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
About this trial
This is an interventional supportive care trial for Anesthesia focused on measuring intrathecally fentanyl, alfentanil, visual pain scale, analgesia
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
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
NCT ID
NCT04196946
First Posted
December 4, 2019
Last Updated
December 10, 2019
Sponsor
Nigde Omer Halisdemir University
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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