Clinical trial NCT04938882: Effect of Transversus Abdominis Plane Block With Compound Lidocaine on Pain After Gynecological Surgery
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: Compound lidocaine
Ropivacaine
pain intensity
Transversus abdominis plane block
Lead sponsor: Tianjin Medical University General Hospital
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 164
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Score (NRS)
timeFrame: 72 hours after surgery
Secondary outcomes:
measure: Time of First Postoperative Analgesic Requirement
timeFrame: 1 hour after surgery
measure: Total Dose of First Postoperative Analgesic Requirement
timeFrame: 1 hour after surgery
measure: Cumulative Sufentanyl Consumption
timeFrame: 72 hours after surgery
measure: Occurrence of Side Effects
timeFrame: 72 hours after surgery
measure: Normalized Area of Hyperalgesia Around the Incision
timeFrame: 72 hours after surgery
measure: The onset time of sensory block
timeFrame: 30 minutes after transversus abdominis plane block
measure: Diffusion area of local anesthetics after transversus abdominis plane block
timeFrame: 30 minutes after transversus abdominis plane block
measure: Apfel score
timeFrame: The day before the surgery
measure: Mean time until passage of flatus
timeFrame: 72 hours after surgery
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
Study officials:
affiliation: Tianjin Medical University General Hospital
name: Guolin Wang, MD
role: STUDY_DIRECTOR
References:
citation: Tran DQ, Bravo D, Leurcharusmee P, Neal JM. Transversus Abdominis Plane Block: A Narrative Review. Anesthesiology. 2019 Nov;131(5):1166-1190. doi: 10.1097/ALN.0000000000002842.
citation: Ma N, Duncan JK, Scarfe AJ, Schuhmann S, Cameron AL. Clinical safety and effectiveness of transversus abdominis plane (TAP) block in post-operative analgesia: a systematic review and meta-analysis. J Anesth. 2017 Jun;31(3):432-452. doi: 10.1007/s00540-017-2323-5. Epub 2017 Mar 7.