DexmedetomidineNCT06331182
Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain
A study testing Ketamine, Dexmedetomidine and Bupivacaine in people with Dexmedetomidine and Ketamine, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dexmedetomidine, Ketamine, External Oblique Intercostal Plane Block
- What is being tested?
- Ketamine, Dexmedetomidine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Mar 2024to 1 Nov 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Scheduled for open thoracotomy.
Who cannot join
- Patients with neurological or intellectual disability.
- Infection at the injection site.
- Opioid addiction.
- Allergic reaction to local anesthetics.
- Coagulation abnormalities.
- Drug abuse.
Show all 11Show fewer
- Pregnancy.
- Severe liver and/or renal failure.
- Uncontrolled hypertension.
- Severe cardiovascular problems.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial
The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.
Read the detailed description
Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.
As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.
- Conditions
- Dexmedetomidine, Ketamine, External Oblique Intercostal Plane Block, Post Thoracotomy Pain
- Being tested
- Ketamine, Dexmedetomidine, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
DexmedetomidineDrug
Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
BupivacaineDrug
29 ml bupivacaine 0.25%
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Experimental | Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia. Receives: Drug: Ketamine; Drug: Bupivacaine |
| Dex group | Experimental | Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia. Receives: Drug: Dexmedetomidine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to the 1st rescue analgesia
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Measured: 48 hours postoperative.
Secondary outcomes (6)
Intraoperative fentanyl consumption
Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: Intraoperative
Total morphine consumption in the 1st 24hr and 48 hr
Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS)> 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
NRS (0 represents "no pain" while 10 represents "the worst pain imaginable")
Measured: 48 hours postoperatively.
Degree of pain
Degree of pain will be assessed by the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Measured: 48 hours postoperatively.
Heart rate
Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery.
Mean arterial blood
Mean arterial blood will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Measured: Till the end of surgery.
The incidence of adverse events
Adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication.
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start26 Mar 2024
- Primary completion1 Nov 2024
- Study completion1 Nov 2024
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 DexmedetomidineStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Said ElSharkawy, Tanta University
- Investigators
- Mohammed S Elsharkawy, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331182
- Sponsor's protocol ID
- 36264PR552/2/24
- Status last verified
- Jan 2025
- First submitted
- 17 Mar 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Moharam SA, ElSharkawy MS, Abdelhamid AS, Abdelbadie A, Kohaf NA, El Rahman Elgaria MA, Attia A, Elkashef AM. Dexmedetomidine versus ketamine as adjuvants in external oblique intercostal plane block for post thoracotomy pain: a randomised trial. BMC Anesthesiol. 2025 Nov 26;25(1):602. doi: 10.1186/s12871-025-03476-2.
PubMed 41299290
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial
- ClinicalTrials.gov ID
- NCT06331182
- Acronym / sponsor ID
- 36264PR552/2/24
- Conditions
- Dexmedetomidine, Ketamine, External Oblique Intercostal Plane Block, Post Thoracotomy Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 1 Nov 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 26 Mar 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.
The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.
Detailed description
Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.
As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Experimental | Drug: Ketamine, Drug: BupivacainePatients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia. |
| Dex group | Experimental | Drug: Dexmedetomidine, Drug: BupivacainePatients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- Both sexes.
- American Society of Anesthesiology (ASA) physical status I-III.
- Scheduled for open thoracotomy.
Key exclusion criteria (11 listed)
- Patients with neurological or intellectual disability.
- Infection at the injection site.
- Opioid addiction.
- Allergic reaction to local anesthetics.
- Coagulation abnormalities.
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 |
|---|---|---|
| KetaminePatients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia. | Drug | Ketamine group |
| DexmedetomidinePatients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia. | Drug | Dex group |
| Bupivacaine29 ml bupivacaine 0.25% | Drug | Dex group, Ketamine group |
Primary outcome
Time to the 1st rescue analgesia
Time frame: 48 hours postoperative.
A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
6 secondary outcomes
Intraoperative fentanyl consumption
Time frame: Intraoperative
Total morphine consumption in the 1st 24hr and 48 hr
Time frame: 48 hours postoperatively.
Degree of pain
Time frame: 48 hours postoperatively.
Heart rate
Time frame: Till the end of surgery.
Mean arterial blood
Time frame: Till the end of surgery.
The incidence of adverse events
Time frame: 48 hours postoperative
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 7 Jan 2025.
- Derived from this study: PubMed 41299290Moharam SA, ElSharkawy MS, Abdelhamid AS, Abdelbadie A, Kohaf NA, El Rahman Elgaria MA, Attia A, Elkashef AM. Dexmedetomidine versus ketamine as adjuvants in external oblique intercostal plane block for post thoracotomy pain: a randomised trial. BMC Anesthesiol. 2025 Nov 26;25(1):602. doi: 10.1186/s12871-025-03476-2.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
Mohammed S Elsharkawy, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine, Dexmedetomidine and Bupivacaine in people with Dexmedetomidine and Ketamine, 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 4 inclusion and 11 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 7 Jan 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.
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?
Time to the 1st rescue analgesia (time frame: 48 hours postoperative.). 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 NCT06331182, 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 7 Jan 2025.