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Completed

NCT Number: NCT06218160

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

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hydromorphone combined with ropivacaine

Drug

1mg hydromorphone was added to 0.375% ropivacaine for a total of 30ml to perform quadrat block

Other names: Quadratus lumbois block

Ropivacaine

Drug

A mixture of 0.375% ropivacaine for a total of 30ml was used for quadrate block

Other names: Quadratus lumbois block

Primary outcomes

  1. Related indexes of anesthesia effect: pain after surgery, 6, 12, 18,24, 48h after surgery.

    Time frame: 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).

  2. Related indexes of anesthesia effect: time of onset of anesthesia, duration of anesthesia maintenance.

    Time frame: 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.

Secondary outcomes

  1. The occurrence of postoperative adverse reactions.

    Time frame: The operation ended two days after surgery.

    The rates of postoperative nausea, vomiting and dizziness were compared between the two groups.

Sponsors and collaborators

Lead sponsor

Second Hospital of Jilin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2024
Registry last updated
Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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