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Use of Intrathecal Analgesia in Appendectomy

NCT04196946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-12-12

No results posted yet for this study

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).

Conditions

  • Anesthesia
  • Analgesia

Interventions

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).

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.

Sponsors & Collaborators

  • Nigde Omer Halisdemir University

    lead OTHER

Principal Investigators

  • Mehtap Balcı, M.D. · Nigde Omer Halisdemir University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-09-02
Primary Completion
2015-09-02
Completion
2019-09-02

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04196946 on ClinicalTrials.gov