Pain, PostoperativePhase 3NCT00180687
Clinical Trial of the Use of Intraperitoneal Local Anaesthetic
A Phase 3 study testing Nebulised Bupivacaine intraperitoneally, Normal Saline and Injected Bupivacaine intraperitoneally in people with Pain, Postoperative, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Nebulised Bupivacaine intraperitoneally, Normal Saline and Injected Bupivacaine intraperitoneally
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2004to Sep 2005
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All they patients undergoing laparoscopic cholecystectomy will be included.
Who cannot join
- Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic
Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.
Read the detailed description
Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required.
This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group:
- Control group
- Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
- Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded.
No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients.
Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas.
The local anaesthetic (approximately 10mls) will be delivered via a fine sterile catheter that will be inserted via the epigastric port under direct vision at the end of the procedure. Afterward the pneumoperitoneum will be deflated and the wound will be closed and subcutaneous local anaesthetic will be injected in and around the wounds.
Postoperatively, all the patients will have PCA as the main analgesia supported by NSAIDs unless contraindicated. Patients will eat and drink as desired and drips will be taken as soon as it is safe to do so.
Postoperative pain scoring will be stared in recovery and continue on the wards using the visual analogue scale.
- Conditions
- Pain, Postoperative
- Being tested
- Nebulised Bupivacaine intraperitoneally, Normal Saline, Injected Bupivacaine intraperitoneally, No Intraperitoneal Therapeutics
- Keywords
- Pain, Nebulisation, Cholecystectomy, Laparoscopic, Bupivacaine, Local Anaesthetic
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebulised Bupivacaine intraperitoneallyDrug
Also called Marcaine
Nebulised Marcaine (Bupivacaine)
Normal SalineDrug
Also called 0.9 % Normal Saline
Nebulised Normal Saline
Injected Bupivacaine intraperitoneallyDrug
Also called Marcaine
Injected Marcaine directly into the peritoneal cavity
No Intraperitoneal TherapeuticsOther
No Intraperitoneal Therapeutics given
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | No intraperitoneal therapeutics (No nebulised Bupivacaine) Receives: Other: No Intraperitoneal Therapeutics |
| IP Aerosolized Normal Saline | Placebo comparator | Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Receives: Drug: Normal Saline |
| Nebulised Bupivacaine intraperitoneally | Experimental | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Receives: Drug: Nebulised Bupivacaine intraperitoneally |
| Injected Bupivacaine intraperitoneally | Active comparator | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Receives: Drug: Injected Bupivacaine intraperitoneally |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Postoperative Pain
Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.
Measured: 0 hours, 6 hours, 12 hours, 24 hours
Secondary outcomes (3)
Number of Vomiting / Nausea Episodes
Nausea and vomiting are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure the number of episodes when the patient suffers from these side effect and correlate them with opioids use.
Measured: 24 hours
Hours Needed for Safe Mobilization
Drowsiness and delayed mobilization are known adverse effect of opioids usage. By reducing the use of opioids we can reduce or abolish these side effect which will enhance early patient recovery and discharge and reduce hospital cost. We will measure how many hours will take the patient to mobilize freely and safely and correlate them with opioids use.
Measured: 24 Hours
Postoperative Morphine Use
The reduction in cost comes from reducing the use of opioid which requires nursing supervision and also special pump to be delivered as in the cases of patient controlled analgesia. With that reduction, there will be a reduction in opioid related adverse events that mandate medical or nursing attention and prolong hospitalization, these adverse events include nausea and vomiting, delay mobilization due to drowsiness and alter mental status caused by opioid usage. For these reasons we are collecting data related to these adverse events
Measured: 24 Hoiurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionSep 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nawar Alkhamesi, Imperial College London
- Investigators
- Nawar A Alkhamesi, MD, PhD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180687
- Sponsor's protocol ID
- 02.CD/218E
- Other IDs
- Dr. David Peck, Prof. Sir Ara Darzi
- Status last verified
- Aug 2015
- First submitted
- 12 Sep 2005
- Last updated
- 15 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
PubMed 17180268
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Double Blind Randomized Controlled Trial of the Use of Intraperitoneal Nebulised Local Anaesthetic
- ClinicalTrials.gov ID
- NCT00180687
- Acronym / sponsor ID
- 02.CD/218E
- Conditions
- Pain, Postoperative
- Keywords
- Pain, Nebulisation, Cholecystectomy, Laparoscopic, Bupivacaine, Local Anaesthetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 15 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.
Detailed description
Pain post laparoscopic procedures can be divided into access related, operation site and distension related. The access type can be attenuated by the use of sub dermal infiltration of local anaesthetic and rarely causes significant discomfort. It has been advocated that placement of a peritoneal gas drain significantly reduces postoperative pain particularly referred to the shoulder tip. Realistically, however, if attention is paid to expelling the residual gas at the end of the procedure this complication is rarely problematic. Operative site pain however is more difficult to manage. In limited gynaecological procedures it has been shown that local installation of local anaesthetic decreased the analgesic requirement of patients post operatively. These observations would not be as transferable to more extensive colorectal or solid organ surgery as the amount of local anaesthesia required would be toxic to the patient. Use of the nebuliser, however maybe able to alleviate pain by efficiently using the dosage required.
This is a prospective randomised double blind trial. Sixty patients will be allocated randomly between three groups, 20 patients in each group:
- Control group
- Nebulised intraperitoneal local anaesthetic (Bupivacaine 0.25%, 3mg/Kg)
- Nebulised intraperitoneal normal saline Ward staff will be blinded to which group the patients are in. All patients undergoing laparoscopic cholecystectomy who have given written, informed consent are eligible for inclusion. Patients with local anaesthetics allergy and patients whom pain evaluation is considered unreliable due to chronic opiate use or neurological diseases are excluded.
No pre-medication is to be given and a standardised anaesthetic technique is to be employed for all patients.
Standard 4 ports technique for laparoscopic cholecystectomy will be used with intraperitoneal pressure between 12-14 mmHg. This will be achieved using CO2 as the insufflation gas.
The local anaesthetic (approximately 10mls) will be delivered via a fine sterile catheter that will be inserted via the epigastric port under direct vision at the end of the procedure. Afterward the pneumoperitoneum will be deflated and the wound will be closed and subcutaneous local anaesthetic will be injected in and around the wounds.
Postoperatively, all the patients will have PCA as the main analgesia supported by NSAIDs unless contraindicated. Patients will eat and drink as desired and drips will be taken as soon as it is safe to do so.
Postoperative pain scoring will be stared in recovery and continue on the wards using the visual analogue scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Other: No Intraperitoneal TherapeuticsNo intraperitoneal therapeutics (No nebulised Bupivacaine) |
| IP Aerosolized Normal Saline | Placebo comparator | Drug: Normal SalineIntraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) |
| Nebulised Bupivacaine intraperitoneally | Experimental | Drug: Nebulised Bupivacaine intraperitoneallyIntraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) |
| Injected Bupivacaine intraperitoneally | Active comparator | Drug: Injected Bupivacaine intraperitoneallyIntraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All they patients undergoing laparoscopic cholecystectomy will be included.
Key exclusion criteria (1 listed)
- Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
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 |
|---|---|---|
| Nebulised Bupivacaine intraperitoneallyAlso: MarcaineNebulised Marcaine (Bupivacaine) | Drug | Nebulised Bupivacaine intraperitoneally |
| Normal SalineAlso: 0.9 % Normal SalineNebulised Normal Saline | Drug | IP Aerosolized Normal Saline |
| Injected Bupivacaine intraperitoneallyAlso: MarcaineInjected Marcaine directly into the peritoneal cavity | Drug | Injected Bupivacaine intraperitoneally |
| No Intraperitoneal TherapeuticsNo Intraperitoneal Therapeutics given | Other | Control |
Primary outcome
Reduction in Postoperative Pain
Time frame: 0 hours, 6 hours, 12 hours, 24 hours
Postoperative pain was measured using Pain scale 0-10 (0 = No Pain, 10 = Maximum pain). A trained nursing staff will ask the patient about his / her pain and document that correctly in the chart. The staff will also document if the patient requires any analgesia, the type and the dose.
3 secondary outcomes
Number of Vomiting / Nausea Episodes
Time frame: 24 hours
Hours Needed for Safe Mobilization
Time frame: 24 Hours
Postoperative Morphine Use
Time frame: 24 Hoiurs
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17180268Alkhamesi NA, Peck DH, Lomax D, Darzi AW. Intraperitoneal aerosolization of bupivacaine reduces postoperative pain in laparoscopic surgery: a randomized prospective controlled double-blinded clinical trial. Surg Endosc. 2007 Apr;21(4):602-6. doi: 10.1007/s00464-006-9087-6. Epub 2006 Dec 16.
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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.
Nawar A Alkhamesi, MD, PhD principal investigator
Imperial College London
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 Nebulised Bupivacaine intraperitoneally, Normal Saline and Injected Bupivacaine intraperitoneally in people with Pain, Postoperative, run by Imperial College London 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 1 inclusion and 1 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 15 Sep 2015. 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.
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?
Yes. Results are posted in the registry (first posted 15 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduction in Postoperative Pain (time frame: 0 hours, 6 hours, 12 hours, 24 hours). 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 NCT00180687, 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 15 Sep 2015.