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Clinical Trials/NCT04938882
NCT04938882
Completed
N/A

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

Tianjin Medical University General Hospital1 site in 1 country164 target enrollmentAugust 15, 2021

Overview

Phase
N/A
Intervention
Normal saline
Conditions
Postoperative Pain
Sponsor
Tianjin Medical University General Hospital
Enrollment
164
Locations
1
Primary Endpoint
Pain Score (NRS)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Purpose:

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

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 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.

Registry
clinicaltrials.gov
Start Date
August 15, 2021
End Date
February 14, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guolin Wang

Professor

Tianjin Medical University General Hospital

Eligibility Criteria

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.

Arms & Interventions

Normal saline in transversus abdominis plane block

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

Intervention: Normal saline

Ropivacaine in transversus abdominis plane block

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

Intervention: Ropivacaine

Compound lidocaine at low-concentration in transversus abdominis plane block

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

Intervention: Compound lidocaine at low concentration

Compound lidocaine at high-concentration in transversus abdominis plane block

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

Intervention: Compound lidocaine at high concentration

Outcomes

Primary Outcomes

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

  • Cumulative Sufentanyl Consumption(72 hours after surgery)
  • Normalized Area of Hyperalgesia Around the Incision(72 hours after surgery)
  • Time of First Postoperative Analgesic Requirement(1 hour after surgery)
  • Total Dose of First Postoperative Analgesic Requirement(1 hour after surgery)
  • Occurrence of Side Effects(72 hours after surgery)
  • The onset time of sensory block(30 minutes after transversus abdominis plane block)
  • Diffusion area of local anesthetics after transversus abdominis plane block(30 minutes after transversus abdominis plane block)
  • Apfel score(The day before the surgery)
  • Mean time until passage of flatus(72 hours after surgery)

Study Sites (1)

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