Postoperative Analgesia After Disc SurgeryEarly Phase 1NCT03285282
Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery
A Early Phase 1 study testing Thoracolumber interfascial plane block in people with Postoperative Analgesia After Disc Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Postoperative Analgesia After Disc Surgery
- What is being tested?
- Thoracolumber interfascial plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 8 May 2017to Nov 2017
- Phase
- Early Phase 1
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery
Who cannot join
- Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.
Trial locations and contacts
1 site in 1 country.
Mohamed Taeimah, MD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine
Cairo, 1234
Waleed Abdalla, MD
About this study
Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.
- Being tested
- Thoracolumber interfascial plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracolumber interfascial plane blockProcedure or surgery
Thoracolumber interfascial plane block versus placebo
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Thoracolumber interfascial plane block Receives: Procedure: Thoracolumber interfascial plane block |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Score
Measured: 24 hrs postoperative
Secondary outcomes (1)
Total morphine consumption
Measured: 24 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start8 May 2017
- Primary completionOct 2017 (estimated)
- Study completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Analgesia After Disc SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03285282
- Sponsor's protocol ID
- 123/2017
- Status last verified
- Sep 2017
- First submitted
- 14 Sep 2017
- Last updated
- 18 Sep 2017
- 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 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thoracolumbar Interfascial Plane Block for Postoperative Analgesia After Herniated Lumbar Disc Surgery
- ClinicalTrials.gov ID
- NCT03285282
- Acronym / sponsor ID
- 123/2017
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 8 May 2017 (actual)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 18 Sep 2017 (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.
Several regional anesthesia have been shown to improve postoperative outcomes in many studies. The transversus abdominis plane (TAP) block provides anesthesia to the abdominal wall by introducing local anesthetic to the anterior rami of the spinal nerve roots. This work evaluates the analgesic effects gained after performing thoracolumbar interfacial plane block (analogous to the TAP block but intended for the back) which targets the sensory component of the dorsal rami of the thoracolumbar nerves in patients undergoing back surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Procedure: Thoracolumber interfascial plane blockThoracolumber interfascial plane block |
| Control | No intervention | – |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patients with ASA 1 or 2 aged between 21years old up to 60 years old of both sex scheduled of back surgery
Key exclusion criteria (1 listed)
- Exclusion criteria will be patients refusal or inability to give an informed consent , history of relevant allergy to any of the drugs used in the procedure , previous lumbar spine surgery or back surgery with planed spinal fixation.
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 |
|---|---|---|
| Thoracolumber interfascial plane blockThoracolumber interfascial plane block versus placebo | Procedure or surgery | Intervention |
Primary outcome
Visual Analogue Score
Time frame: 24 hrs postoperative
1 secondary outcome
Total morphine consumption
Time frame: 24 hrs postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Analgesia After Disc Surgery
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Not yet recruitingObservational study
Comparison of TLIP Block and QIP Block for Postoperative Analgesia After Lumbar Spine Surgery
Lumbar Disc Herniation, Postoperative Pain
Recruiting
Quadro-Iliac vs Thoracolumbar Interfascial Plane Block for Analgesia After Single-Level Lumbar Disc Surgery
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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.
Mohamed Taeimah, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thoracolumber interfascial plane block in people with Postoperative Analgesia After Disc Surgery, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mona Ammar, MD (01006236620, Mona_3mmar@Hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Score (time frame: 24 hrs postoperative). 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 Sep 2017.