Abdominal NeoplasmsNCT03002909
Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery
A study testing epidural catheter and preperitoneal catheter in people with Abdominal Neoplasms, run by Assiut University at 1 site in Egypt.
Trial summary
the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Abdominal Neoplasms
- What is being tested?
- epidural catheter and preperitoneal catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2017to Jun 2018
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ASA I-III patients
- aged 18-60 yr
- undergo open abdominal cancer surgery
Who cannot join
- general contraindications for epidural analgesia,
- recent history (8 weeks) of, chemotherapy or radiation,
- chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy
the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy
- Conditions
- Abdominal Neoplasms
- Being tested
- epidural catheter, preperitoneal catheter
- Medical subject headings
- Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epidural catheterDevice
Also called PEA block
preperitoneal catheterDevice
Also called preperitoneal infusion
| Study group | Role | What they receive |
|---|---|---|
| epidural group | Active comparator | an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. . Receives: Device: epidural catheter |
| preperitoneal group | Active comparator | preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision. Receives: Device: preperitoneal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the level of inflammatory cytokines in pg /ml
Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines
Measured: 24 hours
Secondary outcomes (3)
Visual Analog Scale at rest and on coughing
pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)
Measured: 24 hours
opioid side-effects
observation of side effects and record incidence as nausea, vomiting and itching
Measured: 24 hours
patient satisfaction
scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Adel El sherif,MD, Assiut University
- Investigators
- fatma el sherif, M.D, Principal investigator, south Egypt cancer institute - assuit universityAhmad M Abd El-Rahman, M.D, Study director, Lecturer of anesthesia, icu, and pain management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03002909
- Sponsor's protocol ID
- 369
- Status last verified
- Dec 2017
- First submitted
- 19 Dec 2016
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
PubMed 30829734
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy
- ClinicalTrials.gov ID
- NCT03002909
- Acronym / sponsor ID
- 369
- Conditions
- Abdominal Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- May 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 26 Dec 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.
the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| epidural group | Active comparator | Device: epidural catheteran epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. . |
| preperitoneal group | Active comparator | Device: preperitoneal catheterpreperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA I-III patients
- aged 18-60 yr
- undergo open abdominal cancer surgery
Key exclusion criteria (3 listed)
- general contraindications for epidural analgesia,
- recent history (8 weeks) of, chemotherapy or radiation,
- chronic opioid use
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 |
|---|---|---|
| epidural catheterAlso: PEA block | Device | epidural group |
| preperitoneal catheterAlso: preperitoneal infusion | Device | preperitoneal group |
Primary outcome
changes in the level of inflammatory cytokines in pg /ml
Time frame: 24 hours
Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines
3 secondary outcomes
Visual Analog Scale at rest and on coughing
Time frame: 24 hours
opioid side-effects
Time frame: 24 hours
patient satisfaction
Time frame: 24 hours
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 9 Oct 2018.
- Derived from this study: PubMed 30829734Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
- 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.
fatma el sherif, M.D principal investigator
south Egypt cancer institute - assuit university
Ahmad M Abd El-Rahman, M.D study director
Lecturer of anesthesia, icu, and pain management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing epidural catheter and preperitoneal catheter in people with Abdominal Neoplasms, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 3 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 9 Oct 2018. 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 Egypt. 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?
changes in the level of inflammatory cytokines in pg /ml (time frame: 24 hours). 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 NCT03002909, which also lists 1 linked publication.
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 9 Oct 2018.