Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Post-operative Pain

NCT06721988 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202411042
• Study Type: interventional
• Target: 1,316
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to learn if the administration of oxycodone for preventive analgesia works to reduce the chronification of acute postoperative pain in adult participants undergoing major abdominal surgery. The main question it aims to answer is:

• Does administration of oxycodone before surgical incision reduce the occurrence of chronic pain or relieve the chronic pain symptoms 3 months after the operation? Researchers will compare oxycodone + parecoxib sodium to placebo + parecoxib sodium combinations to see if oxycodone works to reduce the chronification of acute postoperative pain. Participants will:
• Take oxycodone + parecoxib sodium or placebo + parecoxib sodium combinations before the surgical incision
• Cooperate with the follow-up staffs and complete some checkups or tests within 3 months after the operation.

Conditions

Oxycodone; Chronic Pain, Postoperative

Keywords

Oxycodone; Preventive analgesia; Chronification of acute postoperative pain

Outcome Measures

Primary Outcomes (2)

• Visceral pain scores in the surgical area at 90 days postoperatively.

  The pain scores will be assessed by the Numeric Rating Scale (NRS) and Brief Pain Inventory Scale-Short form (BPI-9). The NRS evaluates pain intensity on a 0-10 scale and the scores are grouped as no (NRS 0), mild (NRS 1-4), moderate (NRS 5-7), or severe pain (NRS 8-10). The BPI-9 is a 9-item questionnaire and each item is scored from 0 = no pain to 10 = worst pain. The BPI-9 is used to assess various aspects of pain severity and pain interference.

  90 days after the surgery

• The incidence of moderate to severe visceral pain at 90 days postoperatively.

  The incidence will be calculated as the ratio of the number of participants with moderate to severe visceral pain to the number of participants allocated to each group at 90 days after the surgery .

  90 days after the surgery

Secondary Outcomes (6)

• Somatic pain scores in the surgical area at 48 hours postoperatively;

  48 hours after the surgery

• Visceral pain scores in the surgical area at 48 hours postoperatively;

  48 hours after the surgery

• Incidence of moderate to severe visceral pain at 48 hours postoperatively;

  48 hours after the surgery

• Incidence of moderate to severe visceral pain in the surgical area at 30 days postoperatively;

  30 days after the surgery

• Incidence of moderate to severe somatic pain in the surgical area at 30 days postoperatively;

  30 days after the surgery

Study Arms (2)

OP group

EXPERIMENTAL

Participants in this group will receive oxycodone and parecoxib sodium before surgical incision.

Drug: oxycodone and parecoxib sodium combinations

PP group

PLACEBO COMPARATOR

Participants in this group will receive a placebo and parecoxib sodium before surgical incision.

Drug: Placebo and parecoxib sodium combinations

Interventions

oxycodone and parecoxib sodium combinations DRUG

Participants will receive 0.1ml/kg oxycodone (1mg/ml) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Oxycodone is administered 5 minutes after parecoxib sodium administration.

OP group

Placebo and parecoxib sodium combinations DRUG

Participants will receive 0.1ml/kg placebo (0.9% saline) and 2 ml parecoxib sodium (20 mg/ml) combinations after the anesthesia induction but before the surgical incision. Placebo is administered 5 minutes after parecoxib sodium administration.

PP group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I\~III；
• BMI ranging from 18 to 28 kg/m²；
• For elective laparoscopic-assisted major abdominal surgery under general anesthesia;
• Estimated surgical duration (from incision to the last suture of the skin) was at least 2 hours.

You may not qualify if:

• Pregnant or lactating patients;
• Patients diagnosed with septic shock or multiple organ failure within 14 days;
• Patients with preoperative severe electrolyte disorders;
• Patients with stroke, transient ischemic attack, or other similar events within the past 3 months
• Patients with unstable angina, myocardial infarction within the past 3 months; or presence of untreated arrhythmia or arrhythmia not well-controlled with treatment;
• Patients with diabetes, uncontrolled blood glucose levels, or diabetes complications such as diabetic ketoacidosis, hyperosmolar coma, diabetes-related infections, diabetic nephropathy, retinopathy, diabetic cardiomyopathy, diabetic peripheral neuropathy, diabetic foot, etc. before the surgery;
• Patients with severe liver dysfunction (Child-Pugh score \> 6), renal dysfunction (GFR \< 90 ml/(min•1.73m²));
• Exploratory surgeries, day surgeries, or surgeries that only involve opening and closing the abdomen;
• Blood pressure ≥180/110 mmHg at rest (≥Grade 3 hypertension according to the 2020 ISH Hypertension Guidelines); or systolic blood pressure \<90 mmHg or mean blood pressure \<65 mmHg;
• Patients participated in other drug trials within the past 3 months;
• Patients with communication difficulties, inability to understand pain scores or patient-controlled intravenous analgesia;
• Patients with consciousness disorders or other psychiatric illnesses;
• Patients with a confirmed or suspected history of substance abuse or long-term use of anesthetic sedatives and analgesics;
• Cancer patients have received neoadjuvant treatment or chemotherapy preoperatively;
• Allergic to the drugs used in this trial and their components.

Sponsors & Collaborators

• Ailin Luo: lead
• Jinhua Central Hospital: collaborator
• Minda Hospital of Hubei Minzu University: collaborator
• Taihe Hospital of Traditional Chinese Medicine: collaborator
• Qujing first people's Hospital: collaborator

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Oxycodone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Luo Ailin

  Department of Anesthesiology of Tongji hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luo Ailin

CONTACT

86-027-83665480; alluo@hust.edu.cn

Li Shiyong

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 27, 2024
• First Posted: December 9, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: December 9, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share