Sequential Method Determination of Oxycodone for Thoracoscope Surgery Median Effective Dose of Acute Pain Treatment

NCT ID: NCT06534801

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2026-04-01

Brief Summary

The goal of this clinical trial is to measure the median effective dose of oxycodone for the treatment of acute pain after thoracoscopic lobectomy. This clinical trial was divided into two groups based on age, Group I (Age < 65 years old) and Group II (Age ≥65 years old). We used the sequential allocation designed by Dixon. The initial oxycodone dose was set to 0.1 mg/kg.A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point was included as the first case for ED50 estimation in each group.The study was conducted until 7 crossover points were collected

Conditions

Oxycodone; Thoracoscopic Lobectomy; Acute Postoperative Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group I（Age < 65 years old)

We will use the sequential allocation designed by Dixon. Oxycodone will be administered intravenously 30min before the end of surgery. The initial oxycodone dose will be set to 0.1 mg/kg. A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point will be included as the first case for ED50 estimation in each group. The study will conducted until 7 crossover points have be collected .

Group Type: EXPERIMENTAL

Oxycodone will be administered intravenously in the group 1

Intervention Type: DRUG

Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study

Group II(Age ≥65 years old)

We will use the sequential allocation designed by Dixon. Oxycodone will be administered intravenously 30min before the end of surgery. The initial oxycodone dose will be set to 0.1 mg/kg. A satisfactory or an unsatisfactory analgesic response of the previous patient determined, respectively, the relative 10% decrease or increase in the dose of oxycodone the next patient received in the same group. The patient before the first crossover point will be included as the first case for ED50 estimation in each group. The study will conducted until 7 crossover points have be collected .

Group Type: EXPERIMENTAL

Oxycodone will be administered intravenously in the group 1

Intervention Type: DRUG

Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study

Interventions

Oxycodone will be administered intravenously in the group 1

Oxycodone will be administered intravenously 30min before the end of surgery, and Dixon sequential method will be used for the study

Intervention Type: DRUG

Other Intervention Names

They are grouped according to age

Eligibility Criteria

Inclusion Criteria

1. The first unilateral thoracoscopic lobectomy was performed under general anesthesia

2. age 18- 80 years old

3. American Society of Anesthesiologists (ASA) physical status I-III

4. Sign the informed consent of the patients

Exclusion Criteria

1. Moderate to severe obesity (i.e., BMI > 30kg/m2)

2. Allergic or hypersensitive reaction to oxycodon

3. A history of chronic pain

4. Patients with significant heart, pulmonary, liver or renal disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jianbo Wu

OTHER

Sponsor Role: lead

Responsible Party

Jianbo Wu

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Wu Jian bo, doctorate

Role: CONTACT

jianbowu@126.com

18560083793

Zhang min, master

Role: CONTACT

ZM18364183909@163.com

18364183909

References

Zhang M, Liu Y, Cao J, Liu M, Gao X, Guo N, Wei C, Zhu Y, Sun Y, Wu J. The median effective dose of oxycodone for acute postoperative pain after thoracoscopic pulmonary surgery with intercostal nerve blockin in patients of different ages: a dose-finding study protocol. BMC Anesthesiol. 2025 Jul 1;25(1):323. doi: 10.1186/s12871-025-03198-5.

Reference Type: DERIVED

PMID: 40597587 (View on PubMed)

Other Identifiers

YXLL-KY-2024(058)

Identifier Type: -

Identifier Source: org_study_id