Post-operative PainPhase 1NCT07023991
Dexmedetomidine Added to Bupivacaine for ESP Block in Children Undergoing Lower Abdominal Surgeries
A Phase 1 study testing Bupivacaine and Dexmedetomidine in people with Post-operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Bupivacaine and Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2025to 31 Aug 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Pediatric patients aging 1-7 years old of both sexes.
- Patients scheduled for unilateral or bilateral lower abdominal surgeries.
- American Society of Anesthesiologists (ASA) Physical Status Class I, II
Who cannot join
- Parents or legal guardian refusal of participation in the study.
- Contraindication to regional anesthesia (including coagulopathy and local infection).
- History or known allergy to local anesthetics.
- Past history of any complications related to the block. (including hematoma and intravascular injection)
- Spinal anomalies altered mental status, a history of developmental delay.
- Additional surgical procedures at different surgical sites.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Adding Dexmedetomidine to Bupivacaine in US- Guided Erector Spinae Plane Block for Post-operative Pain Management in Pediatric Patients Undergoing Lower Abdominal Surgeries
This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes.
In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores
Read the detailed description
- Preoperative setting:
- A careful history taking will be done from the parents of the child for any medical disorder such as congenital coagulation disorders or therapeutic anticoagulants.
- A complete physical examination of the child will be done, including the central nervous system for signs of mental disturbance, the chest for any deformities or chest infection, the heart for congenital heart disease, and the back for any spinal deformities or infection at the site of injection.
- Routine preoperative investigations will be done to all patients, including laboratory investigations (complete blood picture, liver and kidney function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition.
- Written informed consent will be obtained from all participants' parents or legal guardian prior to the study.
- Intraoperative setting:
- All children will be premedicated orally with midazolam (0.05-0.1 mg/kg over 2-3 minutes, maximum 6 mg) 30 minutes prior to surgery. On arrival of the patients to the operative room, routine monitoring with 5-leads electrocardiogram (ECG), non-invasive blood pressure (NIBP) and pulse oximetry will be instituted, then anesthesia will be induced with 8% sevoflurane in 100% oxygen. After an adequate depth of anesthesia is reached, an intravenous access will be placed under aseptic condition, then all patients will receive intravenous (IV) fentanyl (1 µg/kg) and atracurium (0.5 mg/kg), and orotracheal endotracheal intubation will be performed. Anesthesia will be maintained with a mixture of oxygen-air (50% - 50%) and isoflurane
- -1.5%). Muscle relaxation will be sustained during the procedure with incremental doses of IV atracurium (0.1 mg/kg) every 25 minutes. In group A: US guided ESPB will be performed with aseptic precautions using a (6- 19) MHz linear probe in a sterile cover with sterile jelly (GE LOGIQ 5, USA).
- Technique of US guided ESPB block: The block will be performed by a trained anesthetist in regional anesthetic techniques while the patient in lateral position, the ultrasound transducers will be placed in a parasagittal plane 2-3 cm away from the midline at the level of first lumbar vertebra (L1) (The L1 level will be identified by counting upwards from the sacrum). Sliding the transducer medially till identifying the transverse process which appear as flat acoustic shadow and after identification of erector spinae muscle (ESM) and transverse process, a 22-gauge 50 mm echogenic block needle (Sono Plex® PAJUNK®, Germany) will be introduced in cranio-caudal direction with in-plane technique and after confirming the position of the tip of the needle over the transverse process with negative aspiration to blood or air, Bupivacaine 0.25% (with a maximum dose 2 mg/kg) plus Dexmedetomidine (0.5µg/kg), putting into consideration that the total volume to be 0.3 ml/kg on each side, will be injected. The spread of local anesthetic in a plane below the erector spinae muscle will be visualized.
- The skin incision will be made 15 min after the block.
- Baseline values of heart rate (HR) and mean blood pressure (MAP) will be recorded before skin incision and then recorded at 5, 30, 60 minutes after skin incision and at the end of surgery. Also, patients will be monitored for sign of local anesthetic toxicity.
- Any complications related to the block given will be recorded including hematoma, intravascular injection, and allergic reactions.
- If local anesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 1.5 ml/kg over 2-3 min will be given.
In group B: This group will receive ESPB using Bupivacaine 0.25% (with a maximum dose 2 mg/kg) alone 15 min before skin incision with the same protocol and precautions.
- In both group an increase in heart rate to 20% above the baseline values at any time during the procedure will be defined as insufficient analgesia and fentanyl 0.5 µg/kg will be given and the total amount of intraoperative opioid will be recorded.
- At the end of the surgery Isoflurane will be discontinued and neostigmine 0.05 mg/kg plus atropine 0.02 mg/kg will be administered to reverse the effect of atracurium. After awakening from anesthesia and achieving an appropriate level of consciousness, the patient will be discharged from the operating room to be transferred to the PACU (Post Anesthesia Care Unit), and pain assessment will be done immediate post extubating.
Postoperative setting:
- Postoperative pain score will be assessed using FLACC scale immediately after transfer to the PACU, at 1, 2, 4, 6, 8, 12 hours postoperatively and before discharge from hospital.
- If the FLACC score was ≥ 4, analgesia in the form of Paracetamol 15 mg/kg IV will be administered as the first rescue analgesia. The time for the first rescue analgesic administration will be recorded. If this analgesia will not be adequate, intravenous pethidine at 1mg/kg will be given as the second rescue analgesia and the total analgesic requirements of paracetamol and pethidine will be recorded.
- FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of five categories including face, legs, activity, cry, and concealability.
- Conditions
- Post-operative Pain
- Being tested
- Bupivacaine, Dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Bupivacaine will be used in an ESP block to provide postoperative analgesia.
DexmedetomidineDrug
Also called Precedex
Dexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Active comparator | Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with bupivacaine only. Receives: Drug: Bupivacaine |
| Bupivacaine + Dexmedetomidine Group | Experimental | Patients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine. Receives: Drug: Bupivacaine; Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Postoperative Analgesia
Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.
Measured: Up to 24 hours after surgery
Secondary outcomes (4)
Postoperative Pain Scores
- Measured using the Face, Legs, Activity, Cry, Consolability (FLACC) scale.
- Score range: 0 (no pain) to 10 (severe pain).
- Higher scores indicate worse pain.
Measured: At 1, 2, 4, 6, 12, and 24 hours after surgery
Total intraoperative analgesics
Total intraoperative fentanyl consumption in micrograms
Measured: During the operation from the induction of anesthesia until the recovery.
Total Postoperative Analgesic Consumption
The total amount (in milligrams) of rescue analgesics administered to the patient within the first 24 hours after surgery.
Measured: Within 24 hours postoperatively
Incidence of Adverse Effects
The occurrence of adverse effects such as sedation, nausea, vomiting, bradycardia, or hypotension within 24 hours after surgery.
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 May 2025
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Aug 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ahmed G Nowar, MBBCH, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023991
- Sponsor's protocol ID
- FMASU MS113/2025
- Status last verified
- Feb 2025
- First submitted
- 22 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be shared once study is completing
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine to Bupivacaine in US- Guided Erector Spinae Plane Block for Post-operative Pain Management in Pediatric Patients Undergoing Lower Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT07023991
- Acronym / sponsor ID
- FMASU MS113/2025
- Conditions
- Post-operative Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 17 Jun 2025 (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.
This study aims to evaluate the effect of adding dexmedetomidine to bupivacaine in erector spinae plane (ESP) blocks on the duration of postoperative analgesia in pediatric patients undergoing lower abdominal surgery. Effective postoperative pain control in children remains a clinical challenge, and regional anesthesia techniques such as the ESP block have shown promise in improving outcomes.
In this randomized, double-blind clinical trial, pediatric patients scheduled for elective lower abdominal surgeries will be assigned to receive either bupivacaine alone or bupivacaine combined with dexmedetomidine as part of an ultrasound-guided ESP block. The primary outcome is the duration of postoperative analgesia, defined as the time from the block until the first request for rescue analgesia. Secondary outcomes include total analgesic consumption and postoperative pain scores
Detailed description
- Preoperative setting:
- A careful history taking will be done from the parents of the child for any medical disorder such as congenital coagulation disorders or therapeutic anticoagulants.
- A complete physical examination of the child will be done, including the central nervous system for signs of mental disturbance, the chest for any deformities or chest infection, the heart for congenital heart disease, and the back for any spinal deformities or infection at the site of injection.
- Routine preoperative investigations will be done to all patients, including laboratory investigations (complete blood picture, liver and kidney function tests, prothrombin time and partial thromboplastin time) and other as needed by the patient condition.
- Written informed consent will be obtained from all participants' parents or legal guardian prior to the study.
- Intraoperative setting:
- All children will be premedicated orally with midazolam (0.05-0.1 mg/kg over 2-3 minutes, maximum 6 mg) 30 minutes prior to surgery. On arrival of the patients to the operative room, routine monitoring with 5-leads electrocardiogram (ECG), non-invasive blood pressure (NIBP) and pulse oximetry will be instituted, then anesthesia will be induced with 8% sevoflurane in 100% oxygen. After an adequate depth of anesthesia is reached, an intravenous access will be placed under aseptic condition, then all patients will receive intravenous (IV) fentanyl (1 µg/kg) and atracurium (0.5 mg/kg), and orotracheal endotracheal intubation will be performed. Anesthesia will be maintained with a mixture of oxygen-air (50% - 50%) and isoflurane
- -1.5%). Muscle relaxation will be sustained during the procedure with incremental doses of IV atracurium (0.1 mg/kg) every 25 minutes. In group A: US guided ESPB will be performed with aseptic precautions using a (6- 19) MHz linear probe in a sterile cover with sterile jelly (GE LOGIQ 5, USA).
- Technique of US guided ESPB block: The block will be performed by a trained anesthetist in regional anesthetic techniques while the patient in lateral position, the ultrasound transducers will be placed in a parasagittal plane 2-3 cm away from the midline at the level of first lumbar vertebra (L1) (The L1 level will be identified by counting upwards from the sacrum). Sliding the transducer medially till identifying the transverse process which appear as flat acoustic shadow and after identification of erector spinae muscle (ESM) and transverse process, a 22-gauge 50 mm echogenic block needle (Sono Plex® PAJUNK®, Germany) will be introduced in cranio-caudal direction with in-plane technique and after confirming the position of the tip of the needle over the transverse process with negative aspiration to blood or air, Bupivacaine 0.25% (with a maximum dose 2 mg/kg) plus Dexmedetomidine (0.5µg/kg), putting into consideration that the total volume to be 0.3 ml/kg on each side, will be injected. The spread of local anesthetic in a plane below the erector spinae muscle will be visualized.
- The skin incision will be made 15 min after the block.
- Baseline values of heart rate (HR) and mean blood pressure (MAP) will be recorded before skin incision and then recorded at 5, 30, 60 minutes after skin incision and at the end of surgery. Also, patients will be monitored for sign of local anesthetic toxicity.
- Any complications related to the block given will be recorded including hematoma, intravascular injection, and allergic reactions.
- If local anesthetic toxicity occurred, cardiovascular and respiratory support and 20% intralipid bolus of 1.5 ml/kg over 2-3 min will be given.
In group B: This group will receive ESPB using Bupivacaine 0.25% (with a maximum dose 2 mg/kg) alone 15 min before skin incision with the same protocol and precautions.
- In both group an increase in heart rate to 20% above the baseline values at any time during the procedure will be defined as insufficient analgesia and fentanyl 0.5 µg/kg will be given and the total amount of intraoperative opioid will be recorded.
- At the end of the surgery Isoflurane will be discontinued and neostigmine 0.05 mg/kg plus atropine 0.02 mg/kg will be administered to reverse the effect of atracurium. After awakening from anesthesia and achieving an appropriate level of consciousness, the patient will be discharged from the operating room to be transferred to the PACU (Post Anesthesia Care Unit), and pain assessment will be done immediate post extubating.
Postoperative setting:
- Postoperative pain score will be assessed using FLACC scale immediately after transfer to the PACU, at 1, 2, 4, 6, 8, 12 hours postoperatively and before discharge from hospital.
- If the FLACC score was ≥ 4, analgesia in the form of Paracetamol 15 mg/kg IV will be administered as the first rescue analgesia. The time for the first rescue analgesic administration will be recorded. If this analgesia will not be adequate, intravenous pethidine at 1mg/kg will be given as the second rescue analgesia and the total analgesic requirements of paracetamol and pethidine will be recorded.
- FLACC is a behavioral pain assessment scale used for nonverbal or preverbal patients who are unable to self-report their level of pain. Pain is assessed through observation of five categories including face, legs, activity, cry, and concealability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Active comparator | Drug: BupivacainePatients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with bupivacaine only. |
| Bupivacaine + Dexmedetomidine Group | Experimental | Drug: Bupivacaine, Drug: DexmedetomidinePatients in this group will receive an ultrasound-guided erector spinae plane (ESP) block with a combination of bupivacaine and dexmedetomidine. |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients aging 1-7 years old of both sexes.
- Patients scheduled for unilateral or bilateral lower abdominal surgeries.
- American Society of Anesthesiologists (ASA) Physical Status Class I, II
Key exclusion criteria (6 listed)
- Parents or legal guardian refusal of participation in the study.
- Contraindication to regional anesthesia (including coagulopathy and local infection).
- History or known allergy to local anesthetics.
- Past history of any complications related to the block. (including hematoma and intravascular injection)
- Spinal anomalies altered mental status, a history of developmental delay.
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 |
|---|---|---|
| BupivacaineAlso: MarcaineBupivacaine will be used in an ESP block to provide postoperative analgesia. | Drug | Bupivacaine + Dexmedetomidine Group, Bupivacaine Group |
| DexmedetomidineAlso: PrecedexDexmedetomidine will be added to bupivacaine in the ESP block to evaluate its effect on duration of postoperative analgesia. | Drug | Bupivacaine + Dexmedetomidine Group |
Primary outcome
Duration of Postoperative Analgesia
Time frame: Up to 24 hours after surgery
Measurement of the time from recovery of anesthesia to the need of first given dose of rescue analgesia.
4 secondary outcomes
Postoperative Pain Scores
Time frame: At 1, 2, 4, 6, 12, and 24 hours after surgery
Total intraoperative analgesics
Time frame: During the operation from the induction of anesthesia until the recovery.
Total Postoperative Analgesic Consumption
Time frame: Within 24 hours postoperatively
Incidence of Adverse Effects
Time frame: Within 24 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: Yes. All data will be shared once study is completing
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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.
Ahmed G Nowar, MBBCH principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine and Dexmedetomidine in people with Post-operative Pain, run by Ain Shams 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 6 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: enrolling by invitation, as of the sponsor's last update on 17 Jun 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Duration of Postoperative Analgesia (time frame: Up to 24 hours after surgery). 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 17 Jun 2025.