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Postoperative PainNCT04938882

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

A study testing Normal saline, Ropivacaine and Compound lidocaine at low concentration in people with Postoperative Pain, run by Tianjin Medical University General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 60 years, women only
Conditions the study is for
Postoperative Pain
What is being tested?
Normal saline, Ropivacaine and Compound lidocaine at low concentration
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
164 participants
Where
1 siteChina
Study dates
15 Aug 2021to 14 Feb 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Medical University General Hospital

    Tianjin, 300052

Other trials in China

About this study

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

Purpose:

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

Read the 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.

Being tested
Normal saline, Ropivacaine, Compound lidocaine at low concentration, Compound lidocaine at high concentration
Keywords
Compound lidocaine, Ropivacaine, pain intensity, Transversus abdominis plane block
Medical subject headings
Pain, Postoperative, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Normal salineDrug

    Also called 0. 9% Sodium Chloride Injection

    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

    Also called Ropivacaine Hydrochloride Injection

    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

    Also called Compound Hydrochloride Lidocaine Injection

    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

  • Compound lidocaine at high concentrationDrug

    Also called Compound Hydrochloride Lidocaine Injection

    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

Study groups in NCT04938882
Study groupRoleWhat they receive
Normal saline in transversus abdominis plane blockPlacebo comparatorBefore the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Receives: Drug: Normal saline
Ropivacaine in transversus abdominis plane blockActive comparatorBefore the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Receives: Drug: Ropivacaine
Compound lidocaine at low-concentration in transversus abdominis plane blockActive comparatorBefore 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
Receives: Drug: Compound lidocaine at low concentration
Compound lidocaine at high-concentration in transversus abdominis plane blockActive comparatorBefore 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
Receives: Drug: Compound lidocaine at high concentration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 72 hours after surgery

Secondary outcomes (9)

  1. Time of First Postoperative Analgesic Requirement

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

    Measured: 1 hour after surgery

  2. Total Dose of First Postoperative Analgesic Requirement

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

    Measured: 1 hour after surgery

  3. 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

    Measured: 72 hours after surgery

  4. Occurrence of Side Effects

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

    Measured: 72 hours after surgery

  5. 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.

    Measured: 72 hours after surgery

  6. 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.

    Measured: 30 minutes after transversus abdominis plane block

  7. 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 .

    Measured: 30 minutes after transversus abdominis plane block

  8. Apfel score

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

    Measured: The day before the surgery

  9. Mean time until passage of flatus

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

    Measured: 72 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2021
  2. Study start15 Aug 2021
  3. Primary completion10 Feb 2022
  4. Study completion14 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
164 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04938882
Sponsor's protocol ID
GWang013
Status last verified
Feb 2022
First submitted
22 Jun 2021
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31283738

  • 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.

    PubMed 28271227

  • Zhang L, Jia Z, Gao T, Wang Y, Zhao Y, Li J, Yu Y, Li Q, Wang G. A randomized controlled trial evaluating the effects of transversus abdominis plane block with compound lidocaine hydrochloride injection on postoperative pain and opioid consumption and gastrointestinal motility in patients undergoing gynecological laparotomy. Front Mol Neurosci. 2023 Jan 25;16:967917. doi: 10.3389/fnmol.2023.967917. eCollection 2023.

    PubMed 36760605

Questions about this trial

What is this clinical trial studying?

A study testing Normal saline, Ropivacaine and Compound lidocaine at low concentration in people with Postoperative Pain, run by Tianjin Medical University General Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain Score (NRS) (time frame: 72 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04938882, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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