Abdominal CancerNCT04152564
Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients
A study testing levo-bupivacaine infusion via Thoracic epidural catheter and levo-bupivacaine infusion via preperitoneal catheter in people with Abdominal Cancer, run by South Egypt Cancer Institute at 2 sites in Egypt.
Trial summary
60 Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, First group (Control group ,Group of continous epidural infusion [CEI]), where patients will receive continuous epidural infusion of L-bupivacaine 0.125 % at a rate of .1 ml/kg/h during the… 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?
- levo-bupivacaine infusion via Thoracic epidural catheter and levo-bupivacaine infusion via preperitoneal catheter
- 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
- 2 sitesEgypt
- Study dates
- 29 Oct 2018to 8 Sep 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients subjected to major upper abdominal cancer surgery.
- The enrolled age will be from 18 years to 70 years
- ASA, I-III and NYHA, I-III.
Who cannot join
- ASA physical status and NYHA >III,
- pregnant women,
- body mass index >40 kg/m2,
- preoperative opioid consumption,
- Contraindications or patient's refusal of epidural analgesia, and inability to use a PCA device.
- Contraindications of use of spirometry device :
Show all 10Show fewer
- Cerebral aneurysm, Recent brain surgery, recent concussion, recent eye surgery\& Significant glaucoma.
- Recent sinus surgery or middle ear surgery or infection. C) Pneumothorax, Significant aortic aneurysm, Recent thoracic surgery or Recent abdominal surgery .
- Systemic hypotension or severe hypertension (eg, >200/120 mmHg), Significant atrial/ ventricular arrhythmia , Noncompensated heart failure , Recent myocardial infarction or pulmonary embolus.
- History of syncope related to forced exhalation/cough. F) Active tuberculosis , Hemoptysis or oral bleeding . 7-Uncooperative patients regarding use of spirometry [Inability to follow directions (eg, confusion, dementia, young age, language barrier)].
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
South Egypt Cancer Inistitute
Asyut, 171516
South Egypt Cancer Inistitute
Asyut, 71111
About this study
Official title: The Cardio-pulmonary and Analgesic Effects of Pre-peritoneal Infusion VS Epidural Infusion of Levo - Bupivacaine on Patients Undergoing Major Upper Abdominal Cancer Surgery
60 Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, First group (Control group ,Group of continous epidural infusion [CEI]), where patients will receive continuous epidural infusion of L-bupivacaine 0.125 % at a rate of .1 ml/kg/h during the first 48 hours after surgery. Second group (Group of continous preperitoneal infusion [CPI]), where patients will receive continuous pre-peritoneal wound infusion with L-bupivacaine 0.25% at 10 ml/h during the first 48 hours after surgery.
Read the detailed description
All patients will receive IV morphine when needed for a period of 48 hours with a PCA device programmed to deliver 1 mg/dose with a 10-minute lockout time without background infusion.
CEI group The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion. Proper placement of the catheter was verified through an aspiration test and a test dose (2 ml) of lidocaine 2%. At the end of surgery, a 14 ml bolus of L-bupivacaine 0.125 will be administered through the catheter and then a continuous rate of .1 ml/kg/h infusion of L-bupivacaine 0.125 will be delivered.
CPI group At the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing. Thereafter, a 20 ml bolus of L-bupivacaine 0.25% will be administered through the catheter and then a continuous fixed-rate infusion of L-bupivacaine 0.25% will be delivered.
Outcome Measures The primary outcome will be the pulmonary effects including
. Respiratory mechanics: Forced Vital Capacity (FVC) \&Forced Expiratory Volume in one second (FEV1) will be assessed preoperatively and at 12h, 24h and 48 hours postoperatively.
The Secondary outcome of the study will include the following:
- Cardiac enzymes: Troponin I and plasma BNP levels will be measured preoperatively and postoperative day 1 and day 2.
- Intensity of pain at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score immediately postoperative then at 2, 4 ,6 ,12, 24 ,36 \&48 hours after surgery.
- Hemodynamic variables including (systolic and diastolic BP, heart rate, oxygen saturation \& respiratory rate) measured preoperatively (baseline measurement) then immediately postoperative and at 2, 4 ,6 ,12, 24 ,36 \&48 hours after surgery.
- Blood gases will be drawn preoperatively and at 12 hour interval in the PACU for assessment of Oxygen tension (PO2) \& Co2 tension (PCO2).
- Morphine titration and dosage required in the post-anesthesia care unit (PACU).
- IV PCA Total morphine consumption during first 48 hours postoperatively.
- Time of return of intestinal sounds.
- CVP will be measured preoperatively and at post anaesthesia care unit for crude assessment of cardiac function
- Quality of night sleep assessed at 8:00 am on postoperative days 1 and 2 using a verbal numerical scale (VNS) ranging from 0 (poor quality) to 10 (excellent quality).
- Patient satisfaction with the quality of postoperative analgesia 48 hours after the end of surgery, assessed on a 5-point scale (completely dissatisfied, dissatisfied, not satisfied nor dissatisified, satisfied or completely satisfied [34].
- side effects, including hemodynamic variables (hypotension \& bradycardia), supine hypotension ,shivering ,bladder distension and PONV.
- Complications of Thoracic epidural as (Inadvertent intrathecal injection, Spinal hematoma, Spinal abscess, superficial cellulites, PDPH, Nerve injury \&Back pain) will be assessed and managed
- Conditions
- Abdominal Cancer
- Being tested
- levo-bupivacaine infusion via Thoracic epidural catheter, levo-bupivacaine infusion via preperitoneal catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levo-bupivacaine infusion via Thoracic epidural catheterProcedure or surgery
Also called TEA
The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion
levo-bupivacaine infusion via preperitoneal catheterProcedure or surgery
At the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing
| Study group | Role | What they receive |
|---|---|---|
| levo-bupivacaine continuous epidural infusion [CEI]) | Active comparator | The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion. Proper placement of the catheter was verified through an aspiration test and a test dose (2 ml) of lidocaine 2%. At the end of surgery, a 14 ml bolus of L-bupivacaine 0.125 will be administered through the catheter and then a continuous rate of .1 ml/kg/h infusion of L-bupivacaine 0.125 will be delivered. Receives: Procedure: levo-bupivacaine infusion via Thoracic epidural catheter |
| Levo-bupivacaine continuous preperitoneal infusion [CPI]), | Active comparator | At the end of surgery and after the closure of the peritoneal layer, the preperitoneal catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing. Thereafter, a 20 ml bolus of L-bupivacaine 0.25% will be administered through the catheter and then a continuous fixed-rate infusion of L-bupivacaine 0.25% will be delivered. Receives: Procedure: levo-bupivacaine infusion via preperitoneal catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Respiratory mechanics
Forced Vital Capacity (FVC) \&Forced Expiratory Volume in one second (FEV1) will be assessed preoperativly and at Day 1 \& Day2 postoperative.
Measured: preoperative-Day 1 & Day2 postoperative
Secondary outcomes (2)
change in Cardiac enzymes levels
Troponin I and plasma BNP levels will be measured preoperatively and postoperative day 1 and day 2.
Measured: preoperatively and postoperative Day 1 and Day 2.
change in Visual analogue pain score
Intensity of pain at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score with 11points where 0 means no pain,10 means sever pain
Measured: immediately postoperative then at 2 hours, 4hours ,6hours ,12hours, 24hours ,36hours &48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start29 Oct 2018
- Primary completion30 Jul 2022
- Study completion8 Sep 2022
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Egypt Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Farghaly Abd El hamid Ahmed, South Egypt Cancer Institute
- Investigators
- samy AA erfan, professor, Study director, dean of SECI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152564
- Sponsor's protocol ID
- 440
- Status last verified
- Sep 2022
- First submitted
- 16 Oct 2019
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cardio-pulmonary and Analgesic Effects of Pre-peritoneal Infusion VS Epidural Infusion of Levo - Bupivacaine on Patients Undergoing Major Upper Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04152564
- Acronym / sponsor ID
- 440
- Conditions
- Abdominal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- South Egypt Cancer InstituteUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 5 Nov 2019 (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.
60 Patients will be randomly assigned using computer generated randomization program (http://www.randomizer.org) into two groups, First group (Control group ,Group of continous epidural infusion [CEI]), where patients will receive continuous epidural infusion of L-bupivacaine 0.125 % at a rate of .1 ml/kg/h during the first 48 hours after surgery. Second group (Group of continous preperitoneal infusion [CPI]), where patients will receive continuous pre-peritoneal wound infusion with L-bupivacaine 0.25% at 10 ml/h during the first 48 hours after surgery.
Detailed description
All patients will receive IV morphine when needed for a period of 48 hours with a PCA device programmed to deliver 1 mg/dose with a 10-minute lockout time without background infusion.
CEI group The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion. Proper placement of the catheter was verified through an aspiration test and a test dose (2 ml) of lidocaine 2%. At the end of surgery, a 14 ml bolus of L-bupivacaine 0.125 will be administered through the catheter and then a continuous rate of .1 ml/kg/h infusion of L-bupivacaine 0.125 will be delivered.
CPI group At the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing. Thereafter, a 20 ml bolus of L-bupivacaine 0.25% will be administered through the catheter and then a continuous fixed-rate infusion of L-bupivacaine 0.25% will be delivered.
Outcome Measures The primary outcome will be the pulmonary effects including
. Respiratory mechanics: Forced Vital Capacity (FVC) \&Forced Expiratory Volume in one second (FEV1) will be assessed preoperatively and at 12h, 24h and 48 hours postoperatively.
The Secondary outcome of the study will include the following:
- Cardiac enzymes: Troponin I and plasma BNP levels will be measured preoperatively and postoperative day 1 and day 2.
- Intensity of pain at rest and during pain-provoking movements (deep breathing, coughing, mobilization) measured by VAS pain score immediately postoperative then at 2, 4 ,6 ,12, 24 ,36 \&48 hours after surgery.
- Hemodynamic variables including (systolic and diastolic BP, heart rate, oxygen saturation \& respiratory rate) measured preoperatively (baseline measurement) then immediately postoperative and at 2, 4 ,6 ,12, 24 ,36 \&48 hours after surgery.
- Blood gases will be drawn preoperatively and at 12 hour interval in the PACU for assessment of Oxygen tension (PO2) \& Co2 tension (PCO2).
- Morphine titration and dosage required in the post-anesthesia care unit (PACU).
- IV PCA Total morphine consumption during first 48 hours postoperatively.
- Time of return of intestinal sounds.
- CVP will be measured preoperatively and at post anaesthesia care unit for crude assessment of cardiac function
- Quality of night sleep assessed at 8:00 am on postoperative days 1 and 2 using a verbal numerical scale (VNS) ranging from 0 (poor quality) to 10 (excellent quality).
- Patient satisfaction with the quality of postoperative analgesia 48 hours after the end of surgery, assessed on a 5-point scale (completely dissatisfied, dissatisfied, not satisfied nor dissatisified, satisfied or completely satisfied [34].
- side effects, including hemodynamic variables (hypotension \& bradycardia), supine hypotension ,shivering ,bladder distension and PONV.
- Complications of Thoracic epidural as (Inadvertent intrathecal injection, Spinal hematoma, Spinal abscess, superficial cellulites, PDPH, Nerve injury \&Back pain) will be assessed and managed
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| levo-bupivacaine continuous epidural infusion [CEI]) | Active comparator | Procedure: levo-bupivacaine infusion via Thoracic epidural catheterThe epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion. Proper placement of the catheter was verified through an aspiration test and a test dose (2 ml) of lidocaine 2%. At the end of surgery, a 14 ml bolus of L-bupivacaine 0.125 will be administered through the catheter and then a continuous rate of .1 ml/kg/h infusion of L-bupivacaine 0.125 will be delivered. |
| Levo-bupivacaine continuous preperitoneal infusion [CPI]), | Active comparator | Procedure: levo-bupivacaine infusion via preperitoneal catheterAt the end of surgery and after the closure of the peritoneal layer, the preperitoneal catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing. Thereafter, a 20 ml bolus of L-bupivacaine 0.25% will be administered through the catheter and then a continuous fixed-rate infusion of L-bupivacaine 0.25% will be delivered. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients subjected to major upper abdominal cancer surgery.
- The enrolled age will be from 18 years to 70 years
- ASA, I-III and NYHA, I-III.
Key exclusion criteria (10 listed)
- ASA physical status and NYHA >III,
- pregnant women,
- body mass index >40 kg/m2,
- preoperative opioid consumption,
- Contraindications or patient's refusal of epidural analgesia, and inability to use a PCA device.
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 |
|---|---|---|
| levo-bupivacaine infusion via Thoracic epidural catheterAlso: TEAThe epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion | Procedure or surgery | levo-bupivacaine continuous epidural infusion [CEI]) |
| levo-bupivacaine infusion via preperitoneal catheterAt the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing | Procedure or surgery | Levo-bupivacaine continuous preperitoneal infusion [CPI]), |
Primary outcome
change in Respiratory mechanics
Time frame: preoperative-Day 1 & Day2 postoperative
Forced Vital Capacity (FVC) \&Forced Expiratory Volume in one second (FEV1) will be assessed preoperativly and at Day 1 \& Day2 postoperative.
2 secondary outcomes
change in Cardiac enzymes levels
Time frame: preoperatively and postoperative Day 1 and Day 2.
change in Visual analogue pain score
Time frame: immediately postoperative then at 2 hours, 4hours ,6hours ,12hours, 24hours ,36hours &48 hours after 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 16 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Abdominal Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
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.
samy AA erfan, professor study director
dean of SECI
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levo-bupivacaine infusion via Thoracic epidural catheter and levo-bupivacaine infusion via preperitoneal catheter in people with Abdominal Cancer, run by South Egypt Cancer Institute at 2 sites 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 10 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 16 Sep 2022. 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 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?
change in Respiratory mechanics (time frame: preoperative-Day 1 & Day2 postoperative). 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 Sep 2022.