Clinical trial · Interventional
Cardio-pulmonary and Analgesic Effects of Pre-peritoneal VS Epidural Infusion of L-bupivacaine on Abd. Cancer Patients
The Cardio-pulmonary and Analgesic Effects of Pre-peritoneal Infusion VS Epidural Infusion of Levo - Bupivacaine on Patients Undergoing Major Upper Abdominal Cancer Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| levo-bupivacaine infusion via preperitoneal catheter | Procedure | — | UNRESOLVED |
| levo-bupivacaine infusion via Thoracic epidural catheter | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- levo-bupivacaine continuous epidural infusion [CEI])
- 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.
- interventionNames
- Procedure: levo-bupivacaine infusion via Thoracic epidural catheter
- type
- ACTIVE_COMPARATOR
- label
- Levo-bupivacaine continuous preperitoneal infusion [CPI]),
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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 \[Inability to follow directions (eg, confusion, dementia, young age, language barrier)\].
References
Publications (0)
Data not yet available