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Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section

Primary Purpose

Quadratus Lumborum Block, Iliohypogastric/Ilioinguinal Nerve Block, Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
quadratus lumborum block
iliohypogastric/ilioinguinal nerve block
epidural analgesia
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quadratus Lumborum Block

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • singleton pregnancy
  • gestation of at least 37 weeks
  • American Society of Anesthesiologists (ASA) physical status I or II
  • finish Pfannenstiel section under combined spinal and epidural anesthesia

Exclusion Criteria:

  • pruritus existed before the surgery
  • allergic to lidocaine, ropivacaine or dexamethasone

Sites / Locations

  • Peking University People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

quadratus lumborum block

iliohypogastric/ilioinguinal nerve block

epidural analgesia

Arm Description

Parturients receive ultrasound-guided quadratus lumborum block as post-operative analgesia.

Parturients receive ultrasound-guided iliohypogastric/ilioinguinal nerve block as post-operative analgesia.

Parturients receive epidural morphine via epidural catheter placed during anesthesia as post-operative analgesia.

Outcomes

Primary Outcome Measures

morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.

Secondary Outcome Measures

morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
morphine consumption
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
pain score
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
effective analgesia time
Time period between finish the intervention and the first time parturient use the patient-controlled intravenous analgesia pump for analgesia supplement.
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
adverse effect
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
satisfaction score
Ask the patient to evaluate satisfaction score using 0-10. 0 refers totally dissatisfied, 10 refers to the most satisfied
hospital stay
The hospitalize length
hospitalize cost
Total cost in this hospitalization

Full Information

First Posted
March 17, 2021
Last Updated
April 2, 2021
Sponsor
Peking University People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04822870
Brief Title
Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section
Official Title
Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section: a Randomized Double-blind Clinical Trial Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 31, 2021 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital

4. Oversight

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

5. Study Description

Brief Summary
The purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadratus Lumborum Block, Iliohypogastric/Ilioinguinal Nerve Block, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
87 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
quadratus lumborum block
Arm Type
Experimental
Arm Description
Parturients receive ultrasound-guided quadratus lumborum block as post-operative analgesia.
Arm Title
iliohypogastric/ilioinguinal nerve block
Arm Type
Experimental
Arm Description
Parturients receive ultrasound-guided iliohypogastric/ilioinguinal nerve block as post-operative analgesia.
Arm Title
epidural analgesia
Arm Type
Active Comparator
Arm Description
Parturients receive epidural morphine via epidural catheter placed during anesthesia as post-operative analgesia.
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block
Intervention Description
Quadratus lumborum block is an effective nerve block method in post-cesarean section analgesia. It is a relatively new technique that may provide analgesic effect in somatic pain and visceral pain, but has not been verified yet.
Intervention Type
Procedure
Intervention Name(s)
iliohypogastric/ilioinguinal nerve block
Intervention Description
Iliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section.
Intervention Type
Procedure
Intervention Name(s)
epidural analgesia
Intervention Description
Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.
Primary Outcome Measure Information:
Title
morphine consumption
Description
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
morphine consumption
Description
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Time Frame
6 hours postoperatively
Title
morphine consumption
Description
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Time Frame
12 hours postoperatively
Title
morphine consumption
Description
Every parturient use a patient-controlled intravenous analgesia pump as supplement for the interventions. The analgesia pump contains morphine and can record morphine consumption. Postoperative use of morphine can reflect analgesic effect.
Time Frame
48 hours postoperatively
Title
pain score
Description
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Time Frame
6 hours postoperatively
Title
pain score
Description
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Time Frame
12 hours postoperatively
Title
pain score
Description
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Time Frame
24 hours postoperatively
Title
pain score
Description
Use visual analogue scale (VAS) 0-10 to evaluate pain intensity and reflect analgesic effect. 0 refers to completely no pain, 10 refers to the most severe pain she has experienced.
Time Frame
48 hours postoperatively
Title
effective analgesia time
Description
Time period between finish the intervention and the first time parturient use the patient-controlled intravenous analgesia pump for analgesia supplement.
Time Frame
48 hours postoperatively
Title
adverse effect
Description
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Time Frame
6 hours postoperatively
Title
adverse effect
Description
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Time Frame
12 hours postoperatively
Title
adverse effect
Description
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Time Frame
24 hours postoperatively
Title
adverse effect
Description
Nausea and vomiting, pruritus, oversedation, respiratory depression and urinary retention are considered adverse effects. The incidence and severity are recorded, 1 score refers to mild, 2 scores refers to moderate, 3 scores refers to severe and treatment needed.
Time Frame
48 hours postoperatively
Title
satisfaction score
Description
Ask the patient to evaluate satisfaction score using 0-10. 0 refers totally dissatisfied, 10 refers to the most satisfied
Time Frame
48 hours postoperatively
Title
hospital stay
Description
The hospitalize length
Time Frame
at discharge assessed up to 10 days
Title
hospitalize cost
Description
Total cost in this hospitalization
Time Frame
at discharge assessed up to 10 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: singleton pregnancy gestation of at least 37 weeks American Society of Anesthesiologists (ASA) physical status I or II finish Pfannenstiel section under combined spinal and epidural anesthesia Exclusion Criteria: pruritus existed before the surgery allergic to lidocaine, ropivacaine or dexamethasone
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Feng, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China

12. IPD Sharing Statement

Learn more about this trial

Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section

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