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Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients

Primary Purpose

Abdominal Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
levo-bupivacaine infusion via Thoracic epidural catheter
levo-bupivacaine infusion via preperitoneal catheter
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 :

A) Cerebral aneurysm, Recent brain surgery, recent concussion, recent eye surgery& Significant glaucoma.

B) Recent sinus surgery or middle ear surgery or infection. C) Pneumothorax, Significant aortic aneurysm, Recent thoracic surgery or Recent abdominal surgery .

D) Systemic hypotension or severe hypertension (eg, >200/120 mmHg), Significant atrial/ ventricular arrhythmia , Noncompensated heart failure , Recent myocardial infarction or pulmonary embolus.

E) 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)].

Sites / Locations

  • South Egypt Cancer Inistitute
  • South Egypt Cancer Inistitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

levo-bupivacaine continuous epidural infusion [CEI])

Levo-bupivacaine continuous preperitoneal infusion [CPI]),

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in Cardiac enzymes levels
Troponin I and plasma BNP levels will be 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

Full Information

First Posted
October 16, 2019
Last Updated
September 15, 2022
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04152564
Brief Title
Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 29, 2018 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
September 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Egypt Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
levo-bupivacaine continuous epidural infusion [CEI])
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Levo-bupivacaine continuous preperitoneal infusion [CPI]),
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
levo-bupivacaine infusion via Thoracic epidural catheter
Other Intervention Name(s)
TEA
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
levo-bupivacaine infusion via preperitoneal catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
change in Respiratory mechanics
Description
Forced Vital Capacity (FVC) &Forced Expiratory Volume in one second (FEV1) will be assessed preoperativly and at Day 1 & Day2 postoperative.
Time Frame
preoperative-Day 1 & Day2 postoperative
Secondary Outcome Measure Information:
Title
change in Cardiac enzymes levels
Description
Troponin I and plasma BNP levels will be measured preoperatively and postoperative day 1 and day 2.
Time Frame
preoperatively and postoperative Day 1 and Day 2.
Title
change in Visual analogue pain score
Description
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
Time Frame
immediately postoperative then at 2 hours, 4hours ,6hours ,12hours, 24hours ,36hours &48 hours after surgery
Other Pre-specified Outcome Measures:
Title
Morphine titration and dosage required in the post-anesthesia care unit (PACU).
Description
IV PCA Total morphine consumption during first 48 hours postoperatively.
Time Frame
first 48 hours postoperatively.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 : A) Cerebral aneurysm, Recent brain surgery, recent concussion, recent eye surgery& Significant glaucoma. B) Recent sinus surgery or middle ear surgery or infection. C) Pneumothorax, Significant aortic aneurysm, Recent thoracic surgery or Recent abdominal surgery . D) Systemic hypotension or severe hypertension (eg, >200/120 mmHg), Significant atrial/ ventricular arrhythmia , Noncompensated heart failure , Recent myocardial infarction or pulmonary embolus. E) 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)].
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
samy AA erfan, professor
Organizational Affiliation
dean of SECI
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer Inistitute
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Facility Name
South Egypt Cancer Inistitute
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients

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