Skip to main content
OpenTrials
Completed

NCT Number: NCT04938882

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

Purpose:

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin Medical University General Hospital

Tianjin, 300052, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

normal saline

Drug

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

Other names: 0. 9% Sodium Chloride Injection

Ropivacaine

Drug

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

Other names: Ropivacaine Hydrochloride Injection

Compound lidocaine at low concentration

Drug

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

Other names: Compound Hydrochloride Lidocaine Injection

Compound lidocaine at high concentration

Drug

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

Other names: Compound Hydrochloride Lidocaine Injection

Primary outcomes

  1. Pain Score (NRS)

    Time frame: 72 hours after surgery

    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.

Secondary outcomes

  1. Time of First Postoperative Analgesic Requirement

    Time frame: 1 hour after surgery

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

  2. Total Dose of First Postoperative Analgesic Requirement

    Time frame: 1 hour after surgery

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

  3. Cumulative Sufentanyl Consumption

    Time frame: 72 hours after surgery

    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

  4. Occurrence of Side Effects

    Time frame: 72 hours after surgery

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

  5. Normalized Area of Hyperalgesia Around the Incision

    Time frame: 72 hours after surgery

    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.

  6. The onset time of sensory block

    Time frame: 30 minutes after transversus abdominis plane 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.

  7. Diffusion area of local anesthetics after transversus abdominis plane block

    Time frame: 30 minutes after transversus abdominis plane block

    Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance .

  8. Apfel score

    Time frame: The day before the surgery

    The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).

  9. Mean time until passage of flatus

    Time frame: 72 hours after surgery

    Gastrointestinal motility was evaluated by recording mean time until passage of flatus

Sponsors and collaborators

Lead sponsor

Tianjin Medical University General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2021
Registry last updated
Feb 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.