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Effect of Transversus Abdominis Plane Block With Compound Lidocaine and Esketamine on Pain After Surgery

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05122338
Enrollment
160
Registered
2021-11-16
Start date
2021-12-01
Completion date
2022-06-15
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

Keywords

Compound lidocaine, Ropivacaine, Transversus abdominis plane block, opioid consumption

Brief summary

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.

Interventions

DRUGNormal saline

Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side

DRUGRopivacaine

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

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

DRUGEsketamine

Before the induction of anesthesia, 0.4mg/kg esketamine is used for bilateral transversus abdominis plane block

Sponsors

Tianjin Medical University General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Subject is scheduled to undergo colorectal cancer surgery under general anesthesia 2. Subject's American Society of Anesthesiologists physical status is I-II. 3. The subject's parent/legally authorized guardian has given written informed consent to participate.

Exclusion criteria

1. Subject has a diagnosis of bronchial asthma, coronary heart disease, severe hypertension, renal failure or liver failure. 2. Subject has a diagnosis of Insulin dependent diabetes. 3. Subject is allergy and contraindication to local anesthetics or any components of local anesthetics. 4. 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. 5. Subject has any contraindication for the use of patient-controlled analgesia (PCA). 6. Subject is pregnant or breast-feeding. 7. Subject is obese (body mass index \>30kg/m\^2). 8. Subject is incapacity to comprehend pain assessment and cognitive assessment.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative opioid consumption48 hours after surgeryEach 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.

Secondary

MeasureTime frameDescription
Pain Score (NRS)48 hours after surgeryThe pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Total Dose of First Postoperative Analgesic Requirement1 hour after surgeryFirst postoperative pain (NRS≥5) is initially controlled by titration of opioid.
The incidence of Side Effects48 hours after surgeryThe number of patients with side effects including nausea, vomiting, dizziness, headache, shivering, and pruritus is recorded for 48 hours postoperatively.
Apfel scoreThe 1 day before the surgeryThe Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Time of First Postoperative Analgesic Requirement1 hour after surgeryFirst postoperative pain (NRS≥5) is initially controlled by titration of opioid.
Diffusion area of local anesthetics after transversus abdominis plane block30 minutes after transversus abdominis plane blockDiffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance.
Normalized Area of Hyperalgesia Around the Incision48 hours after surgeryThe 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.
The level of cytokines in blood By ELISA kits48 hours after surgeryBlood is collected to measure the level of cytokines (such as IL-18, IL-17, IL-23 ) using ELISA kits.
The level of chemokines in blood By ELISA kits48 hours after surgeryBlood is collected to measure the level of chemokines (such as CXCL1, CCL7, CCL2) using ELISA kits.
Mean time until passage of flatus96 hours after surgeryGastrointestinal motility was evaluated by recording mean time until passage of flatus

Contacts

Primary ContactGuolin Wang, MD
wangguolinghad@hotmail.com+8615822855556

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026