Clinical trial NCT05576675: Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
Official title: Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastrointestinal Surgery
Keywords: patient-controlled intravenous analgesia
gastrointestinal surgery
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 4342
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: the incidence of insufficient static and dynamic analgesia dynamic analgesia
timeFrame: 24 hours after operation
measure: the incidence of insufficient static and dynamic analgesia dynamic analgesia
timeFrame: 48 hours after operation
Secondary outcomes:
measure: the incidence of adverse reactions
timeFrame: 24 hours after operation
measure: the incidence of adverse reactions
timeFrame: 48 hours after operation
Other outcomes:
measure: first exhaust time
timeFrame: immediately after operation
measure: first ambulation time
timeFrame: immediately after operation
Locations:
city: XIan
country: China
facility: YANLI
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of the Air Force Medical Universtiy
name: Yan LI
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital of the Air Force Medical Universtiy
name: jing LIN
role: STUDY_CHAIR
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