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Use of Intrathecal Analgesia in Appendectomy

Primary Purpose

Anesthesia, Analgesia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
25 mcg fentanyl
250 mcg alfentanil
Sponsored by
Nigde Omer Halisdemir University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anesthesia focused on measuring intrathecally fentanyl, alfentanil, visual pain scale, analgesia

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals who will undergo laparoscopic appendectomy operation and volunteer to participate in the study were included.

Exclusion Criteria:

  • Individuals who meet the criteria but are not volunteers
  • Previously underwent appendectomy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group I

    Group II

    Arm Description

    25 mcg fentanyl intrathecally

    250 mcg alfentanil intrathecally

    Outcomes

    Primary Outcome Measures

    Patients diagnosis with appendicitis
    50 volunteer patients diagnosis with appendicitis by laboratory tests and clinical diagnosis methods in general surgery clinic, aged 20-60 years with American Society of Anesthesiologists Classification I-II (ASA I-II) without contraindication for spinal anesthesia, scheduled for laparoscopic appendectomy operation were included. The patients were randomly assigned into two group.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2019
    Last Updated
    December 10, 2019
    Sponsor
    Nigde Omer Halisdemir University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04196946
    Brief Title
    Use of Intrathecal Analgesia in Appendectomy
    Official Title
    Comparison of Bupivacaine-Fentanyl and Bupivacaine-Alfentanil Used Intrathecally in Laparoscopic Appendectomy Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2, 2013 (Actual)
    Primary Completion Date
    September 2, 2015 (Actual)
    Study Completion Date
    September 2, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Nigde Omer Halisdemir University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Acute appendicitis which is the most common cause of acute abdominal pain, is an acute inflammation of appendix vermiformis. Appendectomy operations can be performed as laparoscopic and open surgery. Addition of opioids to intrathecal local anesthetics to improve the quality of preoperative analgesia is an increasingly used method in recent years. The aim of this study is to compare bupivacaine-fentanyl and bupivacaine-alfentanil which are used intrathecally to create motor and sensory block. 50 volunteer patients who were diagnosed as appendicitis by laboratory tests and clinical diagnostic methods in general surgery clinic and classified as American Society of Anesthesiologists Classification I-II (ASA Class I-II) aged between 20-60 years scheduled for laparoscopic appendectomy operation, were included in this study. The patients were randomly assigned into two groups, Group I and Group II. Patients received spinal anesthesia with either 10 mg heavy bupivacaine (2 cc)+25 mcg fentanyl (0.5 cc) intrathecally (Group I, n=25) or 10 mg heavy bupivacaine (2 cc)+250 mcg alfentanil (0.5 cc) intrathecally (Group II, n=25).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anesthesia, Analgesia
    Keywords
    intrathecally fentanyl, alfentanil, visual pain scale, analgesia

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group I
    Arm Type
    Experimental
    Arm Description
    25 mcg fentanyl intrathecally
    Arm Title
    Group II
    Arm Type
    Experimental
    Arm Description
    250 mcg alfentanil intrathecally
    Intervention Type
    Drug
    Intervention Name(s)
    25 mcg fentanyl
    Other Intervention Name(s)
    fentanyl
    Intervention Description
    Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group I received 10 mg hyperbaric bupivacaine (2 cc) and 25 mcg fentanyl (0.5 cc).
    Intervention Type
    Drug
    Intervention Name(s)
    250 mcg alfentanil
    Other Intervention Name(s)
    alfentanil
    Intervention Description
    Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group II received 10 mg hyperbaric bupivacaine (2 cc) and 250 mcg alfentanil (0.5 cc) intrathecally.
    Primary Outcome Measure Information:
    Title
    Patients diagnosis with appendicitis
    Description
    50 volunteer patients diagnosis with appendicitis by laboratory tests and clinical diagnosis methods in general surgery clinic, aged 20-60 years with American Society of Anesthesiologists Classification I-II (ASA I-II) without contraindication for spinal anesthesia, scheduled for laparoscopic appendectomy operation were included. The patients were randomly assigned into two group.
    Time Frame
    With the completion of laparoscopic appendectomy operation, average 30 minutes to 1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Individuals who will undergo laparoscopic appendectomy operation and volunteer to participate in the study were included. Exclusion Criteria: Individuals who meet the criteria but are not volunteers Previously underwent appendectomy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mehtap Balcı, M.D.
    Organizational Affiliation
    Nigde Omer Halisdemir University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Use of Intrathecal Analgesia in Appendectomy

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