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

NCT05576675 | Completed Phase 3

• 1 other identifier: xijingHospital
• Study Type: interventional
• Target: 4,342
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Surgery

Keywords

patient-controlled intravenous analgesia; gastrointestinal surgery

Outcome Measures

Primary Outcomes (2)

• the incidence of insufficient static and dynamic analgesia dynamic analgesia

  VAS ≥ 4

  24 hours after operation

• the incidence of insufficient static and dynamic analgesia dynamic analgesia

  VAS ≥ 4

  48 hours after operation

Secondary Outcomes (2)

• the incidence of adverse reactions

  24 hours after operation

• the incidence of adverse reactions

  48 hours after operation

Other Outcomes (2)

• first exhaust time

  immediately after operation

• first ambulation time

  immediately after operation

Study Arms (3)

SN group

EXPERIMENTAL

sufentanil 100 μ g + nalbuphine 40 mg

Drug: sufentanil + nalbuphine

HN group

EXPERIMENTAL

hydromorphone 10 mg+ nalbuphine 40 mg

Drug: hydromorphone + nalbuphine

S group

EXPERIMENTAL

sufentanil 200 μ g,

Drug: Sufentanil

Interventions

sufentanil + nalbuphine DRUG

sufentanil 100 μ g + nalbuphine 40 mg

SN group

Sufentanil DRUG

sufentanil 200 μ g

S group

hydromorphone + nalbuphine DRUG

hydromorphone 10 mg+ nalbuphine 40 mg

HN group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

YANLI

XIan, Shanxi, 710032, China

Location

MeSH Terms

Interventions

Sufentanil; Nalbuphine; Hydromorphone

Intervention Hierarchy (Ancestors)

Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Morphine Derivatives

Study Officials

• Yan LI

  The First Affiliated Hospital of the Air Force Medical Universtiy

  STUDY CHAIR

• jing LIN

  The First Affiliated Hospital of the Air Force Medical Universtiy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 12, 2022
• Study Start: May 1, 2018
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)