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A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Rectus Sheath Block for Midline Emergency Laparotomy

Primary Purpose

Abdominal Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
an ultrasound guided rectus sheath block
multiholed catheter
an ultrasound guided rectus sheath block &multiholed catheter
Sponsored by
Dr Manar Mamdouh Fahmy Elsharkawi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Abdominal Pain focused on measuring pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA-1 to ASA-3,emergency midline laparotomy

Exclusion Criteria:

  • ASA-4 & above,allergic patients to the study's medications ,morbid obeses patients,patient refusal,age below 18yrs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group I

    Group II

    Group III

    Arm Description

    ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.

    ( 20 patients) multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer, a10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 5ml/h.

    ( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.

    Outcomes

    Primary Outcome Measures

    self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days
    each item is scored (0-10)0=no pain& 10= the worst

    Secondary Outcome Measures

    Full Information

    First Posted
    July 6, 2017
    Last Updated
    August 24, 2017
    Sponsor
    Dr Manar Mamdouh Fahmy Elsharkawi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03228797
    Brief Title
    A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Rectus Sheath Block for Midline Emergency Laparotomy
    Official Title
    A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Transversus Abdominis Plane Block for Abdominoplasty
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    February 11, 2015 (Actual)
    Primary Completion Date
    September 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dr Manar Mamdouh Fahmy Elsharkawi

    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.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    aim of this study is to compare the postoperative analgesia provided bya continuous preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency laparotomy. anticoagulated patients
    Detailed Description
    Patients and Methods: This randomized prospective study will be carried out after the approval of Rashid Hospital's Research Ethical Committee and patient's written informed consent. Sixty adult patients , of both gender , 18-70 years old, ASA I-III who will be scheduled for emergency laparotomy with upper abdominal midline incision will be included in the study. Exclusion criteria will be patients with known allergic response or contraindications to paracetamol, parecoxib, morphine or ropivacaine and pregnant women The enrolled patients will be randomly assigned to one of three groups: Group I ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side. Group II ( 20 patients) for whom a 7.5 , 15 , 30 cm 19-gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision through an introducer peel-away needle. The length of the catheter will be established to guarantee homogenous distribution of the holes all along the length of the incision of the fascia. The catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 10 ml/h. Group III( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I. No premedication will be administered. General anesthesia will be induced using target controlled intravenous infusion (TCI) using remifentanil (1-10 ng/ml effect concentration ) and propofol ( 1-10 mcg/ml effect concentration) titrated to Bi-spectral index (BIS) value between 40-60.Once anesthesia level will be reached , succinyl choline 1mg/kg intravenously will be given. After the airway will be secured , TCI will be adjusted to maintain BIS value between 40 to 60.An initial dose of 0.1 mg/kg intravenous cisatracurium will be administered and further doses will be given according to neuromuscular monitoring maintaining a train of four (TOF) value of zero. Pre-incision , all patients will receive 15 mg/kg intravenous bolus and 40 mg intravenous parecoxib. 0.5 mg intravenous ketamine will be administered to avoid remifentanil's induced hyperalgesia. All patients will be mechanically ventilated to maintain normocapnia throughout the procedure. Standard intraoperative monitoring will include electrocardiography, pulse oximetry , automatic non-invasive blood pressure , end tidal capnography , Bi-spectral index and train of four monitoring. At the end of surgery and before extubation , patients who will be randomly assigned to Group I will receive an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side. For patients who will be assigned to either Group II or Group III , a 7.5 , 15 or 30 cm 19-gauge multiholed catheter will be inserted by the operating surgeon at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision through an introducer peel-away needle. The length of the catheter will be established to guarantee homogenous distribution of the holes all along the length of the incision of the fascia. The catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 10 ml/h. For patients who will be assigned to Group III will receive also an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side. Then the patients will be extubated and shifted to Post-Anesthesia Care Unit (PACU) where they will be monitored for heart rate , blood pressure , oxygen saturation by pulse oximetry and pain score using visual analogue scale (VAS) both at rest and deep breathing . These data will be recorded every 15 minutes for the first hour. After one hour , the patients will be discharged from PACU according to Modified Aldrete Scoring if they will reach a score of 9 or more. All patients will receive parecoxib 40 mg intravenously twice a day and paracetamol in a dose of 40 mg/kg intravenously in three divided doses regularly for 48 hours postoperatively. In the postoperative period, all the patients will be evaluated for their hemodynamic variables ( heart rate , respiratory rate , arterial blood pressure and arterial oxygen saturation ) and postoperative analgesia using VAS at rest and with deep breathing at 2,4,8,12,18,24,36 and 48 hours postoperatively. If the patient's VAS will reach 4 at any time in the 48 hours postoperatively, 0.1 mg/kg titrated intravenous morphine rescue analgesia will be administered and repeated if required to maintain VAS less than 4. All patients will respond to a quality of life questionnaire (QR 40) at 24 and 48 hours postoperatively.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Pain
    Keywords
    pain

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    comparative study between 3 groups using ropivacaine
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Active Comparator
    Arm Description
    ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.
    Arm Title
    Group II
    Arm Type
    Active Comparator
    Arm Description
    ( 20 patients) multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer, a10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 5ml/h.
    Arm Title
    Group III
    Arm Type
    Active Comparator
    Arm Description
    ( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.
    Intervention Type
    Procedure
    Intervention Name(s)
    an ultrasound guided rectus sheath block
    Other Intervention Name(s)
    naropine 0.5%
    Intervention Type
    Procedure
    Intervention Name(s)
    multiholed catheter
    Other Intervention Name(s)
    naropine 0.2%
    Intervention Description
    gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision
    Intervention Type
    Procedure
    Intervention Name(s)
    an ultrasound guided rectus sheath block &multiholed catheter
    Other Intervention Name(s)
    naropine 0.5% & naropine/ropivacaine 0.2%
    Intervention Description
    a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.
    Primary Outcome Measure Information:
    Title
    self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days
    Description
    each item is scored (0-10)0=no pain& 10= the worst
    Time Frame
    2 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: ASA-1 to ASA-3,emergency midline laparotomy Exclusion Criteria: ASA-4 & above,allergic patients to the study's medications ,morbid obeses patients,patient refusal,age below 18yrs
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    DR.HANY GREISS, consultant
    Organizational Affiliation
    DHA -Rashid hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    DR.MANAR MAMADOUH, specialist
    Organizational Affiliation
    DHA -Rashid hospital
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    DR.MANSOUR NADHRI, consultant
    Organizational Affiliation
    DHA -Rashid hospital
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    DR.OSAMA ALANI, senior specialist
    Organizational Affiliation
    DHA -Rashid hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Rectus Sheath Block for Midline Emergency Laparotomy

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