Postoperative PainNCT05122338
Effect of Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Pain After Surgery
A study testing Normal saline, Ropivacaine and Compound lidocaine in people with Postoperative Pain, run by Tianjin Medical University General Hospital.
Trial summary
Purpose: To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Normal saline, Ropivacaine and Compound lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 15 Jun 2022
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Who cannot join
- Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
- Subject is pregnant or breast-feeding.
- Subject is obese (body mass index >30kg/m^2).
- Subject is incapacity to comprehend pain assessment and cognitive assessment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Ultrasound-guided Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Cancer Surgery: a Randomized Double-blind Controlled Trial
Purpose:
To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.
Read the detailed description
Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal cancer surgery.
- Conditions
- Postoperative Pain
- Being tested
- Normal saline, Ropivacaine, Compound lidocaine, Esketamine
- Keywords
- Compound lidocaine, Ropivacaine, Transversus abdominis plane block, opioid consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called 0. 9% Sodium Chloride Injection
Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
RopivacaineDrug
Also called Ropivacaine Hydrochloride Injection
Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Compound lidocaineDrug
Also called Compound Lidocaine Hydrochloride Injection
Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
EsketamineDrug
Also called Esketamine injection
Before the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block
| Study group | Role | What they receive |
|---|---|---|
| Normal saline in transversus abdominis plane block | Placebo comparator | Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. Receives: Drug: Normal saline |
| Ropivacaine in transversus abdominis plane block | Active comparator | Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. Receives: Drug: Ropivacaine |
| Compound lidocaine in transversus abdominis plane block | Active comparator | Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. Receives: Drug: Compound lidocaine |
| Compound lidocaine and esketamine in transversus abdominis plane block | Active comparator | Before the induction of anesthesia, 0.4% compound lidocaine and 0.4mg/kg esketamine are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. Receives: Drug: Compound lidocaine; Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 48 hours postoperatively.
Measured: 48 hours after surgery
Secondary outcomes (10)
Pain Score (NRS)
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Measured: 48 hours after surgery
Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
Measured: 1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of opioid.
Measured: 1 hour after surgery
The incidence of Side Effects
The number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively.
Measured: 48 hours after surgery
Apfel score
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Measured: The 1 day before the surgery
Mean time until passage of flatus
Gastrointestinal motility was evaluated by recording mean time until passage of flatus
Measured: 96 hours after surgery
Diffusion area of local anesthetics after transversus abdominis plane block
Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
Measured: 30 minutes after transversus abdominis plane block
Normalized Area of Hyperalgesia Around the Incision
The skin around the incision is stimulated in steps of 5 mm at intervals of 1 s starting outside of the hyperalgesic area in the direction of the incision. The distance from the incision to the first point where a 'painful', 'sore' or 'sharper'feeling occurred is measured and noted. This measurement is repeated at predefined radial lines around the incision. To eliminate the variable length of incision, this length is subtracted from the longer diameter leaving four radial distances from the end and from the middle of the incision. The normalized area of hyperalgesia is calculated by summing up the areas of the remaining four triangles measured by and Von Frey filament.
Measured: 48 hours after surgery
The level of cytokines in blood By ELISA kits
Blood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
Measured: 48 hours after surgery
The level of chemokines in blood By ELISA kits
Blood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion15 May 2022 (estimated)
- Study completion15 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122338
- Sponsor's protocol ID
- GWang021
- Status last verified
- Nov 2021
- First submitted
- 7 Nov 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Cancer Surgery: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05122338
- Acronym / sponsor ID
- GWang021
- Conditions
- Postoperative Pain
- Keywords
- Compound lidocaine, Ropivacaine, Transversus abdominis plane block, opioid consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 15 May 2022 (estimated)
- Study completion
- 15 Jun 2022 (estimated)
- First posted
- 16 Nov 2021 (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.
Purpose:
To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine and esketamine on postoperative pain after colorectal cancer surgery.
Detailed description
Poor post-surgical pain control is a leading factor that hinders the physical rehabilitation, and causes acute cognitive impairment and chronic pain syndrome. Recently, the multimodal analgesia strategies to minimise opioid related side effects are highly desirable in open surgical procedures. The transversus abdominis plane block is a novel technique involving injection of local anaesthetic between the internal oblique and the transversus abdominis muscles of the abdominal wall. Although ropivacaine is most commonly used for this technique, the analgesic duration remains not dissatisfied. Compared with ropivacaine, compound lidocaine injection has a better and longer analgesic activity since it contains menthol and ethanol with appropriate concentrations. However, whether compound lidocaine injection is efficiency in the transversus abdominis plane block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal cancer surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal saline in transversus abdominis plane block | Placebo comparator | Drug: Normal salineBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. |
| Ropivacaine in transversus abdominis plane block | Active comparator | Drug: RopivacaineBefore the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. |
| Compound lidocaine in transversus abdominis plane block | Active comparator | Drug: Compound lidocaineBefore the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. |
| Compound lidocaine and esketamine in transversus abdominis plane block | Active comparator | Drug: Compound lidocaine, Drug: EsketamineBefore the induction of anesthesia, 0.4% compound lidocaine and 0.4mg/kg esketamine are used for bilateral transversus abdominis plane block in a volume of 20 mL of each side. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is scheduled to undergo colorectal cancer surgery under general anesthesia
- Subject's American Society of Anesthesiologists physical status is I-II.
- The subject's parent/legally authorized guardian has given written informed consent to participate.
Key exclusion criteria (8 listed)
- Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure.
- Subject has a diagnosis of Insulin dependent diabetes.
- Subject is allergy and contraindication to local anesthetics or any components of local anesthetics.
- Subject has a history of chronic pain, a history of alcohol or opioid abuse, pre- existing therapy with opioids, intake of any analgesic drug within 48 hours before surgery.
- Subject has any contraindication for the use of patient-controlled analgesia (PCA).
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 |
|---|---|---|
| Normal salineAlso: 0. 9% Sodium Chloride InjectionBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Normal saline in transversus abdominis plane block |
| RopivacaineAlso: Ropivacaine Hydrochloride InjectionBefore the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Ropivacaine in transversus abdominis plane block |
| Compound lidocaineAlso: Compound Lidocaine Hydrochloride InjectionBefore the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug | Compound lidocaine and esketamine in transversus abdominis plane block, Compound lidocaine in transversus abdominis plane block |
| EsketamineAlso: Esketamine injectionBefore the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block | Drug | Compound lidocaine and esketamine in transversus abdominis plane block |
Primary outcome
Postoperative opioid consumption
Time frame: 48 hours after surgery
Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing opioid in normal saline after leaving PACU (Postanesthesia care unit). Opioid cumulative consumption is recorded for 48 hours postoperatively.
10 secondary outcomes
Pain Score (NRS)
Time frame: 48 hours after surgery
Time of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
Total Dose of First Postoperative Analgesic Requirement
Time frame: 1 hour after surgery
The incidence of Side Effects
Time frame: 48 hours after surgery
Apfel score
Time frame: The 1 day before the surgery
Mean time until passage of flatus
Time frame: 96 hours after surgery
Diffusion area of local anesthetics after transversus abdominis plane block
Time frame: 30 minutes after transversus abdominis plane block
Normalized Area of Hyperalgesia Around the Incision
Time frame: 48 hours after surgery
The level of cytokines in blood By ELISA kits
Time frame: 48 hours after surgery
The level of chemokines in blood By ELISA kits
Time frame: 48 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- 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.
Guolin Wang study director
Tianjin Medical University General Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline, Ropivacaine and Compound lidocaine in people with Postoperative Pain, run by Tianjin Medical University General Hospital.
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 3 inclusion and 8 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 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Guolin Wang, MD (+8615822855556, wangguolinghad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative opioid consumption (time frame: 48 hours after surgery). 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 16 Nov 2021.