Effect of epidural anesthesia on the quality of short-term rehabilitation in hospital after surgery for cancer
| ISRCTN | ISRCTN16446449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16446449 |
- Submission date
- 09/10/2021
- Registration date
- 26/10/2021
- Last edited
- 26/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Patients with cancer are often accompanied by a variety of diseases and internal milieu disturbance, surgical resection is still confronted by many issues. Thoracic epidural anesthesia (TEA) (an injection in your back to stop you feeling pain in part of your body) and postoperative analgesia (pain medication) are often used in surgery to remove cancer. However, there are also some problems with the practical application of TEA, especially the difficulty of puncture and catheter detachment and displacement, which constitute the main factors affecting epidural analgesia that greatly compromise the patient’s satisfaction.
The aim of this study is to perform a retrospective study on the postoperative short-term rehabilitation quality of patients with cancer undergoing minimally invasive radical resection based on the TEA combined with general anesthesia in comparison with general anesthesia alone.
Who can participate?
Patients aged 18 to 80 years undergoing minimally invasive surgery for cancer under general anesthesia.
What does the study involve?
Patients undergoing minimally invasive surgery with cancer under general anesthesia were selected sequentially from our database. According to whether TEA was used in anesthesia, the patients were divided into two groups, namely the TEA group and the control group (general anesthesia alone). The general anesthesia regimen was identical for both groups. In the TEA group, ropivacaine was given before general anesthesia, and the same dose of medicament was supplied at an intraoperative interval of 2h to maintain the block level. The epidural catheter was removed after surgery. Both groups were subjected to patient-controlled intravenous analgesia (PCIA). We will analyze the patient's conditions during and after surgery.
What are the possible benefits and risks of participating?
The application of TEA in minimally invasive radical resection of cancer can significantly reduce the dosages of intraoperative anesthetic drugs and postoperative opioid drugs, which is beneficial to the postoperative recovery of patients.
Where is the study run from?
General Hospital of Southern Theatre Command of PLA (China)
When is the study starting and how long is it expected to run for?
February 2021 to December 2021
Who is funding the study?
Natural Science Foundation of Guangdong Province (China)
Who is the main contact?
Zhaoju Li, hellenanna@126.com
Contact information
Public
Department of Anesthesiology
General Hospital of Southern Theatre Command of PLA
111 Liuhua Road
Yuexiu District
Guangzhou
510000
China
| Phone | +86 15602405803 |
|---|---|
| wftuyx02@163.com |
Study information
| Study design | Single-center retrospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not applicable (retrospective study) |
| Scientific title | A retrospective study on the postoperative short-term rehabilitation quality of patients with cancer undergoing minimally invasive radical resection based on thoracic epidural anesthesia (TEA) combined with general anesthesia in comparison with general anesthesia alone |
| Study objectives | The application of TEA in minimally invasive radical resection of cancer can significantly reduce the dosages of intraoperative anesthetic drugs and postoperative opioid drugs, lower analgesia-related adverse reactions, which is beneficial to rehabilitation of patients after surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Effect of intraoperative thoracic epidural anesthesia on the quality of hospital short-term rehabilitation after minimally invasive radical resection of cancer |
| Intervention | Patients undergoing minimally invasive surgery with cancer under general anesthesia according to whether TEA was used in anesthesia, the patients were divided into two groups, namely the TEA group and the control group (general anesthesia alone). The general anesthesia regimen was identical for both groups. In the TEA group, 0.15% ropivacaine (0.05 mL/kg) was given before general anesthesia, and the same dose of medicament was supplied at an intraoperative interval of 2 h to maintain the block level. The epidural catheter was removed after surgery. Both groups were subjected to patient-controlled intravenous analgesia (PCIA) using sufentanil (3 μg/kg), dexmedetomidine (2.5 μg/kg), and 2.5 mg of haloperidol in 150 mL of normal saline 30 min before the end of the surgery. The continuous basal dose was 1mL/h, and the single-dose was 2.5 mL. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Ropivacaine, sufentanil, dexmedetomidine, haloperidol |
| Primary outcome measure | Measured using patient records: 1. Dosage of anesthesia and vasoactive drugs used throughout the procedure 2. Postoperative analgesic information, including the time of the first pressing (i.e., the time when the surgery is over), the consumption of analgesic drugs, and the resting and motorial analgesic scores (R-VAS and M-VAS) at 24, 48 and 72 h postoperatively |
| Secondary outcome measures | Measured using patient records: 1. Demographic information: sex, age, height and weight, smoking and drinking history, preoperative complication of cardiovascular disease, diabetes mellitus, before the operation 2. Duration of the operation (min) |
| Overall study start date | 01/02/2021 |
| Completion date | 01/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Total final enrolment | 100 |
| Key inclusion criteria | Patients aged 18 - 80 years undergoing minimally invasive surgery with cancer under general anesthesia |
| Key exclusion criteria | 1. Patients with abnormal blood coagulation indices through the laboratory examination 48 h before operation 2. Patients with the operation time exceeding 12 h 3. Patients with operative method changed to thoracotomy or laparotomy 4. Patients with exploratory thoracotomy or laparotomy within 48 h after the operation |
| Date of first enrolment | 01/01/2018 |
| Date of final enrolment | 01/01/2021 |
Locations
Countries of recruitment
- China
Study participating centre
General Hospital of Southern Theatre Command of PLA
111 Liuhua Road
Yuexiu District
Guangzhou
510000
China
Sponsor information
Hospital/treatment centre
111 Liuhua Road
Yuexiu District
Guangzhou
510000
China
| Phone | +86 15602405803 |
|---|---|
| hellenanna@126.com |
Funders
Funder type
Government
Government organisation / Local government
- Alternative name(s)
- Guangdong Provincial Natural Science Foundation, Natural Science Foundation of Guangdong, Guangdong Natural Science Foundation, Natural Science Fund of Guangdong Province, 廣東省自然科學基金
- Location
- China
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | A study is planned for publication in a medical journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
21/10/2021: Trial's existence confirmed by Natural Science Foundation of Guangdong Province.
