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

NCT04152564 | Completed

• 1 other identifier: 440
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  preoperative-Day 1 & Day2 postoperative

Secondary Outcomes (2)

• change in Cardiac enzymes levels

  preoperatively and postoperative Day 1 and Day 2.

• change in Visual analogue pain score

  immediately postoperative then at 2 hours, 4hours ,6hours ,12hours, 24hours ,36hours &48 hours after surgery

Other Outcomes (1)

• Morphine titration and dosage required in the post-anesthesia care unit (PACU).

  first 48 hours postoperatively.

Study Arms (2)

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.

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.

Procedure: levo-bupivacaine infusion via preperitoneal catheter

Interventions

levo-bupivacaine infusion via Thoracic epidural catheter PROCEDURE

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

Also known as: TEA

levo-bupivacaine continuous epidural infusion [CEI])

levo-bupivacaine infusion via preperitoneal catheter PROCEDURE

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

Levo-bupivacaine continuous preperitoneal infusion [CPI]),

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[Inability to follow directions (eg, confusion, dementia, young age, language barrier)\].

Sponsors & Collaborators

• South Egypt Cancer Institute: lead

Study Sites (2)

South Egypt Cancer Inistitute

Asyut, 171516, Egypt

Location

South Egypt Cancer Inistitute

Asyut, 71111, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• samy AA erfan, professor

  dean of SECI

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: November 5, 2019
• Study Start: October 29, 2018
• Primary Completion: July 30, 2022
• Study Completion: September 8, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)