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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Drug: Hydromorphone combined with ropivacaine; Drug: Ropivacaine

• Registration Number: NCT06218160
• Lead Sponsor: Second Hospital of Jilin University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-25
• Study First Submitted: 2023-12-30
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydromorphone combined with ropivacaine	Hydromorphone combined with ropivacaine	The posterior quadrat block was performed by adding 1mg hydromorphone to 0.375% ropivacaine in a total of 30ml.
ropivacaine	Ropivacaine	A mixture of 0.375% ropivacaine for a total of 30ml was performed for posterior quadrate block.

Primary Outcome Measures

Name	Time	Method
Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.	From the start of anesthesia until two days after surgery.	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.
Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.	From the end of surgery until two days 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).

Secondary Outcome Measures

Name	Time	Method
The occurrence of postoperative adverse reactions.	The operation ended two days after surgery.	The rates of postoperative nausea, vomiting and dizziness were compared between the two groups.

Trial Locations

Locations (1)

Second Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China