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Completed

NCT Number: NCT05576675

Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery

Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May 2018 to March 2022 were collected retrospectively. The patient-controlled intravenous analgesia regimen in this study was composed of different opioid receptor drugs：sufentanil combined with nalbuphine group (SN group) and Hydromorphone combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine 40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml, background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the three groups were collected, the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected, evaluate the analgesic effect of combination of different opioid receptor drugs and single opioid receptor drugs in PCIA after gastrointestinal surgery.

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Key information

Conditions

Gastrointestinal Surgery

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

YANLI

XIan, Shanxi, 710032, China

About this study

Control group：S group Test group：SN group and HN group Observation index：the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions（drowsiness, nausea and vomiting, respiratory depression, dizziness） at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-75 years ,there is no gender limit，ASA grade Ⅰ-Ⅱ

Exclusion criteria

  • BMI > 35 kg/m2, history of upper abdominal surgery, history of analgesic or hormone use before operation, history of depression or chronic pain before operation, infection before operation and ICU after operation

Treatment and study plan

sufentanil + nalbuphine

Drug

sufentanil 100 μ g + nalbuphine 40 mg

Sufentanil

Drug

sufentanil 200 μ g

hydromorphone + nalbuphine

Drug

hydromorphone 10 mg+ nalbuphine 40 mg

Primary outcomes

  1. the incidence of insufficient static and dynamic analgesia dynamic analgesia

    Time frame: 24 hours after operation

    VAS ≥ 4

  2. the incidence of insufficient static and dynamic analgesia dynamic analgesia

    Time frame: 48 hours after operation

    VAS ≥ 4

Secondary outcomes

  1. the incidence of adverse reactions

    Time frame: 24 hours after operation

    dizziness, nausea and vomiting

  2. the incidence of adverse reactions

    Time frame: 48 hours after operation

    dizziness, nausea and vomiting

Other outcomes

  1. first exhaust time

    Time frame: immediately after operation

    first exhaust time

  2. first ambulation time

    Time frame: immediately after operation

    first ambulation time

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 12, 2022
Registry last updated
Oct 12, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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