Major Abdominal SurgeryPhase 2/3triamcinoloneNCT04480775
Triamcinolone Versus Methylprednisolone in Transversus Abdominis Plane Block
A Phase 2/3 study testing Triamcinolone, Methylprednisolone and bupivacaine in people with Major Abdominal Surgery, run by ghada fouad at 1 site in Egypt.
Trial summary
In the current Study we will compare between triamcinolone and methylprednisolone as an additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery . Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Major Abdominal Surgery
- What is being tested?
- Triamcinolone, Methylprednisolone and bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2020to 15 Dec 2020
- Phase
- Phase 2/3
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for major open abdominal surgery
- American Society Anesthesiologists (ASA) physical status I to II
Who cannot join
- Patient refusal.
- Morbidly obese patients.
- Patients with uncontrolled diabetes.
- Severe or uncontrolled renal, hepatic or endocrinal diseases.
- Pregnancy, post-partum or lactating females
- Allergy to one of the agents used.
- Recent (less than six months) use of glucocorticoids for at least two weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery
In the current Study we will compare between triamcinolone and methylprednisolone as an additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .
Read the detailed description
Postoperative pain is one of the main causes of respiratory function derangement after abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal surgery for postoperative analgesia The transversus abdominis plane (TAP) block is aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane between the internaloblique and transversus abdominis muscle layers, with the aim of anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall surgery
. It providesadequate postoperative pain relief following various abdominal surgeries TAP block can reduce pain scores, opioid consumption, and the incidence of opioid-related complications after abdominal surgery.
The duration of the TAP block is limited to theeffect of the administered LAs. Various adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify its effects .
Perineural injection of steroids is reported to influence postoperative analgesia.
As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and release of arachidonic acid, and activating anti-inflammatory transcription factors such as lipocortins
- Conditions
- Major Abdominal Surgery
- Being tested
- Triamcinolone, Methylprednisolone, bupivacaine
- Keywords
- triamicinolone, methylprednisolone, transversus abdominisus plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TriamcinoloneDrug
transversus abdominis plane block with bupivacain and triamicinolone
transversus abdominis plane block with bupivacaine and methylprednisolone
bupivacaineDrug
transversus abdominis plane block with bupivacaine alone
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine group | Experimental | 28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides Receives: Drug: bupivacaine |
| triamicinolone group | Active comparator | 28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block Receives: Drug: Triamcinolone; Drug: bupivacaine |
| methylprednisolone group | Active comparator | 28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block. Receives: Drug: Methylprednisolone; Drug: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).
visual analogue scale for assessement of pain from 0 to 10 is used where 0 is no pain and 10 is maximum pain
Measured: 24 hours after surgery
Secondary outcomes (1)
occurance of complication
nausea vomiting hemodynamic changes
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start15 Jul 2020
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Abdominal SurgeryStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patient will be evaluated pre operative and full lab will be done In the Pre Anaesthesia Room ,a 20 gauge venous catheter will be inserted in the upper limb , and monitoring included heart rate, electrocardiogram, noninvasiveblood pressure, and peripheral oxygen saturation.Oxygen at the rate of 6 L/min will beadministered through oxygen mask to all patients. The anesthesiologist who performed the block will be blinded to drug solution and not involved in data collection, another anesthesiologist will prepare drug solution and other anesthesiologist collect the data.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- ghada fouad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ghada fouad, Mansoura University
- Investigators
- marwa M elegemazy, master, Principal investigator, Mansoura Universityghada f amer, M.D, Study director, associate professor of anesthesiaEiad a ramzy, M.D, Study chair, associate professor of anesthesiaabdelaziz a motaweaa, M.D, Study chair, professor of anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480775
- Sponsor's protocol ID
- (MS.20.01.999-2020/01/10)
- Acronym
- triamcinolone
- Status last verified
- Mar 2021
- First submitted
- 13 Jul 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triamcinolone Versus Methylprednisolone in Ultrasound Guided Transversus Abdominis Plane Block in Major Open Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04480775
- Acronym / sponsor ID
- triamcinolone / (MS.20.01.999-2020/01/10)
- Conditions
- Major Abdominal Surgery
- Keywords
- triamicinolone, methylprednisolone, transversus abdominisus plane block
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- ghada fouadUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 21 Jul 2020 (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.
In the current Study we will compare between triamcinolone and methylprednisolone as an additive to bupivacaine drug in ultrasound guided TAP block in major open abdominal surgery .
Detailed description
Postoperative pain is one of the main causes of respiratory function derangement after abdominal surgery .Transversus abdominis plane (TAP) block is widely used in abdominal surgery for postoperative analgesia The transversus abdominis plane (TAP) block is aperipheral nerve block that involves the injection of alocal anesthetic (LA) in the plane between the internaloblique and transversus abdominis muscle layers, with the aim of anesthetizing the intercostal nerves supplyingthe abdominal wall (from T6 to L1) By blocking intercostal nerves T6 to L1, TAPblock efficiently blocks somatic pain after abdominalwall surgery
. It providesadequate postoperative pain relief following various abdominal surgeries TAP block can reduce pain scores, opioid consumption, and the incidence of opioid-related complications after abdominal surgery.
The duration of the TAP block is limited to theeffect of the administered LAs. Various adjuvantmedications have been added to the LA to prolong theduration of TAP block and magnify its effects .
Perineural injection of steroids is reported to influence postoperative analgesia.
As a synthetic glucocorticoid, triamcinolone acetonide binds to and activates the glucocorticoid receptor to produce anti-inflammatory responses,such as down-regulating pro-inflammatory cytokine expression , preventing prostaglandin and leukotriene synthesis and release of arachidonic acid, and activating anti-inflammatory transcription factors such as lipocortins
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Patient will be evaluated pre operative and full lab will be done In the Pre Anaesthesia Room ,a 20 gauge venous catheter will be inserted in the upper limb , and monitoring included heart rate, electrocardiogram, noninvasiveblood pressure, and peripheral oxygen saturation.Oxygen at the rate of 6 L/min will beadministered through oxygen mask to all patients. The anesthesiologist who performed the block will be blinded to drug solution and not involved in data collection, another anesthesiologist will prepare drug solution and other anesthesiologist collect the data.
| Arm | Type | Receives |
|---|---|---|
| bupivacaine group | Experimental | Drug: bupivacaine28 Patients will receive 18 ml of bupivacaine 0.5 % plus 1ml 0.9% saline in TAP block divided equally on both sides |
| triamicinolone group | Active comparator | Drug: Triamcinolone, Drug: bupivacaine28 Patient will receive 18 ml of bupivacaine 0.5 % plus (20 mg of triamcinolone in 1ml 0.9% saline divided equally on both sides in TAP block |
| methylprednisolone group | Active comparator | Drug: Methylprednisolone, Drug: bupivacaine28 Patient will receive 18 ml of bupivacaine 0.5 % plus (40 mg of methylprednisolone in 1ml 0.9% saline ) on both sides in TAP block. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients scheduled for major open abdominal surgery
- American Society Anesthesiologists (ASA) physical status I to II
Key exclusion criteria (7 listed)
- Patient refusal.
- Morbidly obese patients.
- Patients with uncontrolled diabetes.
- Severe or uncontrolled renal, hepatic or endocrinal diseases.
- Pregnancy, post-partum or lactating females
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 |
|---|---|---|
| Triamcinolonetransversus abdominis plane block with bupivacain and triamicinolone | Drug | triamicinolone group |
| Methylprednisolonetransversus abdominis plane block with bupivacaine and methylprednisolone | Drug | methylprednisolone group |
| bupivacainetransversus abdominis plane block with bupivacaine alone | Drug | bupivacaine group, methylprednisolone group, triamicinolone group |
Primary outcome
analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ).
Time frame: 24 hours after surgery
visual analogue scale for assessement of pain from 0 to 10 is used where 0 is no pain and 10 is maximum pain
1 secondary outcome
occurance of complication
Time frame: 24 hours after surgery
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 3 Mar 2021.
- Individual participant dataSharing planned: No
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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.
marwa M elegemazy, master principal investigator
Mansoura University
ghada f amer, M.D study director
associate professor of anesthesia
Eiad a ramzy, M.D study chair
associate professor of anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Triamcinolone, Methylprednisolone and bupivacaine in people with Major Abdominal Surgery, run by ghada fouad 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 2 inclusion and 7 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 3 Mar 2021. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
analgesic effect of Triamcinolone and Methylprednisolone In Ultrasound Guided Transversus Abdominis Plane Block ( Tap Block ). (time frame: 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 3 Mar 2021.