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Peri-operative Rectus Sheath Block Versus TEA Abdominal Surgeries

Primary Purpose

Abdominal Cancer

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Thoracic epidural block (TEA)
Rectus sheath block (RSB)
Sponsored by
South Egypt Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Abdominal Cancer focused on measuring TEA, Rectus sheath block, Major abdominal cancer surgery

Eligibility Criteria

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

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.

Sites / Locations

  • South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

TEA group

RSB group

Arm Description

peri operative thoracic epidural block (TEA) via fentanyl-levo bupivacaine infusion.

peri operative rectus sheath block (RSB) via fentanyl-levo bupivacaine infusion.

Outcomes

Primary Outcome Measures

assessing a change in VAS score with cough
assessing a change in Pain severity by VAS score with cough (0-10) 0=no pain 10=worst pain ever

Secondary Outcome Measures

assessing a change of MAP
assessing a change in Mean arterial pressure from baseline reading

Full Information

First Posted
February 21, 2018
Last Updated
March 7, 2018
Sponsor
South Egypt Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03460561
Brief Title
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

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
February 20, 2018 (Actual)
Study Completion Date
February 20, 2018 (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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Cancer
Keywords
TEA, Rectus sheath block, Major abdominal cancer surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TEA group
Arm Type
Active Comparator
Arm Description
peri operative thoracic epidural block (TEA) via fentanyl-levo bupivacaine infusion.
Arm Title
RSB group
Arm Type
Active Comparator
Arm Description
peri operative rectus sheath block (RSB) via fentanyl-levo bupivacaine infusion.
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural block (TEA)
Other Intervention Name(s)
Thoracic epidural analgesia
Intervention Description
Under complete aseptic precautions and before induction of GA, thoracic epidural catheter was inserted using a 17 gauge, Tuohy epidural needle by a midline approach. T9-T10 interspace was chosen for the injection after skin infiltration by 5 mL of lidocaine 1%. The epidural space was identified by the loss of resistance technique then the catheter was introduced 2 cm into the epidural space, and epidural test dose of 3 mL of lidocaine 2% with 1:200,000 adrenaline was injected to exclude vascular or subarachnoid position.
Intervention Type
Procedure
Intervention Name(s)
Rectus sheath block (RSB)
Intervention Description
Under aseptic technique, the rectus muscle was imaged with the ultrasound probe, A broadband (5-12 MHz) linear array probe of Sonosite ™ 3000 ultrasound (FUJIFILM, Sonosite EDGE II -UAS) in a transverse orientation at or immediately above the level of the umbilicus, with an imaging depth of 4-6 cm. Inserting the needle: An 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique in an angle of 45 degrees to the skin. (posterior rectus sheath and fascia transversalis). Under direct vision, the needle tip was advanced to the desired position where 20 mL of (levo-bupivacaine 0.25% Fentanyl 30 μg) were injected causing hydro dissection of the rectus muscle away from the posterior rectus sheath. The technique is repeated on the opposite side.
Primary Outcome Measure Information:
Title
assessing a change in VAS score with cough
Description
assessing a change in Pain severity by VAS score with cough (0-10) 0=no pain 10=worst pain ever
Time Frame
at 0, 4, 8, 12, 18, 24, 36 and 48 hours post operative.
Secondary Outcome Measure Information:
Title
assessing a change of MAP
Description
assessing a change in Mean arterial pressure from baseline reading
Time Frame
at baseline , 4, 8, 12, 18, 24, 36 and 48 hours post operative.

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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa A. Elzohry, MD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Egypt Cancer Institute, Assiut University, Arab Republic of Egypt
City
Assiut
ZIP/Postal Code
0020
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Peri-operative Rectus Sheath Block Versus TEA Abdominal Surgeries

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