Efficacy Study of Rectus Sheath Block to Control Postoperative Pain

NCT ID: NCT02115087

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-01-31

Brief Summary

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The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.

Detailed Description

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Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.

Conditions

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Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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ultrasound guided rectus sheath block

Ultrasound guided rectus sheath block

Group Type EXPERIMENTAL

ultrasound guided rectus sheath block

Intervention Type PROCEDURE

the application of rectus sheath block with ultrasound guidance

iv morphine

0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

Interventions

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ultrasound guided rectus sheath block

the application of rectus sheath block with ultrasound guidance

Intervention Type PROCEDURE

Morphine

Intervention Type DRUG

Other Intervention Names

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US guided rectus sheath block

Eligibility Criteria

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Inclusion Criteria

* ASA physical status I-II
* 3-15 years of age children
* Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision

Exclusion Criteria

* ASA physical status III and above
* Parents who did not consider to participate in the study
* Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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Ersel GULEC

Assist.Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dilek Ozcengiz, Prof.

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Cukurova University Faculty of Medicine

Locations

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Department of Anesthesiology, Cukurova University Faculty of Medicine

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.

Reference Type BACKGROUND
PMID: 21377070 (View on PubMed)

Other Identifiers

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UGRSB-123

Identifier Type: -

Identifier Source: org_study_id

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