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

Tianjin Medical University General Hospital164 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

164

Conditions

Postoperative Pain

Interventions

Normal salineDRUG

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

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 lidocaine at low concentrationDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject is scheduled to undergo gynecological laparotomy 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.

Locations (1)

Tianjin Medical University General Hospital

Tianjin, China

Outcomes

Primary Outcomes

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.

Time frame: 72 hours after surgery

Secondary Outcomes

Time of First Postoperative Analgesic Requirement

First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.

Time frame: 1 hour after surgery

Total Dose of First Postoperative Analgesic Requirement

First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.

Time frame: 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

Time frame: 72 hours after surgery

Occurrence of Side Effects

Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus

Time frame: 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.

Data from ClinicalTrials.gov

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