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

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Normal saline
Ropivacaine
Compound lidocaine at low concentration
Compound lidocaine at high concentration
Sponsored by
Tianjin Medical University General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring Compound lidocaine, Ropivacaine, pain intensity, Transversus abdominis plane block

Eligibility Criteria

20 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Tianjin Medical University General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Normal saline in transversus abdominis plane block

Ropivacaine in transversus abdominis plane block

Compound lidocaine at low-concentration in transversus abdominis plane block

Compound lidocaine at high-concentration in transversus abdominis plane block

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Total Dose of First Postoperative Analgesic Requirement
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
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
Occurrence of Side Effects
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
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.
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.
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 .
Apfel score
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Mean time until passage of flatus
Gastrointestinal motility was evaluated by recording mean time until passage of flatus

Full Information

First Posted
June 22, 2021
Last Updated
February 21, 2022
Sponsor
Tianjin Medical University General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04938882
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tianjin Medical University General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Compound lidocaine, Ropivacaine, pain intensity, Transversus abdominis plane block

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
164 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal saline in transversus abdominis plane block
Arm Type
Placebo Comparator
Arm Description
Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
Arm Title
Ropivacaine in transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Compound lidocaine at low-concentration in transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
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
Arm Title
Compound lidocaine at high-concentration in transversus abdominis plane block
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
0. 9% Sodium Chloride Injection
Intervention Description
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 Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Ropivacaine Hydrochloride Injection
Intervention Description
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 Type
Drug
Intervention Name(s)
Compound lidocaine at low concentration
Other Intervention Name(s)
Compound Hydrochloride Lidocaine Injection
Intervention Description
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 Type
Drug
Intervention Name(s)
Compound lidocaine at high concentration
Other Intervention Name(s)
Compound Hydrochloride Lidocaine Injection
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain Score (NRS)
Description
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 Outcome Measure Information:
Title
Time of First Postoperative Analgesic Requirement
Description
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Time Frame
1 hour after surgery
Title
Total Dose of First Postoperative Analgesic Requirement
Description
First postoperative pain (NRS≥5) is initially controlled by titration of sufentanyl.
Time Frame
1 hour after surgery
Title
Cumulative Sufentanyl Consumption
Description
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
Title
Occurrence of Side Effects
Description
Occurrence of side effects: nausea, vomiting, dizziness, headache, shivering, pruritus
Time Frame
72 hours after surgery
Title
Normalized Area of Hyperalgesia Around the Incision
Description
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.
Time Frame
72 hours after surgery
Title
The onset time of sensory block
Description
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.
Time Frame
30 minutes after transversus abdominis plane block
Title
Diffusion area of local anesthetics after transversus abdominis plane block
Description
Diffusion area of local anesthetics after transversus abdominis plane block was calculated under ultrasound assistance .
Time Frame
30 minutes after transversus abdominis plane block
Title
Apfel score
Description
The Apfel score was recorded for evaluating risk for developing postoperative nausea and vomiting (PONV).
Time Frame
The day before the surgery
Title
Mean time until passage of flatus
Description
Gastrointestinal motility was evaluated by recording mean time until passage of flatus
Time Frame
72 hours after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guolin Wang, MD
Organizational Affiliation
Tianjin Medical University General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
ZIP/Postal Code
300052
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31283738
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.
Results Reference
background
PubMed Identifier
28271227
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.
Results Reference
background

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

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