normal saline |
| Group C Quadratus Lumborum Block with bupivacaine alone | Placebo comparator | Procedure: ultrasound guided quadratus lumborum block, Drug: Bupivacaine InjectionPatients will receive QLB (0.5 mL/kg of bupivacaine 0.25%) and IV 5 mL normal saline. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients(6-12 years)
- ASA physical status I,II
- Abdominal surgery
Key exclusion criteria (5 listed)
- Parents refusal or legal guardian's refusal
- Allergy to bupivacaine or dexamethasone
- Contraindications to regional techniques
- Failed QLB
- Infection on site of procedure
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 |
|---|---|---|
| ultrasound guided quadratus lumborum blockUltrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach | Procedure or surgery | Group A Quadratus Lumborum Block with dexamethasone IV, Group B Quadratus Lumborum Block with dexamethasone locally, Group C Quadratus Lumborum Block with bupivacaine alone |
| Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenouslyAlso: Dexamethasone as an adjuvant intravenouslyUsing dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A | Drug | Group A Quadratus Lumborum Block with dexamethasone IV |
| Bupivacaine InjectionAlso: Light marcaineBupivacaine will be given to all groups locally with QLB | Drug | Group A Quadratus Lumborum Block with dexamethasone IV, Group B Quadratus Lumborum Block with dexamethasone locally, Group C Quadratus Lumborum Block with bupivacaine alone |
| Dexamethasone Phosphate 4 MG/ML Injectable Solution locallyAlso: Dexamethasone as an adjuvant locallyUsing dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B | Drug | Group B Quadratus Lumborum Block with dexamethasone locally |
Primary outcome
Postoperative analgesia
Time frame: 24 hours
using the Pediatric Objective Pain Scale (15), where each criterion scores 0 - 2 to give a total score 0 - 10, and a total score of less than 5 mean adequate analgesia.
The duration of analgesia
Time frame: 24 hours
the time starting from extubation until analgesia will be required as evidenced by a pain score > 4.
2 secondary outcomes
The total amount of paracetamol doses
Time frame: 24 hours
Postoperative vomiting
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 36288584Arafa SK, Elsayed AA, Hagras AM, Shama AAA. Pediatric Postoperative Pain Control With Quadratus Lumborum Block and Dexamethasone in Two Routes With Bupivacaine: A Prospective Randomized Controlled Clinical Trial. Pain Physician. 2022 Oct;25(7):E987-E998.
- Individual participant dataSharing planned: No
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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.
AHMED A SHAMA, MD principal investigator
Lecturer and consultant of anesthesia and surgical ICU in Tanta University and Faculty of Medicine
SHERIF K ARAFA, MD study chair
ASSISTANT PROFESSOR of anesthesia and surgical ICU
AMIR A EL SAYED, MD study chair
ASSISTANT PROFESSOR of anesthesia and surgical ICU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultrasound guided quadratus lumborum block, Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously and Bupivacaine Injection in people with Post Operative Pain and Quadratus Lumborum Block, run by Tanta University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative analgesia (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04963816, which also lists 1 linked publication.
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 3 Feb 2022.