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Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine 0.25%
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Rectus sheath block, Postoperative pain,TNF alpha and IL-6

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia.

Exclusion criteria:

Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.

Sites / Locations

  • Assiut university faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Rectus Sheath

Control

Arm Description

Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia

Control group: the patients did not receive any intervention after anaesthesia induction.

Outcomes

Primary Outcome Measures

cumulative opioid consumption
study the effect of RSB on cumulative opioid consumption at 24 hours

Secondary Outcome Measures

Numerical rating scale (NRS)
evaluate postoperative pain intensity by NRS
time to first anlgesic request
the first time receiving IV-PCA bolus injection
serum levels of TNF-α
Proinflamatory cytokines
Serum level of IL-6
Proinflamatory cytokines

Full Information

First Posted
February 27, 2017
Last Updated
February 21, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03074097
Brief Title
Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines
Official Title
Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-α and IL-6 After Radical Prostatectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
March 5, 2015 (Actual)
Primary Completion Date
February 1, 2016 (Actual)
Study Completion Date
April 28, 2016 (Actual)

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
Good quality of postoperative analgesia would lead to attenuate or prevent the adverse effects on the common functions of the immune system. We compared the effect of epidural analgesia versus rectus sheath block on postoperative pain and proinflammatory cytokines following malignant urological surgery.
Detailed Description
Study groups: 60 patients were included in the study randomly allocated into two groups of 30 patients. Rectus sheath group (RSB): Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia. Control group: the patients did not receive any intervention after anaesthesia induction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Rectus sheath block, Postoperative pain,TNF alpha and IL-6

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rectus Sheath
Arm Type
Active Comparator
Arm Description
Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group: the patients did not receive any intervention after anaesthesia induction.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.25%
Other Intervention Name(s)
Plain marcaine
Intervention Description
Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia
Primary Outcome Measure Information:
Title
cumulative opioid consumption
Description
study the effect of RSB on cumulative opioid consumption at 24 hours
Time Frame
24 hours postoperative
Secondary Outcome Measure Information:
Title
Numerical rating scale (NRS)
Description
evaluate postoperative pain intensity by NRS
Time Frame
24 hours postoperative
Title
time to first anlgesic request
Description
the first time receiving IV-PCA bolus injection
Time Frame
24 hours postoperative
Title
serum levels of TNF-α
Description
Proinflamatory cytokines
Time Frame
at 24 hours postoperative
Title
Serum level of IL-6
Description
Proinflamatory cytokines
Time Frame
at 24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patients their age over 40 years, classified ASA I, II or III, undergoing radical resection of cancer prostate, through midline abdominal incision under general anaesthesia. Exclusion criteria: Contraindications to rectus sheath block as patient refusal, coagulopathy, local infection and allergy to bupivacaine. Planned transverse or oblique abdominal incision, extensive existing midline abdominal scarring or pre-existing chronic abdominal pain.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed S Farrag
Organizational Affiliation
Assiut University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university faculty of medicine
City
Assiut
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
18155056
Citation
Hong JY, Lim KT. Effect of preemptive epidural analgesia on cytokine response and postoperative pain in laparoscopic radical hysterectomy for cervical cancer. Reg Anesth Pain Med. 2008 Jan-Feb;33(1):44-51. doi: 10.1016/j.rapm.2007.07.010.
Results Reference
background

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Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

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