Postoperative PainPhase 3NCT02783144
Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia
A Phase 3 study testing TAP Block and Dexamethasone, TAP Block and saline and TAP Block and Dexamethasone i.v. in people with Postoperative Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
Trial summary
Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TAP Block and Dexamethasone, TAP Block and saline and TAP Block and Dexamethasone i.v.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 28 Jun 2017to 15 Apr 2019
- Phase
- Phase 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA score I and II
- age 18 years
Who cannot join
- Allergy to local anesthetics
- Allergy to general anesthetics
- Allergy or intolerance to acetaminophen
- Severe renal impairment
- Severe hepatic impairment
- Congestive heart failure
Show all 17Show fewer
- Coagulation disorders
- hypoprotidemia
- Diabetes mellitus History
- Age greater than 70 years
- Age below 18 years
- ASA Physical than 3 Status
- Lack of informed consent
- Patients unable to discernment
- Intolerance to opiates
- Peptic Ulcer
- Abuse of alcohol and / or drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy
Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.
Read the detailed description
In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.
- Conditions
- Postoperative Pain
- Being tested
- TAP Block and Dexamethasone, TAP Block and saline, TAP Block and Dexamethasone i.v.
- Keywords
- Analgesia, Dexamethasone, Levobupivacaine, Ultrasound-guided, Tranversus Abdominis
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP Block and DexamethasoneProcedure or surgery
Also called TAP-Block under ultrasound guidance and dexamethasone
After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine
TAP Block and salineOther
Also called TAP-Block under ultrasound guidance and saline
After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine
TAP Block and Dexamethasone i.v.Drug
Also called TAP-Block under ultrasound guidance and i.v. dexamethasone
After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously
| Study group | Role | What they receive |
|---|---|---|
| TAP Block and Dexamethasone | Experimental | After general anesthesia and before the beginning of surgery, 4 mg of Dexamethasone are added to 20 ml of 0,375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. Receives: Procedure: TAP Block and Dexamethasone |
| TAP Block and Saline | Placebo comparator | After general anesthesia and before the beginning of surgery, 2 ml of saline are added to 20 ml of 0.375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. Receives: Other: TAP Block and saline |
| TAP Block and Dexamethasone i.v. | Active comparator | After general anesthesia and before the beginning of surgery, 20 ml of 0,375% Levobupivacaine are used in Ultrasound-guided Tranversus Abdominis Plain Block. In this group 4 mg of dexamethasone are injected intravenously. Receives: Drug: TAP Block and Dexamethasone i.v. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Extension of analgesia, assessed in minutes after TAP block
After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge.
Measured: 24 hours after surgery
Secondary outcomes (2)
Rest pain, assessed with Visual Analog Scale
Rest pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).
Measured: 24 hours after surgery
Incident pain, assessed with Visual Analog Scale
Incident pain was assessed using Visual Analog Scale (10 steps scale, from 0 as no pain to 10 as the worst imaginable pain).
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 posted26 May 2016 (estimated)
- Study start28 Jun 2017
- Primary completion13 Mar 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Salvatore Hospital of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emiliano Petrucci, San Salvatore Hospital of L'Aquila
- Investigators
- Emiliano Petrucci, Principal investigator, San Salvatore Academic Hospital of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783144
- Sponsor's protocol ID
- 0024575/16
- Status last verified
- Apr 2019
- First submitted
- 11 May 2016
- Last updated
- 18 Apr 2019
- 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 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02783144
- Acronym / sponsor ID
- 0024575/16
- Conditions
- Postoperative Pain
- Keywords
- Analgesia, Dexamethasone, Levobupivacaine, Ultrasound-guided, Tranversus Abdominis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- San Salvatore Hospital of L'AquilaUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 26 May 2016 (estimated)
- 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.
Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.
Detailed description
In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP Block and Dexamethasone | Experimental | Procedure: TAP Block and DexamethasoneAfter general anesthesia and before the beginning of surgery, 4 mg of Dexamethasone are added to 20 ml of 0,375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. |
| TAP Block and Saline | Placebo comparator | Other: TAP Block and salineAfter general anesthesia and before the beginning of surgery, 2 ml of saline are added to 20 ml of 0.375% Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block. |
| TAP Block and Dexamethasone i.v. | Active comparator | Drug: TAP Block and Dexamethasone i.v.After general anesthesia and before the beginning of surgery, 20 ml of 0,375% Levobupivacaine are used in Ultrasound-guided Tranversus Abdominis Plain Block. In this group 4 mg of dexamethasone are injected intravenously. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with ASA score I and II
- age 18 years
Key exclusion criteria (17 listed)
- Allergy to local anesthetics
- Allergy to general anesthetics
- Allergy or intolerance to acetaminophen
- Severe renal impairment
- Severe hepatic impairment
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 |
|---|---|---|
| TAP Block and DexamethasoneAlso: TAP-Block under ultrasound guidance and dexamethasoneAfter general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine | Procedure or surgery | TAP Block and Dexamethasone |
| TAP Block and salineAlso: TAP-Block under ultrasound guidance and salineAfter general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine | Other | TAP Block and Saline |
| TAP Block and Dexamethasone i.v.Also: TAP-Block under ultrasound guidance and i.v. dexamethasoneAfter general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously | Drug | TAP Block and Dexamethasone i.v. |
Primary outcome
Extension of analgesia, assessed in minutes after TAP block
Time frame: 24 hours after surgery
After surgery, the extension of analgesia is evaluated in minutes after TAP Block, in the first 24 hours, from operating theatre discharge.
2 secondary outcomes
Rest pain, assessed with Visual Analog Scale
Time frame: 24 hours after surgery
Incident pain, assessed with Visual Analog Scale
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 18 Apr 2019.
- 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.
Emiliano Petrucci principal investigator
San Salvatore Academic Hospital of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TAP Block and Dexamethasone, TAP Block and saline and TAP Block and Dexamethasone i.v. in people with Postoperative Pain, run by San Salvatore Hospital of L'Aquila at 1 site in Italy.
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 17 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 18 Apr 2019. 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 Italy. 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. Some participants in this study may receive a placebo. 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?
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?
Extension of analgesia, assessed in minutes after 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 18 Apr 2019.