Postoperative PainNCT05964985
Effect of Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Pain After Colorectal 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 quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal 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
- 6 Aug 2023to 15 Feb 2024
- 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-III.
- 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 Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial
Purpose:
To explore effects of ultrasound-guided quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.
Read the detailed description
Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis 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 quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal surgery.
- Conditions
- Postoperative Pain
- Being tested
- Normal saline, Ropivacaine, Compound lidocaine, Esketamine
- Keywords
- Compound lidocaine, Esketamine, Quadratus lumborum 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
After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
RopivacaineDrug
Also called Ropivacaine Hydrochloride Injection
After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
Compound lidocaineDrug
Also called Compound Lidocaine Hydrochloride Injection
After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side
EsketamineDrug
Also called Esketamine injection
After the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block
| Study group | Role | What they receive |
|---|---|---|
| Normal saline in quadratus lumborum block | Placebo comparator | After the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. Receives: Drug: Normal saline |
| Ropivacaine in quadratus lumborum block | Active comparator | After the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. Receives: Drug: Ropivacaine |
| Compound lidocaine in quadratus lumborum block | Active comparator | After the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. Receives: Drug: Compound lidocaine |
| Compound lidocaine and esketamine in quadratus lumborum block | Active comparator | After the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum 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 72 hours postoperatively.
Measured: 72 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: 72 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 72 hours postoperatively.
Measured: 72 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 quadratus lumborum block
Diffusion area of local anesthetics after quadratus lumborum block was calculated under ultrasound assistance.
Measured: 30 minutes after quadratus lumborum 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: 72 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: 72 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: 72 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 posted28 Jul 2023
- Study start6 Aug 2023 (estimated)
- Primary completion15 Jan 2024 (estimated)
- Study completion15 Feb 2024 (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, MD, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964985
- Sponsor's protocol ID
- GWang023
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 28 Jul 2023
- 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 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound-guided Quadratus Lumborum Block With Compound Lidocaine and Esketamine on Postoperative Pain in Patients Undergoing Colorectal Surgery: a Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT05964985
- Acronym / sponsor ID
- GWang023
- Conditions
- Postoperative Pain
- Keywords
- Compound lidocaine, Esketamine, Quadratus lumborum 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
- 6 Aug 2023 (estimated)
- Primary completion
- 15 Jan 2024 (estimated)
- Study completion
- 15 Feb 2024 (estimated)
- First posted
- 28 Jul 2023 (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 quadratus lumborum block with compound lidocaine and esketamine on postoperative pain after colorectal surgery.
Detailed description
Poor post-surgical pain control is a leading factor that hinders the physicalrehabilitation, and causes acute cognitive impairment and chronic painsyndrome. Recently, the multimodal analgesia strategies to minimise opioidrelated side effects are highly desirable in open surgical procedures. Quadratus lumborum block is a novel technique. Although ropivacaine is most commonly used forthis 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 quadratus lumborum block for abdominal surgery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided quadratus lumborum block (USG-QLB) with compound lidocaine injection and esketamine for postoperative analgesia in patients undergoing colorectal 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 quadratus lumborum block | Placebo comparator | Drug: Normal salineAfter the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. |
| Ropivacaine in quadratus lumborum block | Active comparator | Drug: RopivacaineAfter the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. |
| Compound lidocaine in quadratus lumborum block | Active comparator | Drug: Compound lidocaineAfter the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side. |
| Compound lidocaine and esketamine in quadratus lumborum block | Active comparator | Drug: Compound lidocaine, Drug: EsketamineAfter the induction of anesthesia, 0.6% compound lidocaine and 0.4 mg/kg esketamine are used for bilateral quadratus lumborum 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-III.
- 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 InjectionAfter the induction of anesthesia, normal saline is used for bilateral quadratus lumborum block in a volume of 20 mL of each side | Drug | Normal saline in quadratus lumborum block |
| RopivacaineAlso: Ropivacaine Hydrochloride InjectionAfter the induction of anesthesia, 0.375% ropivacaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side | Drug | Ropivacaine in quadratus lumborum block |
| Compound lidocaineAlso: Compound Lidocaine Hydrochloride InjectionAfter the induction of anesthesia, 0.6% compound lidocaine is used for bilateral quadratus lumborum block in a volume of 20 mL of each side | Drug | Compound lidocaine and esketamine in quadratus lumborum block, Compound lidocaine in quadratus lumborum block |
| EsketamineAlso: Esketamine injectionAfter the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral quadratus lumborum block | Drug | Compound lidocaine and esketamine in quadratus lumborum block |
Primary outcome
Postoperative opioid consumption
Time frame: 72 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 72 hours postoperatively.
10 secondary outcomes
Pain Score (NRS)
Time frame: 72 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: 72 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 quadratus lumborum block
Time frame: 30 minutes after quadratus lumborum block
Normalized Area of Hyperalgesia Around the Incision
Time frame: 72 hours after surgery
The level of cytokines in blood By ELISA kits
Time frame: 72 hours after surgery
The level of chemokines in blood By ELISA kits
Time frame: 72 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 28 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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, MD 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 28 Jul 2023. 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 (+86 15822855556, 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: 72 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 28 Jul 2023.