Postoperative PainPhase 4NCT01960049
Novel Technique of Analgesia Following Open Liver Resection
A Phase 4 study testing ropivacaine + iv PCA and saline and IV PCA in people with Postoperative Pain and Liver Resection, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Liver Resection
- What is being tested?
- ropivacaine + iv PCA and saline and IV PCA
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >18 years age
- Undergoing liver resection using a subcostal incision
Who cannot join
- Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
- Allergy to any study medications
- Patient not able to be extubated postoperatively for any clinical reason
- Laparoscopic surgery
- Co-existing epidural or intrathecal analgesia
- Chronic pain disorders or on long-term opioid use
Show all 9Show fewer
- History of substance or alcohol abuse
- Transplant donor liver resections
- Patients with liver cirrhosis
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Sunnybrook Health Science Centre
Toronto, Ontario
About this study
Official title: Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters
Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.
- Conditions
- Postoperative Pain, Liver Resection
- Being tested
- ropivacaine + iv PCA, saline and IV PCA
- Keywords
- Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine + iv PCAProcedure or surgery
saline and IV PCAProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| MOTAP Catheter with Saline and IV PCA | Placebo comparator | Control group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours Receives: Procedure: saline and IV PCA |
| MOTAP catheter with ropivocaine and IV PCA | Active comparator | 20cc of 0.2% ropivacaine will be injected in two equal divided doses through the two catheters then run at 5ml/hr for 72 hours Receives: Procedure: ropivacaine + iv PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption
The primary endpoint is mean cumulative postoperative opioid consumption over the first two postoperative days (48 hours). Both intravenous PCA opioids and oral opioids will be recorded from the patient's medical records daily, converted to morphine equivalents, and compared between the two groups.
The following information will be collected at regular intervals as a measure of the primary endpoints: Cumulative i.v. PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
Measured: PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hance Clarke, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960049
- Sponsor's protocol ID
- 12-0493-A
- Status last verified
- May 2016
- First submitted
- 23 Sep 2013
- Last updated
- 1 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Page MG, Karanicolas PJ, Cleary S, Wei AC, McHardy P, Ladak SSJ, Ayach N, Sawyer J, McCluskey SA, Srinivas C, Katz J, Coburn N, Hallet J, Law C, Greig P, Clarke H. In-hospital opioid consumption, but not pain intensity scores, predicts 6-month levels of pain catastrophizing following hepatic resection: A trajectory analysis. Eur J Pain. 2019 Mar;23(3):503-514. doi: 10.1002/ejp.1324. Epub 2018 Nov 8.
PubMed 30298685Karanicolas PJ, Cleary S, McHardy P, Kiss A, Sawyer J, Behman R, Ladak S, McCluskey SA, Srinivas C, Katz J, Coburn N, Law C, Wei AC, Greig P, Hallet J, Clarke H. Medial Open Transversus Abdominis Plane (MOTAP) Catheters Reduce Opioid Requirements and Improve Pain Control Following Open Liver Resection: A Multicenter, Blinded, Randomized Controlled Trial. Ann Surg. 2018 Aug;268(2):233-240. doi: 10.1097/SLA.0000000000002657.
PubMed 29300708Karanicolas P, Cleary S, McHardy P, McCluskey S, Sawyer J, Ladak S, Law C, Wei A, Coburn N, Ko R, Katz J, Kiss A, Khan J, Coimbatore S, Lam-McCulloch J, Clarke H. Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:241. doi: 10.1186/1745-6215-15-241.
PubMed 24950773
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Evaluation of a Novel Technique of Analgesia Following Open Liver Resection: Medial Open Transversus Abdominis Plane (MOTAP) Catheters
- ClinicalTrials.gov ID
- NCT01960049
- Acronym / sponsor ID
- 12-0493-A
- Conditions
- Postoperative Pain, Liver Resection
- Keywords
- Postoperative pain, Liver resection, Medial Open Transversus Abdominis Plane catheter
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Oct 2013 (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.
Abdominal wall incisions used for liver surgeries are associated with significant postoperative pain and disability. Epidural analgesia is often contraindicated in these patients due to common bleeding problems. Furthermore, drugs such as acetaminophen and opioids are often inadequate and can lead to detrimental side-effects. Abdominal wall (AW) catheters can be placed during surgical closure along the incision line and can be used to administer local anesthetics for postoperative pain. The study is a multi-centre, double-blind, randomized controlled trial involving 120 patients undergoing elective liver surgery. Patients will be randomly assigned to AW catheter group treated with drug or control treated with saline. Treatment group will receive AW catheters with ropivacaine plus standard patient controlled analgesia (PCA). Control group will obtain AW with normal saline and no local anesthetics and PCA. Patients are followed for 6 months post-operatively for pain scores, side-effects, chronic pain and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MOTAP Catheter with Saline and IV PCA | Placebo comparator | Procedure: saline and IV PCAControl group will have saline 20cc of 0.9% normal saline injected into the catheters and then run at 5ml/hr for 72 hours |
| MOTAP catheter with ropivocaine and IV PCA | Active comparator | Procedure: ropivacaine + iv PCA20cc of 0.2% ropivacaine will be injected in two equal divided doses through the two catheters then run at 5ml/hr for 72 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- >18 years age
- Undergoing liver resection using a subcostal incision
Key exclusion criteria (9 listed)
- Patients unable to comprehend instructions, consent, or co-operate with pain assessment (including psychiatric disorders, pre-operative sedation, coma)
- Allergy to any study medications
- Patient not able to be extubated postoperatively for any clinical reason
- Laparoscopic surgery
- Co-existing epidural or intrathecal analgesia
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 |
|---|---|---|
| ropivacaine + iv PCA | Procedure or surgery | MOTAP catheter with ropivocaine and IV PCA |
| saline and IV PCA | Procedure or surgery | MOTAP Catheter with Saline and IV PCA |
Primary outcome
Opioid consumption
Time frame: PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
The primary endpoint is mean cumulative postoperative opioid consumption over the first two postoperative days (48 hours). Both intravenous PCA opioids and oral opioids will be recorded from the patient's medical records daily, converted to morphine equivalents, and compared between the two groups. The following information will be collected at regular intervals as a measure of the primary endpoints: Cumulative i.v. PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.
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 1 Aug 2017.
- Derived from this study: PubMed 30298685Page MG, Karanicolas PJ, Cleary S, Wei AC, McHardy P, Ladak SSJ, Ayach N, Sawyer J, McCluskey SA, Srinivas C, Katz J, Coburn N, Hallet J, Law C, Greig P, Clarke H. In-hospital opioid consumption, but not pain intensity scores, predicts 6-month levels of pain catastrophizing following hepatic resection: A trajectory analysis. Eur J Pain. 2019 Mar;23(3):503-514. doi: 10.1002/ejp.1324. Epub 2018 Nov 8.
- Derived from this study: PubMed 29300708Karanicolas PJ, Cleary S, McHardy P, Kiss A, Sawyer J, Behman R, Ladak S, McCluskey SA, Srinivas C, Katz J, Coburn N, Law C, Wei AC, Greig P, Hallet J, Clarke H. Medial Open Transversus Abdominis Plane (MOTAP) Catheters Reduce Opioid Requirements and Improve Pain Control Following Open Liver Resection: A Multicenter, Blinded, Randomized Controlled Trial. Ann Surg. 2018 Aug;268(2):233-240. doi: 10.1097/SLA.0000000000002657.
- Derived from this study: PubMed 24950773Karanicolas P, Cleary S, McHardy P, McCluskey S, Sawyer J, Ladak S, Law C, Wei A, Coburn N, Ko R, Katz J, Kiss A, Khan J, Coimbatore S, Lam-McCulloch J, Clarke H. Medial open transversus abdominis plane (MOTAP) catheters for analgesia following open liver resection: study protocol for a randomized controlled trial. Trials. 2014 Jun 21;15:241. doi: 10.1186/1745-6215-15-241.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Hance Clarke, MD principal investigator
Toronto General Hospital, University Health Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ropivacaine + iv PCA and saline and IV PCA in people with Postoperative Pain and Liver Resection, run by University Health Network, Toronto at 2 sites 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 2 inclusion and 9 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 1 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Opioid consumption (time frame: PCA opioid consumption every 12 hours for 72 hours as well as total opioid consumption for the entire hospital stay.). 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 NCT01960049, which also lists 3 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 1 Aug 2017.