Abdominal CancerPhase 3NCT03460561
Peri-operative Rectus Sheath Block Versus TEA Abdominal Surgeries
A Phase 3 study testing Thoracic epidural block (TEA) and Rectus sheath block (RSB) in people with Abdominal Cancer, run by South Egypt Cancer Institute at 1 site in Egypt.
Trial summary
Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews and meta-analyses have demonstrated that TEA was associated with superior postoperative analgesia, better patients' outcomes, reducing… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Thoracic epidural block (TEA) and Rectus sheath block (RSB)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2016to 20 Feb 2018
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 100 adult patients, classified as American Society of Anesthesiologists (ASA) grade II and III, scheduled for elective major abdominal cancer surgery were consecutively enrolled.
Who cannot join
- We excluded from the study; patients who refused the study, Patients with coagulopathy, active neurological disease, cutaneous disorders at the epidural insertion site, and who were allergic to the studied medications.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Asyut, 0020
About this study
Official title: Peri-operative Rectus Sheath Fentanyl-Levo Bupivacaine Infusion Versus Thoracic Epidural Fentanyl-Levo Bupivacaine Infusion in Patients Undergoing Major Abdominal Cancer Surgeries With Medline Incision
Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews and meta-analyses have demonstrated that TEA was associated with superior postoperative analgesia, better patients' outcomes, reducing (systemic opiate requirements, ileus and pulmonary complications).
The rectus sheath block (RSB) is effective for the surgeries that necessitated midline abdominal incisions as local anesthetics instillation will be within the posterior rectus sheath bilaterally providing intense analgesia for the middle anterior wall from the xiphoid process to the symphysis pubis in adults.
Read the detailed description
The aim of the study was to assess the efficacy and safety of intra and post operative ultrasound-guided RSB versus intra and post operative TEA and to investigate role of Fentanyl as an adjuvant in both RSB and TEA, in patients undergoing elective major abdominal surgery with midline abdominal incisions.
Pre operative medications in the form of oral ranitidine tablet, 50 mg and lorazepam tablet, 3 mg on the night of surgery were given to all patients.
All patients were taught- The day before surgery- how to evaluate their own pain intensity using the visual analog scale (VAS), scored from 0 to 10 (where 0=no pain and 10= worst pain imaginable) and how to use the patient controlled analgesia (PCA) device (Abbott Laboratories, North Chicago, IL, USA).
Patients were randomly assigned into two groups, 50 patients each, by using opaque sealed envelopes containing a computer generated randomization schedule; the opaque envelopes were sequentially numbered and were opened before application of anesthetic plan.
TEA group (No. =50); where patients received TEA in conjunction with GA, intraoperative analgesia was started before skin incision by epidural bolus dose of 0.1 ml ∕ kg of 0.125% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml. Postoperative analgesia was provided through Patient controlled epidural analgesia (PCEA) for 48 hours postoperative, by continuous infusion of a mixture of (0.0625% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml) in a dose of of 0.1 ml ∕ kg, and bolus dose of 3 ml, lockout interval of 20 minutes).
RSB group (No. =50); combined general plus US guided rectus sheath block (group-RSB): where 20 mL of (0.25% levo-bupivacaine + fentanyl 30 µg) in saline were injected into the rectus sheath plane on either side under direct US visualization 15 minutes before skin incision.
And before closure of abdominal wall, bilateral surgically placed catheters in rectus sheath plane for post operative analgesia for 48 hours.
Postoperative analgesia was as following; injection of 20 mL of (0.125% levo-bupivicaine +Fentanyl 30 μg) every 12 hours in to each catheter, A postoperative rescue analgesia with intravenous Fentanyl per a titration protocol (Fentanyl 30 μg IV as a bolus dose that could be repeated every 10 minute) was employed if visual analog pain scale (VAS) ≥4.
- Conditions
- Abdominal Cancer
- Being tested
- Thoracic epidural block (TEA), Rectus sheath block (RSB)
- Keywords
- TEA, Rectus sheath block, Major abdominal cancer surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural block (TEA)Procedure or surgery
Also called Thoracic epidural analgesia
Under complete aseptic precautions and before induction of GA, thoracic epidural catheter was inserted using a 17 gauge, Tuohy epidural needle by a midline approach. T9-T10 interspace was chosen for the injection after skin infiltration by 5 mL of lidocaine 1%. The epidural space was identified by the loss of resistance technique then the catheter was introduced 2 cm into the epidural space, and epidural test dose of 3 mL of lidocaine 2% with 1:200,000 adrenaline was injected to exclude vascular or subarachnoid position.
Rectus sheath block (RSB)Procedure or surgery
Under aseptic technique, the rectus muscle was imaged with the ultrasound probe, A broadband (5-12 MHz) linear array probe of Sonosite ™ 3000 ultrasound (FUJIFILM, Sonosite EDGE II -UAS) in a transverse orientation at or immediately above the level of the umbilicus, with an imaging depth of 4-6 cm.
Inserting the needle: An 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique in an angle of 45 degrees to the skin. (posterior rectus sheath and fascia transversalis). Under direct vision, the needle tip was advanced to the desired position where 20 mL of (levo-bupivacaine 0.25% Fentanyl 30 μg) were injected causing hydro dissection of the rectus muscle away from the posterior rectus sheath. The technique is repeated on the opposite side.
| Study group | Role | What they receive |
|---|---|---|
| TEA group | Active comparator | peri operative thoracic epidural block (TEA) via fentanyl-levo bupivacaine infusion. Receives: Procedure: Thoracic epidural block (TEA) |
| RSB group | Active comparator | peri operative rectus sheath block (RSB) via fentanyl-levo bupivacaine infusion. Receives: Procedure: Rectus sheath block (RSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessing a change in VAS score with cough
assessing a change in Pain severity by VAS score with cough (0-10) 0=no pain 10=worst pain ever
Measured: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary outcomes (1)
assessing a change of MAP
assessing a change in Mean arterial pressure from baseline reading
Measured: at baseline , 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study start1 Aug 2016
- Primary completion20 Feb 2018
- Study completion20 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Ali M. Elzohry, South Egypt Cancer Institute
- Investigators
- Alaa A. Elzohry, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460561
- Sponsor's protocol ID
- South Egypt Cancer Institute
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-operative Rectus Sheath Fentanyl-Levo Bupivacaine Infusion Versus Thoracic Epidural Fentanyl-Levo Bupivacaine Infusion in Patients Undergoing Major Abdominal Cancer Surgeries With Medline Incision
- ClinicalTrials.gov ID
- NCT03460561
- Acronym / sponsor ID
- South Egypt Cancer Institute
- Conditions
- Abdominal Cancer
- Keywords
- TEA, Rectus sheath block, Major abdominal cancer surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 20 Feb 2018 (actual)
- Study completion
- 20 Feb 2018 (actual)
- First posted
- 9 Mar 2018 (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.
Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews and meta-analyses have demonstrated that TEA was associated with superior postoperative analgesia, better patients' outcomes, reducing (systemic opiate requirements, ileus and pulmonary complications).
The rectus sheath block (RSB) is effective for the surgeries that necessitated midline abdominal incisions as local anesthetics instillation will be within the posterior rectus sheath bilaterally providing intense analgesia for the middle anterior wall from the xiphoid process to the symphysis pubis in adults.
Detailed description
The aim of the study was to assess the efficacy and safety of intra and post operative ultrasound-guided RSB versus intra and post operative TEA and to investigate role of Fentanyl as an adjuvant in both RSB and TEA, in patients undergoing elective major abdominal surgery with midline abdominal incisions.
Pre operative medications in the form of oral ranitidine tablet, 50 mg and lorazepam tablet, 3 mg on the night of surgery were given to all patients.
All patients were taught- The day before surgery- how to evaluate their own pain intensity using the visual analog scale (VAS), scored from 0 to 10 (where 0=no pain and 10= worst pain imaginable) and how to use the patient controlled analgesia (PCA) device (Abbott Laboratories, North Chicago, IL, USA).
Patients were randomly assigned into two groups, 50 patients each, by using opaque sealed envelopes containing a computer generated randomization schedule; the opaque envelopes were sequentially numbered and were opened before application of anesthetic plan.
TEA group (No. =50); where patients received TEA in conjunction with GA, intraoperative analgesia was started before skin incision by epidural bolus dose of 0.1 ml ∕ kg of 0.125% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml. Postoperative analgesia was provided through Patient controlled epidural analgesia (PCEA) for 48 hours postoperative, by continuous infusion of a mixture of (0.0625% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml) in a dose of of 0.1 ml ∕ kg, and bolus dose of 3 ml, lockout interval of 20 minutes).
RSB group (No. =50); combined general plus US guided rectus sheath block (group-RSB): where 20 mL of (0.25% levo-bupivacaine + fentanyl 30 µg) in saline were injected into the rectus sheath plane on either side under direct US visualization 15 minutes before skin incision.
And before closure of abdominal wall, bilateral surgically placed catheters in rectus sheath plane for post operative analgesia for 48 hours.
Postoperative analgesia was as following; injection of 20 mL of (0.125% levo-bupivicaine +Fentanyl 30 μg) every 12 hours in to each catheter, A postoperative rescue analgesia with intravenous Fentanyl per a titration protocol (Fentanyl 30 μg IV as a bolus dose that could be repeated every 10 minute) was employed if visual analog pain scale (VAS) ≥4.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEA group | Active comparator | Procedure: Thoracic epidural block (TEA)peri operative thoracic epidural block (TEA) via fentanyl-levo bupivacaine infusion. |
| RSB group | Active comparator | Procedure: Rectus sheath block (RSB)peri operative rectus sheath block (RSB) via fentanyl-levo bupivacaine infusion. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 100 adult patients, classified as American Society of Anesthesiologists (ASA) grade II and III, scheduled for elective major abdominal cancer surgery were consecutively enrolled.
Key exclusion criteria (1 listed)
- We excluded from the study; patients who refused the study, Patients with coagulopathy, active neurological disease, cutaneous disorders at the epidural insertion site, and who were allergic to the studied medications.
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 |
|---|---|---|
| Thoracic epidural block (TEA)Also: Thoracic epidural analgesiaUnder complete aseptic precautions and before induction of GA, thoracic epidural catheter was inserted using a 17 gauge, Tuohy epidural needle by a midline approach. T9-T10 interspace was chosen for the injection after skin infiltration by 5 mL of lidocaine 1%. The epidural space was identified by the loss of resistance technique then the catheter was introduced 2 cm into the epidural space, and epidural test dose of 3 mL of lidocaine 2% with 1:200,000 adrenaline was injected to exclude vascular or subarachnoid position. | Procedure or surgery | TEA group |
| Rectus sheath block (RSB)Under aseptic technique, the rectus muscle was imaged with the ultrasound probe, A broadband (5-12 MHz) linear array probe of Sonosite ™ 3000 ultrasound (FUJIFILM, Sonosite EDGE II -UAS) in a transverse orientation at or immediately above the level of the umbilicus, with an imaging depth of 4-6 cm. Inserting the needle: An 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique in an angle of 45 degrees to the skin. (posterior rectus sheath and fascia transversalis). Under direct vision, the needle tip was advanced to the desired position where 20 mL of (levo-bupivacaine 0.25% Fentanyl 30 μg) were injected causing hydro dissection of the rectus muscle away from the posterior rectus sheath. The technique is repeated on the opposite side. | Procedure or surgery | RSB group |
Primary outcome
assessing a change in VAS score with cough
Time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
assessing a change in Pain severity by VAS score with cough (0-10) 0=no pain 10=worst pain ever
1 secondary outcome
assessing a change of MAP
Time frame: at baseline , 4, 8, 12, 18, 24, 36 and 48 hours post operative.
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 Mar 2018.
- 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.
Alaa A. Elzohry, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thoracic epidural block (TEA) and Rectus sheath block (RSB) in people with Abdominal Cancer, run by South Egypt Cancer Institute 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 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: finished, as of the sponsor's last update on 9 Mar 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
assessing a change in VAS score with cough (time frame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.). 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 9 Mar 2018.