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| ID | Type | Description | Link |
|---|---|---|---|
| Dr. David Peck | Other Identifier | Imperial College London | |
| Prof. Sir Ara Darzi | Other Identifier | Imperial College London |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | No intraperitoneal therapeutics (No nebulised Bupivacaine) |
|
| IP Aerosolized Normal Saline | Placebo Comparator | Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) |
|
| Nebulised Bupivacaine intraperitoneally | Experimental | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) |
|
| Injected Bupivacaine intraperitoneally | Active Comparator | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nebulised Bupivacaine intraperitoneally | Drug | Nebulised Marcaine (Bupivacaine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 hours, 6 hours, 12 hours, 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nawar A Alkhamesi, MD, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Mary's Hospital | London | W2 1NY | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17180268 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given |
| FG001 | IP Aerosolized Normal Saline | Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline |
| FG002 | Nebulised Bupivacaine Intraperitoneally | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine) |
| FG003 | Injected Bupivacaine Intraperitoneally | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given |
| BG001 | IP Aerosolized Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Full Range | units on a scale | 0 hours, 6 hours, 12 hours, 24 hours |
|
24 Hours
Nausea and Vomiting
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | No intraperitoneal therapeutics (No nebulised Bupivacaine) No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea and Vomiting | Gastrointestinal disorders | Patient Chart | Systematic Assessment | Number of Nausea / vomiting episodes recorded in patient's chart |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Nawar Alkhamesi | Imperial College London | 442033121110 | n.alkhamesi@imperial.ac.uk |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D010146 | Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline | Drug | Nebulised Normal Saline |
|
|
| Injected Bupivacaine intraperitoneally | Drug | Injected Marcaine directly into the peritoneal cavity |
|
|
| No Intraperitoneal Therapeutics | Other | No Intraperitoneal Therapeutics given |
|
| 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. | 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 | 24 Hoiurs |
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Normal Saline: Nebulised Normal Saline
| BG002 | Nebulised Bupivacaine Intraperitoneally | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine) |
| BG003 | Injected Bupivacaine Intraperitoneally | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Nebulised Bupivacaine Intraperitoneally | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine) |
| OG003 | Injected Bupivacaine Intraperitoneally | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity |
|
|
| Secondary | 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. | Posted | Mean | Full Range | Number of vomitting / Nausea episodes | 24 hours |
|
|
|
| Secondary | 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. | Posted | Mean | Full Range | Hours needed for safe mobilization | 24 Hours |
|
|
|
| Secondary | 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 | Posted | Mean | Full Range | mg | 24 Hoiurs |
|
|
|
| 0 |
| 20 |
| 5 |
| 20 |
| EG001 | IP Aerosolized Normal Saline | Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine) Normal Saline: Nebulised Normal Saline | 0 | 20 | 5 | 20 |
| EG002 | Nebulised Bupivacaine Intraperitoneally | Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine) Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine) | 0 | 20 | 1 | 20 |
| EG003 | Injected Bupivacaine Intraperitoneally | Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine) Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity | 0 | 20 | 5 | 20 |
|
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| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |