Postoperative AnalgesiaPhase 2/3NCT03863977
Post-operative Analgesic Effects of Dexamethasone Added to Bupivacaine in Transversusabdominis Plane (TAP) Block
A Phase 2/3 study testing Dexamethasone and Bupivacaine in people with Postoperative Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Dexamethasone and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2019to 1 Jan 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Patients' age from 18 to 60 years old,
- physical status ASA I-II (by the American Society of Anesthesiologists),
- Elective unilateral open inguinal hernia repair,
- Under spinal anesthesia
Who cannot join
- age < 18 or > 60,
- American society of anesthesiologist (ASA)class III-IV,
- known allergy to amino amide local anesthetics,
- skin infection and diseases at site of injection.
- coagulation disorders,
- patients with body mass index (BMI) > 35 kg/m2,
- scrotal hernias,
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut university hospitals
Asyut, Assiut Governorate, Egypt, 715715
About this study
Official title: Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair
To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.
Read the detailed description
The transverses abdominis plane block (TAP block) is a regional anesthesia technique that provides analgesia following abdominal surgery . The TAP block significantly reduces pain after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia technique or as a complement to general anesthesia, spinal or local anesthesia .
The investigators designed this study to compare the postoperative analgesic effect of two doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.
- Conditions
- Postoperative Analgesia
- Being tested
- Dexamethasone, Bupivacaine
- Keywords
- TAP block, inguinal hernia
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called dexamethasone acetate
After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.
BupivacaineDrug
Also called plain marcaine
After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
| Study group | Role | What they receive |
|---|---|---|
| Dex4 group | Active comparator | After the surgery, the patients in this group will receive 4 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block. Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| Dex8 group | Active comparator | After the surgery, the patients in this group will receive 8 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block. Receives: Drug: Dexamethasone; Drug: Bupivacaine |
| control group | Active comparator | After the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of the first analgesic request
time of the first analgesic request in the first postoperative 24 hours ,patients will receive analgesia if visual analog scale (VAS) score more than 3
Measured: in the first postoperative 24 hours
Secondary outcomes (1)
change in visual analog scale (VAS)
measuring the change in visual analog scale VAS (0: no pain to 10: worst imaginable pain), to evaluate postoperative analgesia
Measured: 2nd, 4th, 8th, 16th, and 24th postoperative hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start15 Mar 2019
- Primary completion1 Dec 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amani Hassan Abdel-Wahab, Assiut University
- Investigators
- Amany Hassan, Lectural, Principal investigator, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863977
- Sponsor's protocol ID
- IRB:17100670
- Status last verified
- Apr 2020
- First submitted
- 3 Mar 2019
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT03863977
- Acronym / sponsor ID
- IRB:17100670
- Conditions
- Postoperative Analgesia
- Keywords
- TAP block, inguinal hernia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 5 Mar 2019 (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.
To compare the postoperative analgesic effect of two doses of dexamethasone added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.
Detailed description
The transverses abdominis plane block (TAP block) is a regional anesthesia technique that provides analgesia following abdominal surgery . The TAP block significantly reduces pain after open inguinal hernia repair, regardless of whether it is used as a primary anesthesia technique or as a complement to general anesthesia, spinal or local anesthesia .
The investigators designed this study to compare the postoperative analgesic effect of two doses of dexamethasone( 4 mg and 8 mg ) added to bupivacaine in ultrasound-guided TAP block for inguinal hernia repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 60 patients will be divided into two groups according to the dose of dexamethasone added to bupivacaine in the TAP block, I - group ( Group D4 ) 4mg of dexamethasone will be added II - group ( Group D8 ) 8mg of dexamethasone will be added. III-group(control) bupivacaine alone
| Arm | Type | Receives |
|---|---|---|
| Dex4 group | Active comparator | Drug: Dexamethasone, Drug: BupivacaineAfter the surgery, the patients in this group will receive 4 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block. |
| Dex8 group | Active comparator | Drug: Dexamethasone, Drug: BupivacaineAfter the surgery, the patients in this group will receive 8 mg dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block. |
| control group | Active comparator | Drug: BupivacaineAfter the surgery, the patients in this group will 1mg/kg of 0.5% bupivacaine in the TAP block. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients' age from 18 to 60 years old,
- physical status ASA I-II (by the American Society of Anesthesiologists),
- Elective unilateral open inguinal hernia repair,
- Under spinal anesthesia
Key exclusion criteria (7 listed)
- age < 18 or > 60,
- American society of anesthesiologist (ASA)class III-IV,
- known allergy to amino amide local anesthetics,
- skin infection and diseases at site of injection.
- coagulation disorders,
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 |
|---|---|---|
| DexamethasoneAlso: dexamethasone acetateAfter the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block. | Drug | Dex4 group, Dex8 group |
| BupivacaineAlso: plain marcaineAfter the surgery,1mg/kg of 0.5% bupivacaine in the TAP block. | Drug | Dex4 group, Dex8 group, control group |
Primary outcome
time of the first analgesic request
Time frame: in the first postoperative 24 hours
time of the first analgesic request in the first postoperative 24 hours ,patients will receive analgesia if visual analog scale (VAS) score more than 3
1 secondary outcome
change in visual analog scale (VAS)
Time frame: 2nd, 4th, 8th, 16th, and 24th postoperative hours.
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 28 Apr 2020.
Related trials for Postoperative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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.
Amany Hassan, Lectural principal investigator
Assiut university, Egypt
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 Dexamethasone and Bupivacaine in people with Postoperative Analgesia, run by Assiut 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 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 28 Apr 2020. 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?
time of the first analgesic request (time frame: in the first postoperative 24 hours). 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 28 Apr 2020.