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

Gastrointestinal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05576675
• Other study ID #: xijingHospital
• Status: Completed
• Phase: Phase 3
• Start date: May 1, 2018
• Est. completion date: March 31, 2022

Study information

• Verified date: August 2022
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4342
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

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

Related Conditions & MeSH terms

• Gastrointestinal Surgery

Intervention

Drug:
• sufentanil + nalbuphine
sufentanil 100 µ g + nalbuphine 40 mg
• Sufentanil
sufentanil 200 µ g
• hydromorphone + nalbuphine
hydromorphone 10 mg+ nalbuphine 40 mg

Locations

Country	Name	City	State
China	YANLI	XIan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	first exhaust time	first exhaust time	immediately after operation
Other	first ambulation time	first ambulation time	immediately after operation
Primary	the incidence of insufficient static and dynamic analgesia dynamic analgesia	VAS = 4	24 hours after operation
Primary	the incidence of insufficient static and dynamic analgesia dynamic analgesia	VAS = 4	48 hours after operation
Secondary	the incidence of adverse reactions	dizziness, nausea and vomiting	24 hours after operation
Secondary	the incidence of adverse reactions	dizziness, nausea and vomiting	48 hours after operation