DexmedetomidineNCT05291364
Dexmedetomidine in Splanchnic Nerve Neurolysis
A study testing Group 1 and Group 2 in people with Dexmedetomidine, run by Minia University at 1 site in Egypt.
Trial summary
Malignancy related abdominal and pelvic pain can be debilitating and affects survival as well as quality of life. Pain from cancer and its treatments can result in anxiety, depression, fear, anger, helplessness, and hopelessness, and those with both pain and depression have an amplification of disability and poor… Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Dexmedetomidine
- What is being tested?
- Group 1 and Group 2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2020to 30 Jul 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient diagnosed to have abdominal malignancy aged 25 to 70 years old
- Fully conscious
- Patient has no hematological disease or coagulation abnormality.
- Patient has no history of mental illness
- Patient with persistent and moderate to severe abdominal pain visual analogue scale score > 4.
Who cannot join
- Patient refusal of the procedure
- Extremes of age
- Patients with psychiatric disorders
- Patient diagnosed to have any coagulation defect or bleeding tendency
- Patients with cardiopulmonary significant condition
- Skin infection or wounds at site of proposed needle insertion site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Adding Dexmedetomidine to Alcohol in Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain.
Malignancy related abdominal and pelvic pain can be debilitating and affects survival as well as quality of life. Pain from cancer and its treatments can result in anxiety, depression, fear, anger, helplessness, and hopelessness, and those with both pain and depression have an amplification of disability and poor quality of life Pancreatic and other upper abdominal organ malignancies can produce intense visceral pain syndromes that are frequently treated with splanchnic nerve neurolysis (SNN) or celiac plexus neurolysis (CPN). Dexmedetomidine is a selective alpha two adreno-receptor agonist. It provides dose-dependent sedation, analgesia, sympatholysis, and anxiolysis without relevant respiratory depression. Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. The aim of this study is to evaluate effect of addition of dexmedetomidine as an adjuvant to alcohol and local anesthetics for chemical neurolysis to control pain in patients with intra-abdominal malignancy.
Read the detailed description
Patients fasted for 6 hours prior to the procedure, and a 20 G intravenous cannula was placed. Before the procedure, 500 mL of physiological saline was administered intravenously. The patient was positioned in the prone position on the surgical table with the chest supported using a pillow, to reverse the thoracolumbar lordosis and to increase the distance between the superior iliac spine and the chest cage. The patient was monitored using electrocardiography, non-invasive blood pressure measurements, and pulse oximetry in accordance with the standards proposed by the American Association of Anesthesiologists. On arrival at the operating room, electrocardiogram, pulse oximetry, and non-invasive arterial blood pressure were applied and vital signs were obtained.
Twenty-two Gauge spinal needle introduced at 11th intercostal space 6 cm from midline and advanced to touch the anterolateral aspect of T11. Again, with AP and lateral views the placement of the needles was confirmed using contrast dye under fluoroscopy.
Splanchnic nerve blockade will be performed by using (4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml) administered bilaterally (a total volume of 12 ml) with addition of 2 μg/kg dexmedetomidine patients in group (1).
The procedure lasted 30 minutes, and the recovery period lasted 10 minutes since conscious sedation was used. After the procedure, patients were kept under medical observation for 4 to 6 hours to monitor possible hemodynamic complications.
Parameters assessed:
- Hemodynamic parameters: Heart rate, respiratory rate and oxygen saturation were recorded before and immediately after the blockade and follow up on time intervals over 2 weeks after the blockade.
- Analgesic requirements: First time to require additional analgesics
- Visual Analogue Scale: The Visual Analogue Scale score (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'.The score of pain intensity was determined by patients providing a mark between 0-10 cm with score from 0-4 cm mild pain. 5- 7 cm moderated and 8-10 severe pain
- Incidence of complications: In the form of hemodynamic instability, constitutional symptoms as (nausea, vomiting and diarrhea)
- Conditions
- Dexmedetomidine
- Being tested
- Group 1, Group 2
- Keywords
- Splanchnic Nerve Neurolysis, Chronic cancer Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Drug
Also called dexmedetomidine
Is formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml + 2 μg/kg dexmedetomidine diluted in 0.9% sterile saline (total volume 12 ml) on each side
Group 2Drug
Also called ethanol
Is formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml diluted in 0.9% sterile saline (total volume 12 ml) on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | injection of ethanol and lidocaine with dexmedetomidine Receives: Drug: Group 1 |
| Group 2 | Active comparator | injection of ethanol and lidocaine Without dexmedetomidine Receives: Drug: Group 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Visual Analogue Scale which measure the pain intensity . It determined by patients providing a mark between 0-10 cm with score from 0-4 cm mild pain. 5- 7 cm moderated and 8-10 severe pain. it was recorded prior to injection and after injection by 6,12,24,72 hours and after one and two weeks
Measured: 2 weeks
Secondary outcomes (1)
the time of analgesic requirement
measure the time with hours passes after the injection to require additional analgesics as tramadol
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start30 Sep 2020
- Primary completion30 Jun 2022
- Study completion30 Jul 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 DexmedetomidineStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, haidy salah mansour, Minia University
- Investigators
- Haidy S Mansour, Study director, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291364
- Sponsor's protocol ID
- 673-8/2020
- Status last verified
- Jul 2023
- First submitted
- 3 Mar 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mansour HS, Hassanein Mohmed A, Sayed TI, Abd-Elwahab AT. Dexmedetomidine in Fluoroscopic Guided Splanchnic Nerve Neurolysis for Pain Control: A Randomized, Controlled Trial. Pain Physician. 2024 Jan;27(1):E37-E44.
PubMed 38285029
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Adding Dexmedetomidine to Alcohol in Splanchnic Nerve Neurolysis for the Treatment of Intra-Abdominal Cancer Pain.
- ClinicalTrials.gov ID
- NCT05291364
- Acronym / sponsor ID
- 673-8/2020
- Conditions
- Dexmedetomidine
- Keywords
- Splanchnic Nerve Neurolysis, Chronic cancer Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 22 Mar 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.
Malignancy related abdominal and pelvic pain can be debilitating and affects survival as well as quality of life. Pain from cancer and its treatments can result in anxiety, depression, fear, anger, helplessness, and hopelessness, and those with both pain and depression have an amplification of disability and poor quality of life Pancreatic and other upper abdominal organ malignancies can produce intense visceral pain syndromes that are frequently treated with splanchnic nerve neurolysis (SNN) or celiac plexus neurolysis (CPN). Dexmedetomidine is a selective alpha two adreno-receptor agonist. It provides dose-dependent sedation, analgesia, sympatholysis, and anxiolysis without relevant respiratory depression. Dexmedetomidine is used as adjuvant to LA drugs in peripheral nerve block, brachial plexus block and intrathecal anesthesia with satisfactory results. The aim of this study is to evaluate effect of addition of dexmedetomidine as an adjuvant to alcohol and local anesthetics for chemical neurolysis to control pain in patients with intra-abdominal malignancy.
Detailed description
Patients fasted for 6 hours prior to the procedure, and a 20 G intravenous cannula was placed. Before the procedure, 500 mL of physiological saline was administered intravenously. The patient was positioned in the prone position on the surgical table with the chest supported using a pillow, to reverse the thoracolumbar lordosis and to increase the distance between the superior iliac spine and the chest cage. The patient was monitored using electrocardiography, non-invasive blood pressure measurements, and pulse oximetry in accordance with the standards proposed by the American Association of Anesthesiologists. On arrival at the operating room, electrocardiogram, pulse oximetry, and non-invasive arterial blood pressure were applied and vital signs were obtained.
Twenty-two Gauge spinal needle introduced at 11th intercostal space 6 cm from midline and advanced to touch the anterolateral aspect of T11. Again, with AP and lateral views the placement of the needles was confirmed using contrast dye under fluoroscopy.
Splanchnic nerve blockade will be performed by using (4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml) administered bilaterally (a total volume of 12 ml) with addition of 2 μg/kg dexmedetomidine patients in group (1).
The procedure lasted 30 minutes, and the recovery period lasted 10 minutes since conscious sedation was used. After the procedure, patients were kept under medical observation for 4 to 6 hours to monitor possible hemodynamic complications.
Parameters assessed:
- Hemodynamic parameters: Heart rate, respiratory rate and oxygen saturation were recorded before and immediately after the blockade and follow up on time intervals over 2 weeks after the blockade.
- Analgesic requirements: First time to require additional analgesics
- Visual Analogue Scale: The Visual Analogue Scale score (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'.The score of pain intensity was determined by patients providing a mark between 0-10 cm with score from 0-4 cm mild pain. 5- 7 cm moderated and 8-10 severe pain
- Incidence of complications: In the form of hemodynamic instability, constitutional symptoms as (nausea, vomiting and diarrhea)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Group 1injection of ethanol and lidocaine with dexmedetomidine |
| Group 2 | Active comparator | Drug: Group 2injection of ethanol and lidocaine Without dexmedetomidine |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient diagnosed to have abdominal malignancy aged 25 to 70 years old
- Fully conscious
- Patient has no hematological disease or coagulation abnormality.
- Patient has no history of mental illness
- Patient with persistent and moderate to severe abdominal pain visual analogue scale score > 4.
Key exclusion criteria (6 listed)
- Patient refusal of the procedure
- Extremes of age
- Patients with psychiatric disorders
- Patient diagnosed to have any coagulation defect or bleeding tendency
- Patients with cardiopulmonary significant condition
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 |
|---|---|---|
| Group 1Also: dexmedetomidineIs formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml + 2 μg/kg dexmedetomidine diluted in 0.9% sterile saline (total volume 12 ml) on each side | Drug | Group 1 |
| Group 2Also: ethanolIs formed of 20 patients had splanchnic plexus block with 4.5 ml ethanol 96% + 1.5 ml of lidocaine 10 mg/ml diluted in 0.9% sterile saline (total volume 12 ml) on each side. | Drug | Group 2 |
Primary outcome
Visual Analogue Scale
Time frame: 2 weeks
Visual Analogue Scale which measure the pain intensity . It determined by patients providing a mark between 0-10 cm with score from 0-4 cm mild pain. 5- 7 cm moderated and 8-10 severe pain. it was recorded prior to injection and after injection by 6,12,24,72 hours and after one and two weeks
1 secondary outcome
the time of analgesic requirement
Time frame: 2 weeks
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 1 Aug 2023.
- Derived from this study: PubMed 38285029Mansour HS, Hassanein Mohmed A, Sayed TI, Abd-Elwahab AT. Dexmedetomidine in Fluoroscopic Guided Splanchnic Nerve Neurolysis for Pain Control: A Randomized, Controlled Trial. Pain Physician. 2024 Jan;27(1):E37-E44.
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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.
Haidy S Mansour study director
Associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 and Group 2 in people with Dexmedetomidine, run by Minia 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 5 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: finished, as of the sponsor's last update on 1 Aug 2023. 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?
Visual Analogue Scale (time frame: 2 weeks). 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 NCT05291364, 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 1 Aug 2023.