Abdominal Cancer SurgeryNCT05121987
Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery
A study testing Erector Spinae Plane block and Continuous Wound Infusion in people with Abdominal Cancer Surgery, run by South Egypt Cancer Institute.
Trial summary
We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Abdominal Cancer Surgery
- What is being tested?
- Erector Spinae Plane block and Continuous Wound Infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Apr 2023
- 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 physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2
Who cannot join
- ASA physical status ≥III, pregnancy, body mass index >30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.
About this study
Official title: Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery: a Randomized Double-blind Study
We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.
- Conditions
- Abdominal Cancer Surgery
- Being tested
- Erector Spinae Plane block, Continuous Wound Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane blockProcedure or surgery
An ultrasound linear probe is going to be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. . Local infiltration with 2% of lignocaine at the site of needle insertion is going to be administered. Using in plane approach an 18 G Tuohy needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 5 ml of normal saline.
Continuous Wound InfusionProcedure or surgery
Towards the end of surgery, a multiholed 15-cm Anesthesia catheter will be placed in the preperitoneal space (the subfascial space between the peritoneum and posterior fascia) under direct vision and to be tunneled via the rectus sheath to the skin, rolled out and exiting laterally and stabilized with an adhesive tape on skin.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Active comparator | Not described Receives: Procedure: Erector Spinae Plane block |
| Continuous wound infusion | Active comparator | Not described Receives: Procedure: Continuous Wound Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Morphine consumption
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Cancer 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
- Prevention
- 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
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abd El-Hameed Osman, South Egypt Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05121987
- Sponsor's protocol ID
- 563
- Status last verified
- Nov 2021
- First submitted
- 4 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT05121987
- Acronym / sponsor ID
- 563
- Conditions
- Abdominal Cancer Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Apr 2023 (estimated)
- First posted
- 16 Nov 2021 (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.
We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Active comparator | Procedure: Erector Spinae Plane block |
| Continuous wound infusion | Active comparator | Procedure: Continuous Wound 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 physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2
Key exclusion criteria (1 listed)
- ASA physical status ≥III, pregnancy, body mass index >30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.
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 |
|---|---|---|
| Erector Spinae Plane blockAn ultrasound linear probe is going to be placed in a longitudinal orientation 3 cm lateral to the T6 spinous process corresponding to the T5 transverse process. . Local infiltration with 2% of lignocaine at the site of needle insertion is going to be administered. Using in plane approach an 18 G Tuohy needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle, as evidenced by visible hydro-dissection below the muscle plane, and on injection of 5 ml of normal saline. | Procedure or surgery | Erector spinae plane block |
| Continuous Wound InfusionTowards the end of surgery, a multiholed 15-cm Anesthesia catheter will be placed in the preperitoneal space (the subfascial space between the peritoneum and posterior fascia) under direct vision and to be tunneled via the rectus sheath to the skin, rolled out and exiting laterally and stabilized with an adhesive tape on skin. | Procedure or surgery | Continuous wound infusion |
Primary outcome
Total Morphine consumption
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane block and Continuous Wound Infusion in people with Abdominal Cancer Surgery, run by South Egypt Cancer Institute.
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 1 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Total Morphine consumption (time frame: 48 hours). 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 16 Nov 2021.