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

NCT03228797 | Completed

• 1 other identifier: MRC-09/2014_07
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Conditions

Abdominal Pain

Keywords

pain

Outcome Measures

Primary Outcomes (1)

• 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

  2 days

Study Arms (3)

Group I

ACTIVE COMPARATOR

( 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.

Procedure: an ultrasound guided rectus sheath block

Group II

ACTIVE COMPARATOR

( 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.

Procedure: multiholed catheter

Group III

ACTIVE COMPARATOR

( 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.

Procedure: an ultrasound guided rectus sheath block &multiholed catheter

Interventions

an ultrasound guided rectus sheath block PROCEDURE

Also known as: naropine 0.5%

Group I

multiholed catheter PROCEDURE

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

Also known as: naropine 0.2%

Group II

an ultrasound guided rectus sheath block &multiholed catheter PROCEDURE

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.

Also known as: naropine 0.5% & naropine/ropivacaine 0.2%

Group III

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dr Manar Mamdouh Fahmy Elsharkawi: lead

MeSH Terms

Conditions

Abdominal Pain; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• DR.HANY GREISS, consultant

  DHA -Rashid hospital

  PRINCIPAL INVESTIGATOR

• DR.MANAR MAMADOUH, specialist

  DHA -Rashid hospital

  PRINCIPAL INVESTIGATOR

• DR.MANSOUR NADHRI, consultant

  DHA -Rashid hospital

  STUDY DIRECTOR

• DR.OSAMA ALANI, senior specialist

  DHA -Rashid hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: anaesthesiologist

Model Details: comparative study between 3 groups using ropivacaine

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 25, 2017
• Study Start: February 11, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: August 25, 2017

Record last verified: 2017-08