Clinical trial NCT03460561: Peri-operative Rectus Sheath Block Versus TEA Abdominal Surgeries
Official title: Peri-operative Rectus Sheath Fentanyl-Levo Bupivacaine Infusion Versus Thoracic Epidural Fentanyl-Levo Bupivacaine Infusion in Patients Undergoing Major Abdominal Cancer Surgeries With Medline Incision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Cancer
Keywords: TEA
Rectus sheath block
Major abdominal cancer surgery
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Thoracic epidural analgesia (TEA) can be considered the gold standard for postoperative analgesia in major abdominal surgeries, as proved by a lot of number of systematic reviews and meta-analyses have demonstrated that TEA was associated with superior postoperative analgesia, better patients' outcomes, reducing (systemic opiate requirements, ileus and pulmonary complications).

The rectus sheath block (RSB) is effective for the surgeries that necessitated midline abdominal incisions as local anesthetics instillation will be within the posterior rectus sheath bilaterally providing intense analgesia for the middle anterior wall from the xiphoid process to the symphysis pubis in adults.

Detailed description: The aim of the study was to assess the efficacy and safety of intra and post operative ultrasound-guided RSB versus intra and post operative TEA and to investigate role of Fentanyl as an adjuvant in both RSB and TEA, in patients undergoing elective major abdominal surgery with midline abdominal incisions.

Pre operative medications in the form of oral ranitidine tablet, 50 mg and lorazepam tablet, 3 mg on the night of surgery were given to all patients.

All patients were taught- The day before surgery- how to evaluate their own pain intensity using the visual analog scale (VAS), scored from 0 to 10 (where 0=no pain and 10= worst pain imaginable) and how to use the patient controlled analgesia (PCA) device (Abbott Laboratories, North Chicago, IL, USA).

Patients were randomly assigned into two groups, 50 patients each, by using opaque sealed envelopes containing a computer generated randomization schedule; the opaque envelopes were sequentially numbered and were opened before application of anesthetic plan.

TEA group (No. =50); where patients received TEA in conjunction with GA, intraoperative analgesia was started before skin incision by epidural bolus dose of 0.1 ml ∕ kg of 0.125% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml. Postoperative analgesia was provided through Patient controlled epidural analgesia (PCEA) for 48 hours postoperative, by continuous infusion of a mixture of (0.0625% levo-bupivacaine ∕ fentanyl 2 µg ∕ ml) in a dose of of 0.1 ml ∕ kg, and bolus dose of 3 ml, lockout interval of 20 minutes).

RSB group (No. =50); combined general plus US guided rectus sheath block (group-RSB): where 20 mL of (0.25% levo-bupivacaine + fentanyl 30 µg) in saline were injected into the rectus sheath plane on either side under direct US visualization 15 minutes before skin incision.

And before closure of abdominal wall, bilateral surgically placed catheters in rectus sheath plane for post operative analgesia for 48 hours.

Postoperative analgesia was as following; injection of 20 mL of (0.125% levo-bupivicaine +Fentanyl 30 μg) every 12 hours in to each catheter, A postoperative rescue analgesia with intravenous Fentanyl per a titration protocol (Fentanyl 30 μg IV as a bolus dose that could be repeated every 10 minute) was employed if visual analog pain scale (VAS) ≥4.

Eligibility criteria: Inclusion Criteria:

* 100 adult patients, classified as American Society of Anesthesiologists (ASA) grade II and III, scheduled for elective major abdominal cancer surgery were consecutively enrolled.

Exclusion Criteria:

* We excluded from the study; patients who refused the study, Patients with coagulopathy, active neurological disease, cutaneous disorders at the epidural insertion site, and who were allergic to the studied medications.

Primary outcomes:
measure: assessing a change in VAS score with cough
timeFrame: at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary outcomes:
measure: assessing a change of MAP
timeFrame: at baseline , 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
Study officials:
affiliation: Principal Investigator
name: Alaa A. Elzohry, MD
role: PRINCIPAL_INVESTIGATOR
References: