Use of Intrathecal Analgesia in Appendectomy

Comparison of Bupivacaine-Fentanyl and Bupivacaine-Alfentanil Used Intrathecally in Laparoscopic Appendectomy Surgery

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).

Study Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia
• Intervention / Treatment: Drug: 25 mcg fentanyl; Drug: 250 mcg alfentanil

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group I; 25 mcg fentanyl intrathecally	Drug: 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).; Other Names: fentanyl
EXPERIMENTAL: Group II; 250 mcg alfentanil intrathecally	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.; Other Names: alfentanil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	With the completion of laparoscopic appendectomy operation, average 30 minutes to 1 hour

Collaborators and Investigators

• Sponsor: Nigde Omer Halisdemir University
• Investigators: Principal Investigator: Mehtap Balcı, M.D., Nigde Omer Halisdemir University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2013
• Primary Completion (ACTUAL): September 2, 2015
• Study Completion (ACTUAL): September 2, 2019

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: analgesia; alfentanil; intrathecally fentanyl; visual pain scale
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Alfentanil
• Other Study ID Numbers: 2013/512

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No