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
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	Nil known
Sponsor	General Hospital of Southern Theatre Command of PLA
Funder	Natural Science Foundation of Guangdong Province

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mrs Zhaoju Li
Public

Department of Anesthesiology
General Hospital of Southern Theatre Command of PLA
111 Liuhua Road
Yuexiu District
Guangzhou
510000
China

Phone	+86 15602405803
Email	wftuyx02@163.com

Study information

Primary study design	Observational
Study design	Single-center retrospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ropivacaine, sufentanil, dexmedetomidine, haloperidol
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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)
Completion date	01/12/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

The Southern Theater General Hospital of the Chinese People's Liberation Army

Department of Anesthesiology
General Hospital of Southern Theatre Command of PLA
111 Liuhua Road
Yuexiu District
Guangzhou
510000
China

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
IPD sharing plan	All data generated or analysed during this study will be included in the subsequent results publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/10/2021: Trial's existence confirmed by Natural Science Foundation of Guangdong Province.