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Use of Intrathecal Analgesia in Appendectomy

NCT ID: NCT04196946

Last Updated: 2019-12-12

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

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-02

Study Completion Date

2019-09-02

Brief Summary

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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).

Detailed Description

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Conditions

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Anesthesia Analgesia

Keywords

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intrathecally fentanyl alfentanil visual pain scale analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I

25 mcg fentanyl intrathecally

Group Type EXPERIMENTAL

25 mcg fentanyl

Intervention Type DRUG

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).

Group II

250 mcg alfentanil intrathecally

Group Type EXPERIMENTAL

250 mcg alfentanil

Intervention Type DRUG

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.

Interventions

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25 mcg fentanyl

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

250 mcg alfentanil

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.

Intervention Type DRUG

Other Intervention Names

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fentanyl alfentanil

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nigde Omer Halisdemir University

OTHER

Sponsor Role lead

Responsible Party

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Mehtap Balcı

Anesthesiology and Reanimation Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mehtap Balcı, M.D.

Role: PRINCIPAL_INVESTIGATOR

Nigde Omer Halisdemir University

Other Identifiers

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2013/512

Identifier Type: -

Identifier Source: org_study_id