Post Operative PainPhase 4NCT05552391
Dexametomedine Versus Ketamine as an Adjuvant in Erector Spinae Block for Perioperative Thoracotomy Pain Control
A Phase 4 study testing Bupivacaine, Ketamine Hydrochloride and Dexmedetomidine Hydrochloride in people with Post Operative Pain, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
A double-blind randomized control study to compare the efficacy of dexmedetomidine versus ketamine as an adjuvant in combination with bupivacaine ultrasound-guided ESP block in patients scheduled for cardiothoracic surgeries with thoracotomy incision. Read more about this study
- Who is it for?
- Ages 3 to 36 months
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine, Ketamine Hydrochloride and Dexmedetomidine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 15 Apr 2023
- Phase
- Phase 4
- 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 3 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 3 to 36 months
- weight >5 kg.
- gender both males and females
- cardiothoracic surgeries with thoracotomy incision.
Who cannot join
- 1 Skin erosions , hematomas or infection at or near the injection site.
- 2. coagulopathy,
- 3. History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexametomedine Versus Ketamine as an Adjuvant in Ultrasound Guided Erector Spinae Block for Perioperative Thoracotomy Pain Control in Pediatrics Cardiothoracic Surgeries: A Randomized Controlled Trial
A double-blind randomized control study to compare the efficacy of dexmedetomidine versus ketamine as an adjuvant in combination with bupivacaine ultrasound-guided ESP block in patients scheduled for cardiothoracic surgeries with thoracotomy incision.
Read the detailed description
Following approval from research and ethics committee ,preoperative preparation, and induction of anesthesia Patients will be allocated to three groups according to the type of drug injected.
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Unilateral Ultrasound-guided erector spinae block will be applied in both groups after the induction of anaesthesia. All patients will be tilted onto their left side (lateral position). while the ultrasound-guide unilateral erector spinae block will be performed under completely aseptic conditions. The anatomy will be examined by ultrasonography at 5-6Hz with a35 mm linear probe and a SonoSite M-turbo system (Fujifilm SonoSite, Inc., USA). a 22 g bevel needle will be advanced in a cephalad to caudad direction until the tip of the needle reach' the plane deep to the erector spinae muscle and immediately lateral to the transverse process. Once confirmed, after careful aspiration to demonstrate the absence of air or blood. An injection in this plane permitted the block to impact both the dorsal and ventral rami as they exited from the thoracic spine to innervate the chest wall. the block permits a diminished sensation spanning the T3-T10 dermatome levels. confirming the correct tissue plane by hydro-dissection.
Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.
After completion of the surgery, inhalational anesthetics will be stopped as well the muscle relaxant. The patient will be then transferred to the ICU.
Postoperative assessment and analgesic regimen:
Post-operative pain intensity will be assessed using the objective pain score (OPS) by a person who will be blinded to the treatment. OPS score will be recorded at baseline,3,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. for the score 4 or more, which was considered the end point of the study, and at this point. Patients will receiv paracetamol 15 gm / Kg IV /6 h, as components of multimodal analgesia regimen for postoperative pain control.
Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.1mg/kg to maintain resting (OPS) score ˂ 4.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine, Ketamine Hydrochloride, Dexmedetomidine Hydrochloride
- 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
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Ketamine HydrochlorideDrug
Also called Ketalar
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Dexmedetomidine HydrochlorideDrug
Also called Precedex
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Placebo comparator | Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml). Receives: Drug: Bupivacaine |
| bupivacaine - ketamine | Active comparator | Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml). Receives: Drug: Bupivacaine; Drug: Ketamine Hydrochloride |
| bupivacaine - Dexametomedine | Active comparator | Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml). Receives: Drug: Bupivacaine; Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
the duration of analgesia
the duration of analgesia from block start time (time of LA injection) to block end time at which OPS score 4 or more) was recorded.
Measured: immediately at the end of pediatric cardiac operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start1 Sep 2022
- Primary completion1 Mar 2023
- Study completion15 Apr 2023
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Mohamed Elhaddad, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552391
- Sponsor's protocol ID
- N-88-2022
- Status last verified
- Apr 2024
- First submitted
- 20 Sep 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexametomedine Versus Ketamine as an Adjuvant in Ultrasound Guided Erector Spinae Block for Perioperative Thoracotomy Pain Control in Pediatrics Cardiothoracic Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05552391
- Acronym / sponsor ID
- N-88-2022
- Conditions
- Post Operative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 Apr 2023 (actual)
- First posted
- 23 Sep 2022 (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.
A double-blind randomized control study to compare the efficacy of dexmedetomidine versus ketamine as an adjuvant in combination with bupivacaine ultrasound-guided ESP block in patients scheduled for cardiothoracic surgeries with thoracotomy incision.
Detailed description
Following approval from research and ethics committee ,preoperative preparation, and induction of anesthesia Patients will be allocated to three groups according to the type of drug injected.
Group bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml).
Group bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml).
Group bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml).
Unilateral Ultrasound-guided erector spinae block will be applied in both groups after the induction of anaesthesia. All patients will be tilted onto their left side (lateral position). while the ultrasound-guide unilateral erector spinae block will be performed under completely aseptic conditions. The anatomy will be examined by ultrasonography at 5-6Hz with a35 mm linear probe and a SonoSite M-turbo system (Fujifilm SonoSite, Inc., USA). a 22 g bevel needle will be advanced in a cephalad to caudad direction until the tip of the needle reach' the plane deep to the erector spinae muscle and immediately lateral to the transverse process. Once confirmed, after careful aspiration to demonstrate the absence of air or blood. An injection in this plane permitted the block to impact both the dorsal and ventral rami as they exited from the thoracic spine to innervate the chest wall. the block permits a diminished sensation spanning the T3-T10 dermatome levels. confirming the correct tissue plane by hydro-dissection.
Heart rate, mean arterial pressure, and oxygen saturation will be monitored continuously.
After completion of the surgery, inhalational anesthetics will be stopped as well the muscle relaxant. The patient will be then transferred to the ICU.
Postoperative assessment and analgesic regimen:
Post-operative pain intensity will be assessed using the objective pain score (OPS) by a person who will be blinded to the treatment. OPS score will be recorded at baseline,3,6,12,24 and 48 hours post-operatively to evaluate acute pain will be observed and recorded. for the score 4 or more, which was considered the end point of the study, and at this point. Patients will receiv paracetamol 15 gm / Kg IV /6 h, as components of multimodal analgesia regimen for postoperative pain control.
Persistent or breakthrough pain will be managed with incremental intravenous morphine at a dose of 0.1mg/kg to maintain resting (OPS) score ˂ 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Placebo comparator | Drug: BupivacaineGroup bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml). |
| bupivacaine - ketamine | Active comparator | Drug: Bupivacaine, Drug: Ketamine HydrochlorideGroup bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml). |
| bupivacaine - Dexametomedine | Active comparator | Drug: Bupivacaine, Drug: Dexmedetomidine HydrochlorideGroup bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml). |
Who may qualify
- Ages
- 3 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- age from 3 to 36 months
- weight >5 kg.
- gender both males and females
- cardiothoracic surgeries with thoracotomy incision.
Key exclusion criteria (3 listed)
- 1 Skin erosions , hematomas or infection at or near the injection site.
- 2. coagulopathy,
- 3. History of hypersensitivity to bupivacaine ,ketamine or dexametomedine.
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: MarcaineGroup bupivacaine(Control) (B) received 0.5 ml/kg bupivacaine 0.25% diluted with isotonic saline (total volume15 ml). | Drug | bupivacaine, bupivacaine - Dexametomedine, bupivacaine - ketamine |
| Ketamine HydrochlorideAlso: KetalarGroup bupivacaine - ketamine (K) received 0.5 ml/kg bupivacaine 0.25% with ketamine 2 mg/kg, diluted with isotonic saline (total volume15 ml). | Drug | bupivacaine - ketamine |
| Dexmedetomidine HydrochlorideAlso: PrecedexGroup bupivacaine - Dexametomedine (D) received 0.5 mL/kg bupivacaine 0.25% with dexmedetomidine 1 µg/kg. diluted with isotonic saline (total volume 15ml). | Drug | bupivacaine - Dexametomedine |
Primary outcome
the duration of analgesia
Time frame: immediately at the end of pediatric cardiac operation
the duration of analgesia from block start time (time of LA injection) to block end time at which OPS score 4 or more) was recorded.
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 18 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine, Ketamine Hydrochloride and Dexmedetomidine Hydrochloride in people with Post Operative Pain, run by Kasr El Aini Hospital 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 4 inclusion and 3 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 18 Apr 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the duration of analgesia (time frame: immediately at the end of pediatric cardiac operation). 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 18 Apr 2024.