Gall StonesNCT01090882
Intraperitoneal Techniques of Local Anaesthesia During Laparoscopic Cholecystectomy
A study testing Bupivocaine and 0.9% normal saline solution in people with Gall Stones, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gall Stones
- What is being tested?
- Bupivocaine and 0.9% normal saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2009to Oct 2009
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective laparoscopic cholecystectomy
- 18 years old or over
Who cannot join
- Emergency surgery
- Under 18 year olds
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.
Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.
- Conditions
- Gall Stones
- Being tested
- Bupivocaine, 0.9% normal saline solution
- Keywords
- Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery
- Medical subject headings
- Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivocaineDrug
Also called marcaine
20ml 0.25% at beginning of operation
0.9% normal saline solutionDrug
Also called marcaine
20ml 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Sham wash, sham injection Receives: Drug: 0.9% normal saline solution |
| Subperitoneal injection | Experimental | Local anaesthetic injection to diaphragm with sham wash over liver and gall bladder Receives: Drug: Bupivocaine |
| Topical LA | Active comparator | Local anaesthetic washed over gall bladder and liver. Sham injection of diaphragm Receives: Drug: Bupivocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS pain score
Measured: 1, 4, 8 hours after operation and at discharge
Secondary outcomes (3)
Time to ambulation
The first time the patient gets out of bed and walks following the procedure
Measured: following the procedure
Same day discharge
Measured: 24 hours
VRS pain scores
Immediately following the operation
Measured: Every 10 minutes in theatre recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startJul 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gall StonesStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Keith J Roberts, MRCS, Principal investigator, University Hospital Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090882
- Sponsor's protocol ID
- UHCW 1
- Status last verified
- Jun 2024
- First submitted
- 18 Mar 2010
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.
PubMed 21638181
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01090882
- Acronym / sponsor ID
- UHCW 1
- Conditions
- Gall Stones
- Keywords
- Local anaesthetic, Laparoscopic cholecystectomy, Pain scores, Bupivocaine, Day case surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Mar 2010 (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.
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash.
Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Drug: 0.9% normal saline solutionSham wash, sham injection |
| Subperitoneal injection | Experimental | Drug: BupivocaineLocal anaesthetic injection to diaphragm with sham wash over liver and gall bladder |
| Topical LA | Active comparator | Drug: BupivocaineLocal anaesthetic washed over gall bladder and liver. Sham injection of diaphragm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective laparoscopic cholecystectomy
- 18 years old or over
Key exclusion criteria (2 listed)
- Emergency surgery
- Under 18 year olds
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 |
|---|---|---|
| BupivocaineAlso: marcaine20ml 0.25% at beginning of operation | Drug | Subperitoneal injection, Topical LA |
| 0.9% normal saline solutionAlso: marcaine20ml 0.9% NaCl | Drug | Control |
Primary outcome
VAS pain score
Time frame: 1, 4, 8 hours after operation and at discharge
3 secondary outcomes
Time to ambulation
Time frame: following the procedure
Same day discharge
Time frame: 24 hours
VRS pain scores
Time frame: Every 10 minutes in theatre recovery
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 20 Jun 2024.
- Derived from this study: PubMed 21638181Roberts KJ, Gilmour J, Pande R, Nightingale P, Tan LC, Khan S. Efficacy of intraperitoneal local anaesthetic techniques during laparoscopic cholecystectomy. Surg Endosc. 2011 Nov;25(11):3698-705. doi: 10.1007/s00464-011-1757-3. Epub 2011 Jun 3.
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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.
Keith J Roberts, MRCS principal investigator
University Hospital Coventry and Warwickshire NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivocaine and 0.9% normal saline solution in people with Gall Stones, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
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 20 Jun 2024. 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 United Kingdom. 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.
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?
VAS pain score (time frame: 1, 4, 8 hours after operation and at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090882, which also lists 1 linked publication.
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 20 Jun 2024.