Surgical WoundCLoWINCT04503720
CLoWI Versus PCA Morphine for Pain Control After Major Abdominal Surgery
A study testing CLoWI and PCA in people with Surgical Wound and Post-Op Complication, run by JurongHealth at 2 sites in Singapore.
Trial summary
Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery. Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Surgical Wound, Post-Op Complication, Opioid Use
- What is being tested?
- CLoWI and PCA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Dec 2017to 30 Jun 2022
- Phase
- Interventional
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned for elective or urgent# open abdominal surgery
- Abdominal Surgery may include the following procedures:
- Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery
- Ability to provide informed consent. A signed and dated written informed consent prior to study participation.
- Age 21 to 80 years for both males and females
Who cannot join
- Female subject who is pregnant
- Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy.
- Known allergy to local anaesthetic or opioid drugs (Morphine).
- Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery.
- Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc.
- Severe associated acute illness American Society of Anesthesiologists (ASA) Grade 4 or 5 where survival following surgery is not expected
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore, 119074
Ng Teng Fong General Hospital
Singapore, 609606
About this study
Official title: Continuous Local Anaesthetic Wound Infusion (CLoWI) Versus PCA Morphine for Pain Control After Major Abdominal Surgery:A Double Blinded, Randomized, Controlled, Non Inferiority Trial (CLoWI Trial)
Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery.
Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). The use of CLoWI negates the side-effects of opioids, and will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
Read the detailed description
Major intra-abdominal surgery represents one of the commonest groups of surgical procedures performed both worldwide and within Singapore. Common general surgical conditions requiring major intra-abdominal surgery include intestinal pathologies such as cancer, ischaemia, infection, haemorrhage and perforation.
Major surgery within the abdominal cavity is associated with significant complications which may be life threatening with an associated hospital mortality rate of as high as 20% for emergency surgery. Importantly, the recovery from this type of major surgery often entails significant pain and discomfort for the patient during healing of the abdominal wound and internal organs from tissue trauma associated with these surgical procedures.
Recent developments in major intra-abdominal surgery have demonstrated the importance of the early surgical recovery period where common postoperative complications including pain, chest infection, intestinal ileus and delerium are not only associated with prolonged hospital stay but are harbingers of poor long term surgical outcomes. Current recommendations for perioperative management of patients undergoing major intra-abdominal surgery stress the importance of high quality perioperative care to minimise these sequelae. Key features of these recommendations are to provide a pain free postoperative surgical recovery with minimal nausea and vomiting to facilitate early mobilisation and functional recovery from surgery.
Patient controlled analgesia (PCA) with opioids is the first line analgesia therapy currently used in the immediate post-operative period following major abdominal surgery. PCA with opioids has some inherent disadvantages that include side-effects of opioids such as nausea, vomiting, prolonged ileus, dizziness, hallucination and respiratory depression with the need for supplementary oxygen. This is most pertinent in elderly patients who are more prone to these side-effects in addition to being more likely to have difficulties in understanding how to use the PCA and so are more vulnerable to inadequate pain control. Consequently, there may be a delay in resuming mobility and discharge from hospital.
Continuous local wound infusion (CLoWI) with Ropivacaine that is delivered into the extraperitoneal plane via an ON-Q® (Halyard) infusion pump has been shown to be an effective analgesia post-operatively. The use of CLoWI negates the side-effects of opioids and furthermore, the small portable pump allows early ambulation with no requirement for supplementary oxygen. Previous published research has demonstrated the benefits of continuous local wound infusion with local anaesthesia in terms of postoperative analgesia and surgical recovery However, there are no randomized controlled trials comparing PCA versus continuous local wound infusion alone; this study will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
The local anaesthetic drug to be used for the wound infiltration system is Ropivacaine. Its mechanism of action involves inhibiting sodium influx through sodium-specific ion channels in the peripheral nerve axonal cell membrane, in particular, the voltage gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and the conduction of a pain signal is inhibited. The local anaesthetic will be administered via 2 catheters that will be placed under direct vision by the surgeon at the time of wound closure.
Ropivacaine 0.5% will be infused at a rate of 4mls/hour (2mls/hour in each catheter) for a total of 4 days. It is currently in clinical use within our hospital as a routine method of providing postoperative analgesia following major abdominal surgery.
- Conditions
- Surgical Wound, Post-Op Complication, Opioid Use
- Being tested
- CLoWI, PCA
- Keywords
- continuous local wound infusion, opioids, post-operative pain, surgical incision
- Medical subject headings
- Surgical Wound, Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLoWIDevice
Patients will receive a continuous wound infusion with ropivacaine and normal saline in the PCA pump.
PCADevice
Patients will receive a continuous wound infusion with normal saline and morphine in the PCA pump.
| Study group | Role | What they receive |
|---|---|---|
| CLoWI | Experimental | CLoWI (ropivacaine) and PCA (normal saline)
The local anaesthetic infusion will be administered via 2 catheters using a ON-Q® (Halyard) delivery system that will be placed under direct vision by the surgeon at the time of wound closure. 40 mls of 0.25% ropivacaine are infiltrated in the preperitoneal plane. 0.5% ropivacaine will be infused at a rate of 4mls/hour (2mls/hour in each catheter).
The dosage 40 mls of 0.25% ropivacaine and 0.5% ropivacaine at 4mls/hr (20mg/hr) over 4 days will be less than the recommended toxic dose of 3-4 mg/kg. Receives: Device: CLoWI |
| PCA | Active comparator | PCA (Morphine) and CLoWI (normal saline)
Morphine will be administered via the standard PCA protocol in accordance to the hospital's Acute Pain Service Programme:
* Concentration: 1mg/ml
* Bolus (Loading): 1mg
* Lockout Interval: 5 minutes
* Maximum hourly dose of 10mg Receives: Device: PCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare CLoWI and PCA (Morphine) in terms of post operative pain control
To determine if wither CLoWI or PCA will achieve better post-operative pain control based on a numerical rating score from 0 - 10
Measured: 5 days
Secondary outcomes (2)
To compare CLoWI and PCA (Morphine) in terms of post operative complication rates associated with opioid usage
This includes the following complications - urinary retention, time to flatus, time to bowel opening, nausea and vomiting.
Measured: 5 days
To compare CLoWI and PCA (Morphine) in terms of the length of postoperative hospital stay.
This takes into account the length of time the patient spends in the hospital between the two arms.
Measured: from the time of surgery till discharge, an average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start1 Dec 2017
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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 Surgical WoundStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- JurongHealth
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christopher Keh, FRCS, Principal investigator, Ng Teng Fong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503720
- Sponsor's protocol ID
- Juronghealth
- Acronym
- CLoWI
- Status last verified
- Jul 2024
- First submitted
- 26 Feb 2020
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liang SS, Ying AJ, Affan ET, Kakala BF, Strippoli GF, Bullingham A, Currow H, Dunn DW, Yeh ZY. Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults. Cochrane Database Syst Rev. 2019 Oct 19;10(10):CD012310. doi: 10.1002/14651858.CD012310.pub2.
PubMed 31627242Prochazka V, Svoboda M, Svaton R, Grolich T, Farkasova M, Kala Z. Use of preperitoneal wound catheter for continuous local anaesthesia after laparoscopic colorectal surgery. Rozhl Chir. 2019 Summer;98(9):356-361. doi: 10.33699/PIS.2019.98.9.356-361.
PubMed 31698911Dalmau A, Fustran N, Camprubi I, Sanzol R, Redondo S, Ramos E, Torras J, Sabate A. Analgesia with continuous wound infusion of local anesthetic versus saline: Double-blind randomized, controlled trial in hepatectomy. Am J Surg. 2018 Jan;215(1):138-143. doi: 10.1016/j.amjsurg.2017.09.007. Epub 2017 Sep 20.
PubMed 28958651
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Local Anaesthetic Wound Infusion (CLoWI) Versus PCA Morphine for Pain Control After Major Abdominal Surgery:A Double Blinded, Randomized, Controlled, Non Inferiority Trial (CLoWI Trial)
- ClinicalTrials.gov ID
- NCT04503720
- Acronym / sponsor ID
- CLoWI / Juronghealth
- Conditions
- Surgical Wound, Post-Op Complication, Opioid Use
- Keywords
- continuous local wound infusion, opioids, post-operative pain, surgical incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- JurongHealthOther government
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 7 Aug 2020 (actual)
- 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.
Major abdominal surgery is associated with significant complications which may lead to morbidity and mortality. Pain experienced after surgery affects the recovery from surgery.
Our study aims to evaluate the current gold standard of PCA morphine infusion against a continuous wound infusion (CLoWI). The use of CLoWI negates the side-effects of opioids, and will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
Detailed description
Major intra-abdominal surgery represents one of the commonest groups of surgical procedures performed both worldwide and within Singapore. Common general surgical conditions requiring major intra-abdominal surgery include intestinal pathologies such as cancer, ischaemia, infection, haemorrhage and perforation.
Major surgery within the abdominal cavity is associated with significant complications which may be life threatening with an associated hospital mortality rate of as high as 20% for emergency surgery. Importantly, the recovery from this type of major surgery often entails significant pain and discomfort for the patient during healing of the abdominal wound and internal organs from tissue trauma associated with these surgical procedures.
Recent developments in major intra-abdominal surgery have demonstrated the importance of the early surgical recovery period where common postoperative complications including pain, chest infection, intestinal ileus and delerium are not only associated with prolonged hospital stay but are harbingers of poor long term surgical outcomes. Current recommendations for perioperative management of patients undergoing major intra-abdominal surgery stress the importance of high quality perioperative care to minimise these sequelae. Key features of these recommendations are to provide a pain free postoperative surgical recovery with minimal nausea and vomiting to facilitate early mobilisation and functional recovery from surgery.
Patient controlled analgesia (PCA) with opioids is the first line analgesia therapy currently used in the immediate post-operative period following major abdominal surgery. PCA with opioids has some inherent disadvantages that include side-effects of opioids such as nausea, vomiting, prolonged ileus, dizziness, hallucination and respiratory depression with the need for supplementary oxygen. This is most pertinent in elderly patients who are more prone to these side-effects in addition to being more likely to have difficulties in understanding how to use the PCA and so are more vulnerable to inadequate pain control. Consequently, there may be a delay in resuming mobility and discharge from hospital.
Continuous local wound infusion (CLoWI) with Ropivacaine that is delivered into the extraperitoneal plane via an ON-Q® (Halyard) infusion pump has been shown to be an effective analgesia post-operatively. The use of CLoWI negates the side-effects of opioids and furthermore, the small portable pump allows early ambulation with no requirement for supplementary oxygen. Previous published research has demonstrated the benefits of continuous local wound infusion with local anaesthesia in terms of postoperative analgesia and surgical recovery However, there are no randomized controlled trials comparing PCA versus continuous local wound infusion alone; this study will be the first randomised controlled trial to compare PCA (Morphine) with CLoWI-LA (Ropivacaine).
The local anaesthetic drug to be used for the wound infiltration system is Ropivacaine. Its mechanism of action involves inhibiting sodium influx through sodium-specific ion channels in the peripheral nerve axonal cell membrane, in particular, the voltage gated sodium channels. When the influx of sodium is interrupted, an action potential cannot arise and the conduction of a pain signal is inhibited. The local anaesthetic will be administered via 2 catheters that will be placed under direct vision by the surgeon at the time of wound closure.
Ropivacaine 0.5% will be infused at a rate of 4mls/hour (2mls/hour in each catheter) for a total of 4 days. It is currently in clinical use within our hospital as a routine method of providing postoperative analgesia following major abdominal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLoWI | Experimental | Device: CLoWICLoWI (ropivacaine) and PCA (normal saline) The local anaesthetic infusion will be administered via 2 catheters using a ON-Q® (Halyard) delivery system that will be placed under direct vision by the surgeon at the time of wound closure. 40 mls of 0.25% ropivacaine are infiltrated in the preperitoneal plane. 0.5% ropivacaine will be infused at a rate of 4mls/hour (2mls/hour in each catheter). The dosage 40 mls of 0.25% ropivacaine and 0.5% ropivacaine at 4mls/hr (20mg/hr) over 4 days will be less than the recommended toxic dose of 3-4 mg/kg. |
| PCA | Active comparator | Device: PCAPCA (Morphine) and CLoWI (normal saline) Morphine will be administered via the standard PCA protocol in accordance to the hospital's Acute Pain Service Programme: * Concentration: 1mg/ml * Bolus (Loading): 1mg * Lockout Interval: 5 minutes * Maximum hourly dose of 10mg |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Planned for elective or urgent# open abdominal surgery
- Urgent laparotomy for perforated viscus, intestinal obstruction. B) Elective abdominal surgery for upper and lower gastrointestinal surgery
- Ability to provide informed consent. A signed and dated written informed consent prior to study participation.
- Age 21 to 80 years for both males and females
Key exclusion criteria (6 listed)
- Female subject who is pregnant
- Inability to comply with PCA instructions due to physical disabilities. For example, visual or hearing impairment, arthritis, peripheral neuropathy.
- Known allergy to local anaesthetic or opioid drugs (Morphine).
- Current or recent on opioid therapy. For example due to chronic pain illness, opioid (or other) drug abuse or recent surgery.
- Severe comorbid diseases including liver cirrhosis, renal failure requiring dialysis, Grade 4 NYHA (New Yoke Heart Association) heart failure, respiratory illness requiring NIV (Non-Invasive Ventilation), etc.
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 |
|---|---|---|
| CLoWIPatients will receive a continuous wound infusion with ropivacaine and normal saline in the PCA pump. | Device | CLoWI |
| PCAPatients will receive a continuous wound infusion with normal saline and morphine in the PCA pump. | Device | PCA |
Primary outcome
To compare CLoWI and PCA (Morphine) in terms of post operative pain control
Time frame: 5 days
To determine if wither CLoWI or PCA will achieve better post-operative pain control based on a numerical rating score from 0 - 10
2 secondary outcomes
To compare CLoWI and PCA (Morphine) in terms of post operative complication rates associated with opioid usage
Time frame: 5 days
To compare CLoWI and PCA (Morphine) in terms of the length of postoperative hospital stay.
Time frame: from the time of surgery till discharge, an average of 5 days
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 12 Jul 2024.
- Background: PubMed 31627242Liang SS, Ying AJ, Affan ET, Kakala BF, Strippoli GF, Bullingham A, Currow H, Dunn DW, Yeh ZY. Continuous local anaesthetic wound infusion for postoperative pain after midline laparotomy for colorectal resection in adults. Cochrane Database Syst Rev. 2019 Oct 19;10(10):CD012310. doi: 10.1002/14651858.CD012310.pub2.
- Background: PubMed 31698911Prochazka V, Svoboda M, Svaton R, Grolich T, Farkasova M, Kala Z. Use of preperitoneal wound catheter for continuous local anaesthesia after laparoscopic colorectal surgery. Rozhl Chir. 2019 Summer;98(9):356-361. doi: 10.33699/PIS.2019.98.9.356-361.
- Background: PubMed 28958651Dalmau A, Fustran N, Camprubi I, Sanzol R, Redondo S, Ramos E, Torras J, Sabate A. Analgesia with continuous wound infusion of local anesthetic versus saline: Double-blind randomized, controlled trial in hepatectomy. Am J Surg. 2018 Jan;215(1):138-143. doi: 10.1016/j.amjsurg.2017.09.007. Epub 2017 Sep 20.
- Individual participant dataSharing planned: No
Related trials for Surgical Wound
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
SIRI Levels Following PENG Block in Pediatric Hip Surgery
Hip Dysplasia
RecruitingPhase 4
PENG With LFCB vs. ESP Blocks for Pediatric Hip Surgery
Hip Disease, Hip Dysplasia
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
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.
Christopher Keh, FRCS principal investigator
Ng Teng Fong General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLoWI and PCA in people with Surgical Wound and Post-Op Complication, run by JurongHealth at 2 sites in Singapore.
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 5 inclusion and 6 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 12 Jul 2024. 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 Singapore. 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.
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?
To compare CLoWI and PCA (Morphine) in terms of post operative pain control (time frame: 5 days). 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 NCT04503720, 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 12 Jul 2024.