Regional Anesthesia MorbidityPhase 4LaGRANCT03394807
LaGRA Trial in Laparoscopic Cholecystectomy
A Phase 4 study testing Levobupivacaine in people with Regional Anesthesia Morbidity and Gallbladder Stone, run by Health Service Executive, Ireland.
Trial summary
This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Regional Anesthesia Morbidity, Gallbladder Stone, Pain
- What is being tested?
- Levobupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 30 Aug 2017
- Phase
- Phase 4
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy
- ASA I, II or III
Who cannot join
- Patients that don't consent to be included
- Allergy to levobupivacaine
About this study
Official title: Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.
This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.
Read the detailed description
A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.
Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).
- Conditions
- Regional Anesthesia Morbidity, Gallbladder Stone, Pain
- Being tested
- Levobupivacaine, Placebo
- Medical subject headings
- Cholecystolithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevobupivacaineDrug
Also called Chirocaine
Levobupivacaine injection to Transversus abdominis plane and rectus sheath
PlaceboDrug
Also called Saline
Saline injection to Transversus abdominis plane and rectus sheath
| Study group | Role | What they receive |
|---|---|---|
| LaGRA | Experimental | regional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal Receives: Drug: Levobupivacaine |
| Placebo | Placebo comparator | Sham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain score
Visual analogue pain scores ranging from 0 to 10
Measured: 6 hours post operatively
Secondary outcomes (4)
Opioid use
Amount (mg) of opioid medication administered
Measured: Perioperative period including first 6 hours post operatively
Analgesic use
Type and dose of all non opioid analgesic medications prescribed
Measured: Perioperative period including first 6 hours post operatively
Readmission rate
Patient readmitted to hospital for any reason
Measured: 30 days post operative
Daycase rates
Patient that was planned for daycase but admitted overnight
Measured: Day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start1 Oct 2016
- Primary completion30 Jul 2017
- Study completion30 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, placebo controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Service Executive, Ireland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Des Toomey, Health Service Executive, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394807
- Sponsor's protocol ID
- LaGRA-MRHM
- Acronym
- LaGRA
- Status last verified
- Jan 2018
- First submitted
- 15 Dec 2017
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03394807
- Acronym / sponsor ID
- LaGRA / LaGRA-MRHM
- Conditions
- Regional Anesthesia Morbidity, Gallbladder Stone, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Health Service Executive, IrelandUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Aug 2017 (actual)
- First posted
- 9 Jan 2018 (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.
This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.
Detailed description
A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.
Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomised, placebo controlled trial
| Arm | Type | Receives |
|---|---|---|
| LaGRA | Experimental | Drug: Levobupivacaineregional anaesthesia of the right upper quadrant by injection of levobupivacaine 0.25% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal |
| Placebo | Placebo comparator | Drug: PlaceboSham regional anaesthesia of the right upper quadrant by injection of Saline 0.9% to the transversus abdominis plane and the rectus sheath under laparoscopic guidance immediately following specimen removal |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing laparoscopic cholecystectomy
- ASA I, II or III
Key exclusion criteria (2 listed)
- Patients that don't consent to be included
- Allergy to levobupivacaine
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 |
|---|---|---|
| LevobupivacaineAlso: ChirocaineLevobupivacaine injection to Transversus abdominis plane and rectus sheath | Drug | LaGRA |
| PlaceboAlso: SalineSaline injection to Transversus abdominis plane and rectus sheath | Drug | Placebo |
Primary outcome
Post operative pain score
Time frame: 6 hours post operatively
Visual analogue pain scores ranging from 0 to 10
4 secondary outcomes
Opioid use
Time frame: Perioperative period including first 6 hours post operatively
Analgesic use
Time frame: Perioperative period including first 6 hours post operatively
Readmission rate
Time frame: 30 days post operative
Daycase rates
Time frame: Day of 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 9 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levobupivacaine in people with Regional Anesthesia Morbidity and Gallbladder Stone, run by Health Service Executive, Ireland.
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 2 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 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Post operative pain score (time frame: 6 hours post operatively). 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 9 Jan 2018.