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Rectus Sheath Block: Postoperative Analgesia and Proinflammatory Cytokines

Sponsor
Assiut University (Other)
Overall Status
Completed
CT.gov ID
NCT03074097
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
13.8
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bupivacaine 0.25%
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official Title:
Effect of Rectus Sheath Block on Opioid Consumption and Serum Level of TNF-α and IL-6 After Radical Prostatectomy
Actual Study Start Date :
Mar 5, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Apr 28, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rectus Sheath

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

Drug: Bupivacaine 0.25%
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
Other Names:
  • Plain marcaine

    		•
    No Intervention: Control

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

    Outcome Measures

    Primary Outcome Measures

    1. cumulative opioid consumption [24 hours postoperative]

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

    Secondary Outcome Measures

    1. Numerical rating scale (NRS) [24 hours postoperative]

      evaluate postoperative pain intensity by NRS

    2. time to first anlgesic request [24 hours postoperative]

      the first time receiving IV-PCA bolus injection

    3. serum levels of TNF-α [at 24 hours postoperative]

      Proinflamatory cytokines

    4. Serum level of IL-6 [at 24 hours postoperative]

      Proinflamatory cytokines

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut university faculty of medicine Assiut Egypt

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Waleed S Farrag, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03074097
    Other Study ID Numbers:
    • 17100391
    First Posted:
    Mar 8, 2017
    Last Update Posted:
    Feb 22, 2018
    Last Verified:
    Feb 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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
    Keywords provided by Abdelrady S Ibrahim, MD, Assistant professor of anesthesia and ICU, Assiut University
    Rectus sheath block, Postoperative pain,TNF alpha and IL-6
    Additional relevant MeSH terms:
    Pain, Postoperative
    Bupivacaine

    Study Results

    No Results Posted as of Feb 22, 2018