Use of Intrathecal Analgesia in Appendectomy

Not Applicable

Completed

• Conditions: Anesthesia; Analgesia
• Interventions: Drug: 25 mcg fentanyl; Drug: 250 mcg alfentanil

• Registration Number: NCT04196946
• Lead Sponsor: Nigde Omer Halisdemir University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09-02
• Primary Completion: 2015-09-02
• Study Completion: 2019-09-02
• Status Verified: 2019-12
• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	25 mcg fentanyl	25 mcg fentanyl intrathecally
Group II	250 mcg alfentanil	250 mcg alfentanil intrathecally

Primary Outcome Measures

Name	Time	Method
Patients diagnosis with appendicitis	With the completion of laparoscopic appendectomy operation, average 30 minutes to 1 hour	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.