Upper Gastrointestinal SurgeryNCT02782767
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
A study testing Wound catheter infusion and Epidural infusion in people with Upper Gastrointestinal Surgery and Post-operative Analgesia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site} Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter
- What is being tested?
- Wound catheter infusion and Epidural infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- May 2016to Jan 2017
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision
Who cannot join
- Refusal to give consent.
- Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
- Addiction to opioids, or alcohol, or history of any other substance abuse.
- Allergy to local anaesthetic drugs.
- Pregnancy.
- Inability to communicate (e.g. known psychiatric disorders)
Trial locations and contacts
1 site in 1 country.
About this study
Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}
- Conditions
- Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter, Upper Midline Incision
- Being tested
- Wound catheter infusion, Epidural infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound catheter infusionOther
Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.
Epidural infusionOther
Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given
| Study group | Role | What they receive |
|---|---|---|
| Epidural catheter infusion | Active comparator | epidural catheter in the thoracic vertebra level to provide local anesthetic infusion Receives: Other: Epidural infusion |
| Wound catheter infusion | Experimental | A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion Receives: Other: Wound catheter infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS (Numerical Rating Score) in the two groups postoperatively
Measured: 24 hrs post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal SurgeryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arun Raja T, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Arun Raja Thangavel, MBBS, Principal investigator, Junior Resident , MD Anaesthesia and Intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782767
- Sponsor's protocol ID
- MDTG105
- Status last verified
- Feb 2017
- First submitted
- 18 May 2016
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02782767
- Acronym / sponsor ID
- MDTG105
- Conditions
- Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter, Upper Midline Incision
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 25 May 2016 (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.
Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural catheter infusion | Active comparator | Other: Epidural infusionepidural catheter in the thoracic vertebra level to provide local anesthetic infusion |
| Wound catheter infusion | Experimental | Other: Wound catheter infusionA multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision
Key exclusion criteria (6 listed)
- Refusal to give consent.
- Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
- Addiction to opioids, or alcohol, or history of any other substance abuse.
- Allergy to local anaesthetic drugs.
- Pregnancy.
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 |
|---|---|---|
| Wound catheter infusionWound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter. | Other | Wound catheter infusion |
| Epidural infusionEpidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given | Other | Epidural catheter infusion |
Primary outcome
NRS (Numerical Rating Score) in the two groups postoperatively
Time frame: 24 hrs post surgery
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 7 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Arun Raja Thangavel, MBBS principal investigator
Junior Resident , MD Anaesthesia and Intensive care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound catheter infusion and Epidural infusion in people with Upper Gastrointestinal Surgery and Post-operative Analgesia, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
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 1 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 7 Feb 2017. 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 India. 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?
NRS (Numerical Rating Score) in the two groups postoperatively (time frame: 24 hrs post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2017.