Use of Intrathecal Analgesia in Appendectomy

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04196946

Enrollment

Registered

2019-12-12

Start date

2013-09-02

Completion date

2019-09-02

Last updated

2019-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Anesthesia

Keywords

intrathecally fentanyl, alfentanil, visual pain scale, analgesia

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).

Interventions

DRUG25 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).

DRUG250 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026