The Addition of Hydromorphone to Local Anesthetics for the Repair of Inguinal Hernias in Elderly Patients

Inguinal Hernia Clinical Trial

Official title:

A Randomized Controlled Study of Ropivacaine Combined With Hydromorphone to Block Lumbar Muscle in Elderly Inguinal Hernia Repair.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06218160
• Other study ID #: 2022/148
• Status: Completed
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: December 25, 2023

Study information

• Verified date: January 2024
• Source: Second Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the clinical and postoperative analgesic effects of hydromorphone combined with ropivacaine and ropivacaine alone in quadrangular muscle block for open inguinal hernia in elderly patients.

Description:

Elderly patients selected for Lichtenstein hernia repair in our hospital who met the inclusion and exclusion criteria and obtained informed consent were included in this trial, and were randomly divided into experimental group by random number table method: 0.375% ropivacaine combined with hydromorphone block group, and control group: 0.375% ropivacaine block group alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 25, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Age 60 and above.
• Admission to hospital for open inguinal hernia surgery is consistent with the -indications of this surgical modality, ASA grades 1 to 3.
• No recent use of sedatives, opioids, or other analgesics.
• Good compliance, signed informed consent.
• Complete clinical data.

Exclusion Criteria:

• There are serious cardiovascular and cerebrovascular diseases.
• Abdominal infection.
• Coagulation dysfunction or receiving anticoagulation therapy.
• Local anesthesia drug allergy.
• Can not cooperate with the corresponding operation, suffering from mental illness.
• Previous surgical history of the corresponding position in the abdomen that may interfere with the surgical process of this study.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Drug:
• Hydromorphone combined with ropivacaine
1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block
• Ropivacaine
A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block

Locations

Country	Name	City	State
China	Second Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Second Hospital of Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.	Visual analogue scale (VAS) was used to score the postoperative pain at 6,12,18,24,48h.The score ranges from 0 (no pain) to 10 (most severe pain). The change was equal to the score difference between the two groups at different observation time points (6,12,18,24,48h).	From the end of surgery until two days after surgery.
Primary	Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.	The range of the effective time of anesthesia minus the start time of anesthesia and the maintenance time minus the start time of anesthesia are respectively.The unit of time is minutes.	From the start of anesthesia until two days after surgery.
Secondary	The occurrence of postoperative adverse reactions.	The rates of postoperative nausea, vomiting and dizziness were compared between the two groups.	The operation ended two days after surgery.