Laparoscopic Surgical ProceduresPhase 2NCT00280553
A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
A Phase 2 study testing bupivicaine and Saline infusion in people with Laparoscopic Surgical Procedures, run by Margherita CADDEDU at 1 site in Canada.
Trial summary
The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Laparoscopic Surgical Procedures
- What is being tested?
- bupivicaine and Saline infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2005to Apr 2013
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eligible and consented patients between the ages of 18 and 80
- male and female patients
- scheduled for elective laparoscopic colorectal resection
- anesthetist-assessed to be ASA 1-3
Who cannot join
- patients with allergies to medications used in study
- non-ambulatory patients
- patients with foreign bodies (ie. Orthopedics prostheses)
- patients requiring colostomies as part of procedure
- patients with enterocutaneous, entero-enteric, enterovaginal, enterovesicular, recto-vaginal, entero-utero fistulas
- pregnant patients
Show all 13Show fewer
- immuno-compromised patients
- patients with moderate to severe ascites or moderate to severe hepatic insufficiency
- patients unable to speak and comprehend English
- patients requiring emergency colorectal resection
- patients who, for medical reasons assessed by an anesthetist, are deemed deserving of epidural analgesia
- patients with seizure disorders
- patients assessed by an anesthetist to be ASA 4 or 5
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster University-St. Joseph's Healthcare
Hamilton, Ontario, L8N 4A6
Margherita Cadeddu, MD, 905-522-1155 ext. 34990, tuitem@mcmaster.ca
Karen Barlow, 905-522-1155 ext. 35067, kbarlow@mcmaster.ca
About this study
The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery.
The main research question is whether use of the pain pump will result in decreased hospital length of stay. The research is important because if the pain pump is found to be effective, it can substantially decrease the length of stay. Areas to be studied include hospital length of stay, patient's comfort post-operatively, and post-operative complications.
Read the detailed description
Pain in the post-operative period has been a limiting factor delaying recovery following abdominal surgery. Furthermore, it has been associated with several complications including ileus, urinary retention, delay to tolerating oral intake and enteral feeds, thrombo-embolic complications, and respiratory complications such as atelectasis and pneumonia. Diminishing pain in the post-operative period has been a subject of great study and to date the role of epidural analgesia, epidural anesthesia, patient controlled anesthesia and narcotic analgesia has been well documented to assist in controlling pain, decreasing morbidity and accelerating recovery in the post-operative period following colorectal surgery.
Nevertheless, the use of opioid-based analgesic techniques via epidural, nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea, vomiting, ileus, delay in tolerance or urinary retention. Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia. Recently, several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision. The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic, plastic, thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery.
The rational of the study is that bupivicaine infusion pumps are being used at St. Joseph's Healthcare for patients undergoing laparoscopic assisted colorectal surgery, and anecdotally, the patients have less pain, need less narcotics and can ambulate and be discharged sooner. This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patient's post-operative pain.
- Conditions
- Laparoscopic Surgical Procedures
- Being tested
- bupivicaine, Saline infusion
- Keywords
- analgesia, laparoscopic surgical procedures, length of stay
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivicaineDrug
PCA and bupivicaine infusion for up to five days
Saline infusionOther
PCA and pump with saline infusion for up to five days
| Study group | Role | What they receive |
|---|---|---|
| patient controlled analgesia (PCA) only | No intervention | Not described |
| PCA and pump with saline infusion for up to five days | Other | Not described Receives: Other: Saline infusion |
| PCA and bupivicaine infusion for up to five days | Other | Not described Receives: Drug: bupivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of stay postoperative in hospital
Measured: end of surgery to discharge
Secondary outcomes (3)
subjective pain of patient
Measured: Pre-op and post-op
incidence of in-hospital and post-discharge complications
Measured: Post-op days 1, 2, 3, 5 and 14
amount of narcotic and non-narcotic analgesia required
Measured: Post-op 1, 2, 3, 5 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startApr 2005
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Surgical ProceduresStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Margherita CADDEDU
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University, The Physicians' Services Incorporated Foundation, St. Joseph's Healthcare Hamilton
- Responsible party
- Sponsor-investigator, Margherita CADDEDU, McMaster University
- Investigators
- Margherita Cadeddu, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280553
- Sponsor's protocol ID
- 04-2399
- Status last verified
- May 2012
- First submitted
- 19 Jan 2006
- Last updated
- 15 May 2012
- Results posted
- No
Publications
Skinner HB, Shintani EY. Results of a multimodal analgesic trial involving patients with total hip or total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2004 Feb;33(2):85-92; discussion 92.
PubMed 15005598Carabine UA, Gilliland H, Johnston JR, McGuigan J. Pain relief for thoracotomy. Comparison of morphine requirements using an extrapleural infusion of bupivacaine. Reg Anesth. 1995 Sep-Oct;20(5):412-7.
PubMed 8519719Baroody M, Tameo MN, Dabb RW. Efficacy of the pain pump catheter in immediate autologous breast reconstruction. Plast Reconstr Surg. 2004 Sep 15;114(4):895-8; discussion 899-900. doi: 10.1097/01.prs.0000133173.71201.3c.
PubMed 15468395White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
PubMed 14508326Cheong WK, Seow-Choen F, Eu KW, Tang CL, Heah SM. Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy. Br J Surg. 2001 Mar;88(3):357-9. doi: 10.1046/j.1365-2168.2001.01717.x.
PubMed 11260098Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.
PubMed 15141043Ashcraft EE, Baillie GM, Shafizadeh SF, McEvoy JR, Mohamed HK, Lin A, Baliga PK, Rogers J, Rajagopalan PR, Chavin KD. Further improvements in laparoscopic donor nephrectomy: decreased pain and accelerated recovery. Clin Transplant. 2001;15 Suppl 6:59-61. doi: 10.1034/j.1399-0012.2001.00011.x.
PubMed 11903389Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
PubMed 1235985
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Bupivacaine Infusion in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT00280553
- Acronym / sponsor ID
- 04-2399
- Conditions
- Laparoscopic Surgical Procedures
- Keywords
- analgesia, laparoscopic surgical procedures, length of stay
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Margherita CADDEDUUniversity, hospital or other
- Collaborators
- McMaster University, The Physicians' Services Incorporated Foundation, St. Joseph's Healthcare Hamilton
- Study start
- Apr 2005
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 23 Jan 2006 (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.
The incisions used in abdominal surgery can be quite painful, requiring strong pain medications. A new pain pump that trickles small amounts of local freezing into the incision has been developed that helps numb the area so that the patient does not feel the pain for two to five days after surgery.
The main research question is whether use of the pain pump will result in decreased hospital length of stay. The research is important because if the pain pump is found to be effective, it can substantially decrease the length of stay. Areas to be studied include hospital length of stay, patient's comfort post-operatively, and post-operative complications.
Detailed description
Pain in the post-operative period has been a limiting factor delaying recovery following abdominal surgery. Furthermore, it has been associated with several complications including ileus, urinary retention, delay to tolerating oral intake and enteral feeds, thrombo-embolic complications, and respiratory complications such as atelectasis and pneumonia. Diminishing pain in the post-operative period has been a subject of great study and to date the role of epidural analgesia, epidural anesthesia, patient controlled anesthesia and narcotic analgesia has been well documented to assist in controlling pain, decreasing morbidity and accelerating recovery in the post-operative period following colorectal surgery.
Nevertheless, the use of opioid-based analgesic techniques via epidural, nurse or patient controlled delivery systems either oral or parenteral can produce adverse effects such as nausea, vomiting, ileus, delay in tolerance or urinary retention. Concomitant use of non-narcotic based analgesics have failed to obviate the need for narcotic based analgesia. Recently, several companies have developed devices that deliver a constant rate of local anesthetic via a spring loaded device through a multiport catheter inserted into the incision. The effectiveness of these bupivicaine infusion pumps has been demonstrated to diminish post-operative pain following orthopedic, plastic, thoracic and cardiac surgeries but to date their role has not been evaluated in colorectal surgery or abdominal surgery.
The rational of the study is that bupivicaine infusion pumps are being used at St. Joseph's Healthcare for patients undergoing laparoscopic assisted colorectal surgery, and anecdotally, the patients have less pain, need less narcotics and can ambulate and be discharged sooner. This pilot study aims to gather prospective randomized data regarding post-operative length of stay and patient pain scores so that a properly powered randomization study can be undertaken to understand if the bupivicaine infusion system helps decrease length of stay and patient's post-operative pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient controlled analgesia (PCA) only | No intervention | – |
| PCA and pump with saline infusion for up to five days | Other | Other: Saline infusion |
| PCA and bupivicaine infusion for up to five days | Other | Drug: bupivicaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- eligible and consented patients between the ages of 18 and 80
- male and female patients
- scheduled for elective laparoscopic colorectal resection
- anesthetist-assessed to be ASA 1-3
Key exclusion criteria (13 listed)
- patients with allergies to medications used in study
- non-ambulatory patients
- patients with foreign bodies (ie. Orthopedics prostheses)
- patients requiring colostomies as part of procedure
- patients with enterocutaneous, entero-enteric, enterovaginal, enterovesicular, recto-vaginal, entero-utero fistulas
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 |
|---|---|---|
| bupivicainePCA and bupivicaine infusion for up to five days | Drug | PCA and bupivicaine infusion for up to five days |
| Saline infusionPCA and pump with saline infusion for up to five days | Other | PCA and pump with saline infusion for up to five days |
Primary outcome
length of stay postoperative in hospital
Time frame: end of surgery to discharge
3 secondary outcomes
subjective pain of patient
Time frame: Pre-op and post-op
incidence of in-hospital and post-discharge complications
Time frame: Post-op days 1, 2, 3, 5 and 14
amount of narcotic and non-narcotic analgesia required
Time frame: Post-op 1, 2, 3, 5 and 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2012.
- Background: PubMed 15005598Skinner HB, Shintani EY. Results of a multimodal analgesic trial involving patients with total hip or total knee arthroplasty. Am J Orthop (Belle Mead NJ). 2004 Feb;33(2):85-92; discussion 92.
- Background: PubMed 8519719Carabine UA, Gilliland H, Johnston JR, McGuigan J. Pain relief for thoracotomy. Comparison of morphine requirements using an extrapleural infusion of bupivacaine. Reg Anesth. 1995 Sep-Oct;20(5):412-7.
- Background: PubMed 15468395Baroody M, Tameo MN, Dabb RW. Efficacy of the pain pump catheter in immediate autologous breast reconstruction. Plast Reconstr Surg. 2004 Sep 15;114(4):895-8; discussion 899-900. doi: 10.1097/01.prs.0000133173.71201.3c.
- Background: PubMed 14508326White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C. Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology. 2003 Oct;99(4):918-23. doi: 10.1097/00000542-200310000-00026.
- Background: PubMed 11260098Cheong WK, Seow-Choen F, Eu KW, Tang CL, Heah SM. Randomized clinical trial of local bupivacaine perfusion versus parenteral morphine infusion for pain relief after laparotomy. Br J Surg. 2001 Mar;88(3):357-9. doi: 10.1046/j.1365-2168.2001.01717.x.
- Background: PubMed 15141043Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.
- Background: PubMed 11903389Ashcraft EE, Baillie GM, Shafizadeh SF, McEvoy JR, Mohamed HK, Lin A, Baliga PK, Rogers J, Rajagopalan PR, Chavin KD. Further improvements in laparoscopic donor nephrectomy: decreased pain and accelerated recovery. Clin Transplant. 2001;15 Suppl 6:59-61. doi: 10.1034/j.1399-0012.2001.00011.x.
- Background: PubMed 1235985Melzack R. The McGill Pain Questionnaire: major properties and scoring methods. Pain. 1975 Sep;1(3):277-299. doi: 10.1016/0304-3959(75)90044-5.
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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.
Margherita Cadeddu, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bupivicaine and Saline infusion in people with Laparoscopic Surgical Procedures, run by Margherita CADDEDU at 1 site in Canada.
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 4 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 15 May 2012. 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 Canada. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margherita Cadeddu, MD (905-522-1155 ext. 4990, tuitem@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
length of stay postoperative in hospital (time frame: end of surgery to 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 NCT00280553, which also lists 8 linked publications.
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 May 2012.