GastrostomyNCT03035916

Transversus Abdominis Plane Block on Stress Response

A study testing Transversus abdominis plane block and Epidural anesthesia in people with Gastrostomy, run by Jilin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Gastrostomy
What is being tested?: Transversus abdominis plane block and Epidural anesthesia
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 91 participants
Where: 1 siteChina
Study dates: 20 Jan 2017to 15 Jul 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Consent
ASA 1-3
No contraindication to epidural or ropivacaine
First time surgery for current conditions
Not on chronic pain medications or sedative

Who cannot join

The subject has a known or suspected allergy to opioid analgesics or ropivacaine
Emergency patients
The subject has know central nervous system disease or neurological impairment
The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.

Trial locations and contacts

1 site in 1 country.

China1 site

China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130000

Other trials in China

About this study

Official title: Effect of Transversus Abdominis Plane Block Combined With General Anesthesia on Perioperative Stress Response in Patients Undergoing Radical Gastrectomy: A Double-blind Randomized Controlled Study.

This study evaluates the effect of transversus abdominis plane(TAP) block combined with general anesthesia on perioperative stress response in patients undergoing radical gastrectomy. One third of participants will receive TAP block combined with general anesthesia, another one third of participants will receive epidural anesthesia combined with general anesthesia, while the rest will receive only general anesthesia.

Read the detailed description

Clinically, combining epidural with general anaesthesia may confer many advantages to patients undergoing major thoracic, abdominal or orthopaedic surgery. Epidural anaesthesia can attenuate sympathetic hyperactivity and the stress response, maintain bowel peristalsis, spare the use of opioids, and facilitate postoperative feeding and physiotherapy. However, establishing epidural anesthesia is not without risks and contraindications, including refusal by the patient, technical failure, unintentional dural puncture, waist and back pain and local anaesthetic toxicity. When neurologic complications do occur, the resulting morbidity and mortality is considerable. Transversus abdominis plane (TAP) block, is another new regional anesthesia technique, has been introduced as an abdominal wall block capable of providing effective analgesia, reducing opioid consumption, and lessening opioid-related side effects. In addition,TAP block, somewhat as a pre-emptive analgesia approach, is a way of pain intervention before noxious stimulation which has been reported to be potent to attenuate the stress response. Although the analgesia efficiency of TAP block has been widely studied, its effectiveness to suppress stress response has little comparison with classic epidural block and general anesthesia. Unlike epidural anaesthesia, TAP block is easy to administer and lower incidence for side-effects.The investigators hypothesize that the TAP block reduces the stress response of surgery to the similar extent to epidural anaesthesia when combined with a standard general anaesthesia for abdominal surgery.

Conditions: Gastrostomy
Being tested: Transversus abdominis plane block, Epidural anesthesia, control
Keywords: transversus abdominal plane block, epidural anesthesia, stress response, anesthetic recovery
Medical subject headings: Fractures, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transversus abdominis plane blockOther
Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
Epidural anesthesiaOther
Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
controlOther
The Control group receives standard IV-inhaled general anesthesia.

Study groups in NCT03035916
Study group	Role	What they receive
Transversus abdominis plane block	Experimental	The TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia. Receives: Other: Transversus abdominis plane block
Epidural anesthesia	Active comparator	The Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery. Receives: Other: Epidural anesthesia
Control	Placebo comparator	The Control group receives standard IV-inhaled general anesthesia. Receives: Other: control

What is being measured

The primary outcome is the main question the study is designed to answer.

Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Measured: up to 48h after surgery
Physiological Parameters: Plasma Concentration of Epinephrine (E)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.
Measured: up to 48h after surgery
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.
Measured: up to 48h after surgery
Physiological Parameters: Plasma Concentration of Glucose (Glu)
When venous blood are collected, glucose levels are measured immediately by Glucometer.
Measured: up to 48h after surgery
Hemodynamic Parameters: Heart Rate.
Continuous monitoring of heart rate to 48 hours after surgery.
Measured: up to 48h after surgery
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3
Measured: up to 48h after surgery

Secondary outcomes (8)

Anesthetics Consumption: Sufentanil Consumption
Intraoperative superaddition of sufentanil was measured.
Measured: during operation
Questionnaire: Pain Scores at Rest
Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Measured: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Questionnaire: Pain Scores on Movement
Pain scores of the participants will be measured by the Visual Analogue Scale. Measurement of VAS: Draw a 10cm horizontal line on the paper. The VAS were anchored at 0cm(no pain) and 10cm(worst possible pain), the middle part shows varying degrees of pain, the greater of the number, the worse of the pain.
Measured: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Anesthesia Recovery: the Time of First Flatus
The time of first flatus was measured after surgery.
Measured: Through study completion, an average of 2 weeks
Anesthesia Recovery: Number of Participants With Prolonged Hospitalization
The percentage of long hospitalization were measured. More than 7 days after surgery is defined as prolonged hospitalization.
Measured: Through study completion, an average of 2 weeks
Side Effects: Number of Participants With Sedation
The state of sedation was evaluated after surgery during first postoperative 48 hours.
Measured: up to 48h after surgery
Side Effects: Number of Participants With Nausea
The state of nausea was evaluated after surgery during first postoperative 48 hours.
Measured: up to 48h after surgery
Side Effects: Number of Participants With Vomiting
The state of vomiting was evaluated after surgery during first postoperative 48 hours.
Measured: up to 48h after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jan 201715 Jul 2017

First posted30 Jan 2017 (estimated)
Study start20 Jan 2017
Primary completion31 May 2017
Study completion15 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GastrostomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03035916
Sponsor's protocol ID: 3D5l4L463430
Other IDs: 3R210Z893430
Status last verified: Dec 2017
First submitted: 13 Jan 2017
Last updated: 23 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastrostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Transversus Abdominis Plane Block Combined With General Anesthesia on Perioperative Stress Response in Patients Undergoing Radical Gastrectomy: A Double-blind Randomized Controlled Study.
ClinicalTrials.gov ID: NCT03035916
Acronym / sponsor ID: 3D5l4L463430
Conditions: Gastrostomy
Keywords: transversus abdominal plane block, epidural anesthesia, stress response, anesthetic recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Jilin UniversityUniversity, hospital or other
Study start: 20 Jan 2017 (actual)
Primary completion: 31 May 2017 (actual)
Study completion: 15 Jul 2017 (actual)
First posted: 30 Jan 2017 (estimated)
Results: Posted 15 Dec 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Transversus abdominis plane block	Experimental	Other: Transversus abdominis plane blockThe TAP group receives ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia.
Epidural anesthesia	Active comparator	Other: Epidural anesthesiaThe Epidural group receives epidural block (T8-9) 2 mL of 1.6% lidocaine as a test dose and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
Control	Placebo comparator	Other: controlThe Control group receives standard IV-inhaled general anesthesia.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Consent
ASA 1-3
No contraindication to epidural or ropivacaine
First time surgery for current conditions
Not on chronic pain medications or sedative

Key exclusion criteria (4 listed)

The subject has a known or suspected allergy to opioid analgesics or ropivacaine
Emergency patients
The subject has know central nervous system disease or neurological impairment
The subject has preoperative infection, and a history of immune and endocrine system disease, chemotherapy, or blood transfusion.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transversus abdominis plane blockParticipants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.	Other	Transversus abdominis plane block
Epidural anesthesiaParticipants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.	Other	Epidural anesthesia
controlThe Control group receives standard IV-inhaled general anesthesia.	Other	Control

Primary outcome

Physiological Parameters: Plasma Concentration of Norepinephrine (NE)
Time frame: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The NE levels are measured by ELISA kits.
Physiological Parameters: Plasma Concentration of Epinephrine (E)
Time frame: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The E levels are measured by ELISA kits.
Physiological Parameters: Plasma Concentration of Cortisol (Cor)
Time frame: up to 48h after surgery
Venous blood samples will be collected at certain time points. The blood samples are collected in a pre-chilled tubes in ice and are centrifuged within 90min, and then separated plasma are stored at -80°C until analysis. The Cor levels are measured by ELISA kits.
Physiological Parameters: Plasma Concentration of Glucose (Glu)
Time frame: up to 48h after surgery
When venous blood are collected, glucose levels are measured immediately by Glucometer.
Hemodynamic Parameters: Heart Rate.
Time frame: up to 48h after surgery
Continuous monitoring of heart rate to 48 hours after surgery.
Hemodynamic Parameters: Mean Arterial Pressure(MAP)
Time frame: up to 48h after surgery
Continuous monitoring of mean arterial pressure(MAP) to 48 hours after surgery. mean arterial pressure(MAP)＝ (systolic blood pressure＋2×diastolic blood pressure)/3

8 secondary outcomes

Anesthetics Consumption: Sufentanil Consumption
Time frame: during operation
Questionnaire: Pain Scores at Rest
Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Questionnaire: Pain Scores on Movement
Time frame: 1hr, 6hr, 12hr, 24hr, and 48hr after surgery
Anesthesia Recovery: the Time of First Flatus
Time frame: Through study completion, an average of 2 weeks
Anesthesia Recovery: Number of Participants With Prolonged Hospitalization
Time frame: Through study completion, an average of 2 weeks
Side Effects: Number of Participants With Sedation
Time frame: up to 48h after surgery
Side Effects: Number of Participants With Nausea
Time frame: up to 48h after surgery
Side Effects: Number of Participants With Vomiting
Time frame: up to 48h after surgery

Results and safety

Results posted to the registry on 15 Dec 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Transversus Abdominis Plane Block	30	30
Epidural Anesthesia	30	28
Control	31	31

Primary outcome: Physiological Parameters: Plasma Concentration of Norepinephrine (NE)

Time frame: up to 48h after surgery. Mean (Standard Deviation). Unit: pg/ml

Measure	Transversus Abdominis Plane Block n = 30	Epidural Anesthesia n = 28	Control n = 31
Baseline	145.6 (25.8)	150.9 (33.2)	153.1 (35.2)
0 hr after surgery	170.2 (33.4)	165.5 (36.6)	177.9 (43.2)
6 hr after surgery	172.3 (32.7)	163.2 (32.4)	215.5 (50.3)
24 hr after surgery	150.5 (30.9)	155.8 (25.3)	175.4 (40.2)
48 hr after surgery	135.7 (29.8)	140.6 (24.8)	165.2 (32.7)

Transversus Abdominis Plane Block vs Epidural Anesthesia: p = 0.454, t-test, 2 sided
Transversus Abdominis Plane Block vs Control: p = 0.402, t-test, 2 sided
Epidural Anesthesia vs Control: p = 0.901, t-test, 2 sided

Primary outcome: Physiological Parameters: Plasma Concentration of Epinephrine (E)

Time frame: up to 48h after surgery. Mean (Standard Deviation). Unit: pg/ml

Measure	Transversus Abdominis Plane Block n = 30	Epidural Anesthesia n = 28	Control n = 31
Baseline	33.2 (6)	35 (5.4)	34.4 (6.1)
0 hr after surgery	41.5 (6.6)	40.5 (7.2)	42.2 (7)
6 hr after surgery	45.3 (8.2)	46.4 (7.5)	52.3 (8.1)
24 hr after surgery	44.5 (7)	41.8 (6.2)	59.1 (8.5)
48 hr after surgery	40.6 (6.3)	39.3 (5.2)	48.7 (7.6)

Transversus Abdominis Plane Block vs Epidural Anesthesia: p = 0.412, t-test, 2 sided
Transversus Abdominis Plane Block vs Control: p = 0.592, t-test, 2 sided
Epidural Anesthesia vs Control: p = 0.796, t-test, 2 sided

Primary outcome: Physiological Parameters: Plasma Concentration of Cortisol (Cor)

Time frame: up to 48h after surgery. Mean (Standard Deviation). Unit: mmol/L

Measure	Transversus Abdominis Plane Block n = 30	Epidural Anesthesia n = 28	Control n = 31
Baseline	273.3 (93)	262.4 (101.5)	286.3 (106.6)
0 hr after surgery	430.4 (152.1)	395.2 (133.4)	516.1 (162.3)
6 hr after surgery	519.2 (156.6)	464.2 (155.8)	698.3 (188.1)
24 hr after surgery	439 (116)	388.1 (121.2)	713.8 (190)
48 hr after surgery	320.6 (112.3)	302.8 (112.4)	452.4 (165.3)

Transversus Abdominis Plane Block vs Epidural Anesthesia: p = 0.673, t-test, 2 sided
Transversus Abdominis Plane Block vs Control: p = 0.824, t-test, 2 sided
Epidural Anesthesia vs Control: p = 0.547, t-test, 2 sided

Primary outcome: Physiological Parameters: Plasma Concentration of Glucose (Glu)

Time frame: up to 48h after surgery. Mean (Standard Deviation). Unit: mmol/L

Measure	Transversus Abdominis Plane Block n = 30	Epidural Anesthesia n = 28	Control n = 31
Baseline	5 (0.5)	5.2 (0.5)	5.5 (0.4)
0 hr after surgery	8.2 (1.2)	7.7 (0.9)	10.5 (1.5)
6 hr after surgery	7.5 (1)	7 (0.9)	10.8 (1.9)
24 hr after surgery	6.5 (0.8)	6.3 (0.7)	8.6 (1.5)
48 hr after surgery	5.5 (0.4)	5.2 (0.5)	5.8 (0.6)

Transversus Abdominis Plane Block vs Epidural Anesthesia: p = 0.249, t-test, 2 sided
Transversus Abdominis Plane Block vs Control: p = 0.091, t-test, 2 sided
Epidural Anesthesia vs Control: p = 0.493, t-test, 2 sided

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Transversus Abdominis Plane Block	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Epidural Anesthesia	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28
Control	0 of 31 (0%)	0 of 31 (0%)	0 of 31

Limitations and caveats (from the sponsor): Firstly, early termination leading to small numbers of subjects analyzed. Secondly, sufentanil for analgesia, known to have effects on neuroimmunoendocrine network, which may have influenced our finding.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Guoqing Zhao, doctor principal investigator

Jilin University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transversus abdominis plane block and Epidural anesthesia in people with Gastrostomy, run by Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physiological Parameters: Plasma Concentration of Norepinephrine (NE) (time frame: up to 48h after surgery). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03035916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.