Effect of Preventive Analgesia with Oxycodone and Parecoxib Sodium on the Chronification of Acute Post-operative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAilin Luo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
oxycodone and parecoxib sodium combinations
DrugParticipants 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.
Placebo and parecoxib sodium combinations
DrugParticipants 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.
Treatment groups
1,316 Participants
are divided into 2 treatment groupsGroup A: OP groupExperimental treatment 1 intervention
Group B: PP groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
90 days after the surgery2
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 .
Time frame
90 days after the surgerySecondary outcomes
1
Somatic pain scores in the surgical area at 48 hours postoperatively;
The pain scores will be assessed by the NRS and BPI-9 scales as described above.
Time frame
48 hours after the surgery2
Visceral pain scores in the surgical area at 48 hours postoperatively;
The pain scores will be assessed by the NRS and BPI-9 scales as described above.
Time frame
48 hours after the surgery3
Incidence of moderate to severe visceral pain at 48 hours 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 48 hours after the surgery.
Time frame
48 hours after the surgery4
Incidence of moderate to severe visceral pain in the surgical area at 30 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 30 days after the surgery.
Time frame
30 days after the surgeryLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Ailin Luo
Lead sponsor
Tongji Hospital
Sponsor institution
Jinhua Central Hospital
Collaborator
Minda Hospital of Hubei Minzu University
Collaborator
Taihe Hospital of Traditional Chinese Medicine
Collaborator
Qujing first people's Hospital
Collaborator
Source ClinicalTrials.gov
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