Lateral, Major Abdominal Cancer Surgery, Postoperative Analgesia, Subcostal, Thoracic Epidural Analgesia, Transversus Abdominis Plane Block
Conditions
Brief summary
This study aims to evaluate the safety and efficacy of combined subcostal and lateral transversus abdominis plane (TAP) for postoperative analgesia versus thoracic epidural anesthesia (TEA) in patients undergoing major abdominal cancer surgery.
Detailed description
Postoperative pain is treated using a variety of techniques. It is possible to deliver opioids intravenously, neuraxially, or both. Thoracic epidural anesthesia (TEA) has long been considered the benchmark for analgesia in major abdominal operations due to its consistent efficacy in pain control and additional benefits such as reduced ileus and improved pulmonary function. Transversus abdominis plane (TAP) blocks can be a critical component of postoperative pain management, and they play a crucial role in Enhanced Recovery After Surgery (ERAS) protocols, as they significantly affect recovery and patient well-being.
Interventions
OTHERSubcostal and lateral transversus abdominis plane block
Patients will receive an ultrasound-guided combined subcostal and lateral transversus abdominis plane block.
Patients will receive an ultrasound-guided thoracic epidural anesthesia.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I-III. * Scheduled for major abdominal surgeries including: (e.g., gastrectomy, colectomy, hepatectomy, cystectomy, total abdominal hysterectomy, Nephrectomy, pancreatectomy).
Exclusion criteria
* Intraoperative hemodynamic instability. * History or evidence of coagulopathy. * Infection or abdominal wall masses at injection site. * Morbid obesity. * Other Medical conditions including mental illness or substance abuse. * Known allergy to local anesthetics. * Chronic opioid use or chronic pain conditions. * Pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | 24 hours postoperatively | Rescue analgesia of morphine will be given as 3 mg bolus if the Visual Analogue Scale (VAS) \> 3 to be repeated after 30 min if pain persists until the VAS \< 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to the 1st rescue analgesia | 24 hours postoperatively | Time to the first request for the rescue analgesia (time from the end of surgery to first dose of morphine administrated). |
| Mean arterial pressure | Till the end of surgery (Up to 2 hours) | Mean arterial pressure will be recorded before skin incision, one minute after skin incision and then recorded regularly every 10 minutes. |
| Heart rate | Till the end of surgery (Up to 2 hours) | Heart rate will be recorded before skin incision, one minute after skin incision and then recorded regularly every 10 minutes. |
| Degree of pain | 24 hours postoperatively | Each patient will be instructed about postoperative pain assessment with the Visual Analogue Scale (VAS). VAS (0 represents no pain while 10 represents the worst pain imaginable). VAS will be assessed at 0, 4, 6, 8, 12, and 24 h postoperatively. |
| Incidence of adverse events | 24 hours postoperatively | Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication. |
Countries
Egypt
Contacts
Primary ContactBahaa G Saad, MD
Outcome results
None listed