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Rectus Sheath Block Versus Thoracic Epidural Effect on Diaphragmatic Function After Elective Midline Abdominal Surgery (Rectus)

Primary Purpose

Acute Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Rectus Sheath Catheter Block
Epidural Catheter Block
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age: 18-50 years.
  • Sex: both males and females.
  • BMI< 30kg/m2.
  • ASA physical status: 1, II and III.
  • Elective abdominal surgery with midline incisions.

Exclusion Criteria:

  • Patient refusal.
  • Infection at injection site
  • Coagulation disorders.
  • Allergy to study medications.
  • Pregnancy.
  • Respiratory tract infection within the last 2 weeks.
  • Urgent abdominal surgery

Sites / Locations

  • Assiut university main hospital, ICUsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Rectus sheath catheter block

Epidural Catheter block

Arm Description

Patients will receive ultrasound-guided rectus sheath block with catheter insertion performed after induction of general anesthesia and before surgery.

Patients will receive thoracic epidural at the level of T7 performed before anesthesia induction.

Outcomes

Primary Outcome Measures

Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm
The measurements of diaphragmatic motion will be attained at the posterior surface of the diaphragm. From the tracings on M-mode, the distance between echogenic lines (DIA) in centimeters and diaphragmatic inspiratory/expiratory velocity in centimeters/second during quiet, deep, and sniff breathing will be measured on the frozen images.

Secondary Outcome Measures

Verbal Rating Scale
Verbal rating pain scale (VRS) (Ranging from 0 to 4), where 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain and lastly 4 =excruciating pain) will be recorded at rest and upon patient coughing; on admission to PACU (baseline), and 2, 4, 6, 12, and 48h postoperatively.
Forced Vital Capacity/L
Measurements of Forced vital capacity (FVC) will be measured by the use of hand-held spirometer (One-flow®, Clement Clarke, U.K). At each assessment, the largest values of FVC will be recorded.

Full Information

First Posted
September 29, 2018
Last Updated
July 13, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03725527
Brief Title
Rectus Sheath Block Versus Thoracic Epidural Effect on Diaphragmatic Function After Elective Midline Abdominal Surgery
Acronym
Rectus
Official Title
Comparison of the Effect of Rectus Sheath Block Versus Thoracic Epidural Analgesia on Diaphragmatic Function After Elective Abdominal Surgery With Midline Incision
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be undertaken to compare the respiratory and analgesic effects of thoracic epidural versus ultrasound guided rectus sheath block analgesia after elective abdominal surgery with midline incision.
Detailed Description
A major proportion of pain experienced by patients undergoing abdominal surgeries is due to somatic pain signals derived from the abdominal wall. The central portion of anterior abdominal wall components (skin, muscles and parietal peritoneum) is innervated by sensory neurons branching from the anterior rami of spinal nerves T7 to T1. These neurons lie between the rectus abdominis muscle and posterior rectus sheath, and pierce the rectus muscle close to the midline. The tendinous intersections of the rectus muscle do not fuse with the posterior rectus sheath, thereby allowing the injectate to spread cephalo-caudally within this potential space. Rectus sheath (RS) block has been described for any midline abdominal incisions (epigastric and umbilical hernia repairs). As visceral pain becomes attenuated by the 2nd postoperative day, rectus sheath block can also be administered for midline laparotomy. As a single bolus of the local anesthetic has a maximum duration of 12 hours. it is necessary to insert a catheter into this space to allow either a continuous infusion of local anesthetic, or repeated boluses of local anesthetic every 8 to 12 hours for 48 to 72 hours post-operatively. However, the effects of rectus sheath block catheter analgesia on the respiratory function after abdominal surgery with midline incisions are still under investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rectus sheath catheter block
Arm Type
Active Comparator
Arm Description
Patients will receive ultrasound-guided rectus sheath block with catheter insertion performed after induction of general anesthesia and before surgery.
Arm Title
Epidural Catheter block
Arm Type
Active Comparator
Arm Description
Patients will receive thoracic epidural at the level of T7 performed before anesthesia induction.
Intervention Type
Procedure
Intervention Name(s)
Rectus Sheath Catheter Block
Other Intervention Name(s)
RSC
Intervention Description
Sonar guided RSC will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration.
Intervention Type
Procedure
Intervention Name(s)
Epidural Catheter Block
Other Intervention Name(s)
EPiC
Intervention Description
Sonar-guided epidurals will be performed with a 17-gauge Tuohy needle and 19 G flex-tip catheter. Using an LOR (loss of resistance) to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection.
Primary Outcome Measure Information:
Title
Diaphragmatic inspiratory amplitude during quiet/deep breathing (DIA)/cm
Description
The measurements of diaphragmatic motion will be attained at the posterior surface of the diaphragm. From the tracings on M-mode, the distance between echogenic lines (DIA) in centimeters and diaphragmatic inspiratory/expiratory velocity in centimeters/second during quiet, deep, and sniff breathing will be measured on the frozen images.
Time Frame
48 hours Postoperative
Secondary Outcome Measure Information:
Title
Verbal Rating Scale
Description
Verbal rating pain scale (VRS) (Ranging from 0 to 4), where 0=no pain, 1=mild pain, 2=moderate pain, 3=severe pain and lastly 4 =excruciating pain) will be recorded at rest and upon patient coughing; on admission to PACU (baseline), and 2, 4, 6, 12, and 48h postoperatively.
Time Frame
48 hours Postoperatively
Title
Forced Vital Capacity/L
Description
Measurements of Forced vital capacity (FVC) will be measured by the use of hand-held spirometer (One-flow®, Clement Clarke, U.K). At each assessment, the largest values of FVC will be recorded.
Time Frame
48 hours Postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18-50 years. Sex: both males and females. BMI< 30kg/m2. ASA physical status: 1, II and III. Elective abdominal surgery with midline incisions. Exclusion Criteria: Patient refusal. Infection at injection site Coagulation disorders. Allergy to study medications. Pregnancy. Respiratory tract infection within the last 2 weeks. Urgent abdominal surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hala S Abdelghaffar, MD
Phone
+2 01003812011
Email
hallasaad@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beshoy B Bolis, MBBCH
Phone
+2 01273774057
Email
bbalbagh@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hala Abdelghaffar
Organizational Affiliation
Professor in anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university main hospital, ICUs
City
Assiut
State/Province
Assiut Governorate
ZIP/Postal Code
715715
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hala S Abdelghaffar, MD
Phone
01003812011
Ext
+2 088
Email
hallasaad@yahoo.com
First Name & Middle Initial & Last Name & Degree
Beshoy B Bolis, MBBCH
Phone
+2 01273774057
Email
bbalbagh@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Rectus Sheath Block Versus Thoracic Epidural Effect on Diaphragmatic Function After Elective Midline Abdominal Surgery

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