A Phase 3 interventional study of Nebulised Bupivacaine intraperitoneally and Normal Saline in Pain, Postoperative, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-15.
Sponsored by Imperial College London · Phase 3, Interventional, and Treatment
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 80 is close to the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
No intraperitoneal therapeutics (No nebulised Bupivacaine)
Other: No Intraperitoneal Therapeutics
Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)
Drug: Normal Saline
Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)
Drug: Nebulised Bupivacaine intraperitoneally
Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)
Drug: Injected Bupivacaine intraperitoneally
Nebulised Marcaine (Bupivacaine)
Also known as: Marcaine
Nebulised Normal Saline
Also known as: 0.9 % Normal Saline
Injected Marcaine directly into the peritoneal cavity
Also known as: Marcaine
No Intraperitoneal Therapeutics given
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.
Time frame: 0 hours, 6 hours, 12 hours, 24 hours
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.
Time frame: 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.
Time frame: 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
Time frame: 24 Hoiurs
| Milestone | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Started | 20 | 20 | 20 | 20 |
| Completed | 20 | 20 | 20 | 20 |
| Not completed | 0 | 0 | 0 | 0 |
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.
| units on a scale | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Pain in Recovery (0 Hours) | 9.2 (3 to 10) | 10 (10 to 10) | 3.3 (1 to 10) | 9.3 (5 to 10) |
| Pain at 6 hours | 8.2 (5 to 10) | 8.1 (4 to 10) | 0.7 (0 to 3) | 7.2 (4 to 10) |
| Pain at 12 hours | 7.9 (3 to 10) | 8 (4 to 10) | 0.6 (0 to 3) | 6.7 (4 to 10) |
| Pain at 24 hours | 6.1 (4 to 10) | 6.2 (2 to 10) | 0.5 (0 to 3) | 5.6 (3 to 8) |
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.
| Number of vomitting / Nausea episodes | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Number of Vomiting / Nausea Episodes | 7.1 (5 to 9) | 7.1 (3 to 8) | 2 (0 to 4) | 6.8 (2 to 9) |
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.
| Hours needed for safe mobilization | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Hours Needed for Safe Mobilization | 6.7 (4 to 10) | 6.5 (4 to 11) | 3 (2 to 4) | 6.4 (3 to 9) |
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
| mg | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Postoperative Morphine Use | 25.9 (10 to 45) | 26.3 (10 to 50) | 1 (0 to 10) | 16.7 (8 to 30) |
Collected over 24 Hours. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control | — | 0/20 (0%) | 5/20 (25%) |
| IP Aerosolized Normal Saline | — | 0/20 (0%) | 5/20 (25%) |
| Nebulised Bupivacaine Intraperitoneally | — | 0/20 (0%) | 1/20 (5%) |
| Injected Bupivacaine Intraperitoneally | — | 0/20 (0%) | 5/20 (25%) |
| Event | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally |
|---|---|---|---|---|
| Nausea and VomitingGastrointestinal disorders | 5/20 | 5/20 | 1/20 | 5/20 |
| Age, Continuous(Years) | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally | Total |
|---|---|---|---|---|---|
| Mean | 47.65 (25 to 75) | 47.65 (26 to 74) | 51.60 (25 to 83) | 48.70 (34 to 79) | 49 (25 to 83) |
| Sex: Female, Male(Participants) | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally | Total |
|---|---|---|---|---|---|
| Female | 16 | 18 | 17 | 18 | 69 |
| Male | 4 | 2 | 3 | 2 | 11 |
| Region of Enrollment(participants) | Control | IP Aerosolized Normal Saline | Nebulised Bupivacaine Intraperitoneally | Injected Bupivacaine Intraperitoneally | Total |
|---|---|---|---|---|---|
| United Kingdom | 20 | 20 | 20 | 20 | 80 |
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Imperial College London