Colon CancerNCT04147481
Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
A study testing Group Abdominal Nerve Block with local anesthetics and Group Abdominal Nerve Block with saline in people with Colon Cancer and Rectal Cancer, run by Yi Liu at 1 site in China.
Trial summary
To explore the effect of general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) on the recovery of patients with gastrointestinal tumor after surgical treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Rectal Cancer, Gastric Cancer
- What is being tested?
- Group Abdominal Nerve Block with local anesthetics and Group Abdominal Nerve Block with saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years.
- ASA 1-3.
- Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
- Surgery for gastrointestinal surgery.
Who cannot join
- Patients and their family members refuse to accept the clinical trial;
- Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
- Hepatic encephalopathy, psychosis or neuropathy;
- Body weight for acid-base and electrolyte imbalances, endotoxemia, and cachexia decreased by more than 2% or 5% in the past 2 months or 6 months.
- Uncontrolled hypertentsion, coronary heart disease, diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
To explore the effect of general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) on the recovery of patients with gastrointestinal tumor after surgical treatment.
- Conditions
- Colon Cancer, Rectal Cancer, Gastric Cancer
- Being tested
- Group Abdominal Nerve Block with local anesthetics, Group Abdominal Nerve Block with saline
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Abdominal Nerve Block with local anestheticsOther
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
Group Abdominal Nerve Block with salineOther
surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with not 0.2% ropivacaine but 0.9% saline.
| Study group | Role | What they receive |
|---|---|---|
| Group Abdominal Nerve Block | Experimental | surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine Receives: Other: Group Abdominal Nerve Block with local anesthetics |
| Group control | Placebo comparator | surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline. Receives: Other: Group Abdominal Nerve Block with saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative chronic pain
The incidence of chronic pain 6 month after operation
Measured: 6 month after operation
Secondary outcomes (3)
Bedridden time
Postoperative bedridden time
Measured: The postoperative duration up to 15 days
Fasting time
Postoperative fasting time
Measured: The postoperative duration up to 15 days
Gastrointestinal decompression
Time of gastrointestinal decompression
Measured: The postoperative duration up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2019
- Study start21 Oct 2019
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies 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
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Liu, Chinese PLA General Hospital
- Investigators
- Yi Liu, MD, Study chair, the Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04147481
- Sponsor's protocol ID
- PLAGHAOC1901
- Status last verified
- Nov 2019
- First submitted
- 19 Oct 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT04147481
- Acronym / sponsor ID
- PLAGHAOC1901
- Conditions
- Colon Cancer, Rectal Cancer, Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yi LiuUniversity, hospital or other
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 1 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore the effect of general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) on the recovery of patients with gastrointestinal tumor after surgical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Abdominal Nerve Block | Experimental | Other: Group Abdominal Nerve Block with local anestheticssurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine |
| Group control | Placebo comparator | Other: Group Abdominal Nerve Block with salinesurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.9% saline. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 to 80 years.
- ASA 1-3.
- Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
- Surgery for gastrointestinal surgery.
Key exclusion criteria (5 listed)
- Patients and their family members refuse to accept the clinical trial;
- Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
- Hepatic encephalopathy, psychosis or neuropathy;
- Body weight for acid-base and electrolyte imbalances, endotoxemia, and cachexia decreased by more than 2% or 5% in the past 2 months or 6 months.
- Uncontrolled hypertentsion, coronary heart disease, diabetes.
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 |
|---|---|---|
| Group Abdominal Nerve Block with local anestheticssurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine | Other | Group Abdominal Nerve Block |
| Group Abdominal Nerve Block with salinesurgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with not 0.2% ropivacaine but 0.9% saline. | Other | Group control |
Primary outcome
Incidence of postoperative chronic pain
Time frame: 6 month after operation
The incidence of chronic pain 6 month after operation
3 secondary outcomes
Bedridden time
Time frame: The postoperative duration up to 15 days
Fasting time
Time frame: The postoperative duration up to 15 days
Gastrointestinal decompression
Time frame: The postoperative duration up to 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
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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.
Yi Liu, MD study chair
the Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Abdominal Nerve Block with local anesthetics and Group Abdominal Nerve Block with saline in people with Colon Cancer and Rectal Cancer, run by Yi Liu 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Nov 2019. 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?
Results are not available in the source record.
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?
Incidence of postoperative chronic pain (time frame: 6 month after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2019.