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

Study Overview
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Brief Summary
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Purpose: To explore effects of ultrasound-guided transversus abdominis plane block with compound lidocaine on postoperative pain after gynecological laparotomy.

Detailed Description
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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 open sugery lacks investigations. Herein, we will evaluate the efficacy of ultrasound-guided transversus abdominis plane (USG-TAP) block with compound lidocaine injection for postoperative analgesia in patients undergoing gynecological laparotomy.

Official Title
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Effect of Ultrasound-guided Transversus Abdominis Plane Block With Compound Lidocaine on Postoperative Pain in Patients Undergoing Gynecological Laparotomy：a Randomized Double-blind Controlled Trial

Conditions
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Postoperative Pain

Intervention / Treatment
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* Drug: Normal saline
* Drug: Ropivacaine
* Drug: Compound lidocaine at low concentration
* Drug: Compound lidocaine at high concentration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is scheduled to undergo gynecological laparotomy 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline in transversus abdominis plane block<br>Before 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<br>* Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: 0. 9% Sodium Chloride Injection;|
| Active Comparator: Ropivacaine in transversus abdominis plane block<br>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 | Drug: Ropivacaine<br>* 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<br>* Other names: Ropivacaine Hydrochloride Injection;|
| Active Comparator: Compound lidocaine at low-concentration in transversus abdominis plane block<br>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 | Drug: Compound lidocaine at low concentration<br>* 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<br>* Other names: Compound Hydrochloride Lidocaine Injection;|
| Active Comparator: Compound lidocaine at high-concentration in transversus abdominis plane block<br>Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side | Drug: Compound lidocaine at high concentration<br>* Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side<br>* Other names: Compound Hydrochloride Lidocaine Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of First Postoperative Analgesic Requirement | First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl. | 1 hour after surgery | 
| Total Dose of First Postoperative Analgesic Requirement | First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl. | 1 hour after surgery | 
| Cumulative Sufentanyl Consumption | Each patient was administered analgesics using a PCA (Patient-controlled analgesia) pump containing sufentanil (200μg) in normal saline at a total volume of 200 ml after leaving PACU (Postanesthesia care unit). This device was set to deliver a basal infusion of 2 ml/h and bolus doses of 0.5 ml with a 15-min lockout period. Sufentanyl cumulative consumption is recorded 72 hours postoperatively | 72 hours after surgery | 
| Occurrence of Side Effects | Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus | 72 hours after surgery | 
| 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. | 72 hours after surgery | 
| The onset time of sensory block | Sensory block was assessed using a cold test (2 = normal sensation, 1 = decreased cold sensation compared, 0 = loss of cold sensation) on the bilateral anterior abdomen between the median line and linea semiluminaris from T7-T12. The sensation was compared with the sensation to cold at ipsilateral lateral thoracic region of T4-T5. | 30 minutes after transversus abdominis plane block | 
| 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 . | 30 minutes after transversus abdominis plane block | 
| Apfel score | The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV). | The day before the surgery | 
| Mean time until passage of flatus | Gastrointestinal motility was evaluated by recording mean time until passage of flatus | 72 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Compound lidocaine, Ropivacaine, pain intensity, Transversus abdominis plane block