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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Surgery
• Intervention / Treatment: Drug: sufentanil + nalbuphine; Drug: hydromorphone + nalbuphine; Drug: Sufentanil

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

• Study Type: Interventional
• Enrollment (Actual): 4342
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanxi
    • XIan, Shanxi, China, 710032
      • YANLI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SN group; sufentanil 100 μ g + nalbuphine 40 mg	Drug: sufentanil + nalbuphine; sufentanil 100 μ g + nalbuphine 40 mg
Experimental: HN group; hydromorphone 10 mg+ nalbuphine 40 mg	Drug: hydromorphone + nalbuphine; hydromorphone 10 mg+ nalbuphine 40 mg
Experimental: S group; sufentanil 200 μ g,	Drug: Sufentanil; sufentanil 200 μ g

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of adverse reactions	dizziness, nausea and vomiting	24 hours after operation
the incidence of adverse reactions	dizziness, nausea and vomiting	48 hours after operation

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
first exhaust time	first exhaust time	immediately after operation
first ambulation time	first ambulation time	immediately after operation

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: September 1, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 12, 2022

Study Record Updates

• Last Update Posted (Actual): October 12, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: gastrointestinal surgery; patient-controlled intravenous analgesia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Nalbuphine; Sufentanil; Dsuvia; Hydromorphone
• Other Study ID Numbers: xijingHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No