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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04822870
Other study ID # 2021-Z-01
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date March 31, 2021
Est. completion date May 2021

Study information

Verified date April 2021
Source Peking University People's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 87
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
quadratus lumborum block
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.
iliohypogastric/ilioinguinal nerve block
Iliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section.
epidural analgesia
Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 hours postoperatively
Secondary 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. 6 hours postoperatively
Secondary 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. 12 hours postoperatively
Secondary 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. 48 hours postoperatively
Secondary 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. 6 hours postoperatively
Secondary 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. 12 hours postoperatively
Secondary 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. 24 hours postoperatively
Secondary 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. 48 hours postoperatively
Secondary effective analgesia time Time period between finish the intervention and the first time parturient use the patient-controlled intravenous analgesia pump for analgesia supplement. 48 hours postoperatively
Secondary 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. 6 hours postoperatively
Secondary 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. 12 hours postoperatively
Secondary 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. 24 hours postoperatively
Secondary 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. 48 hours postoperatively
Secondary satisfaction score Ask the patient to evaluate satisfaction score using 0-10. 0 refers totally dissatisfied, 10 refers to the most satisfied 48 hours postoperatively
Secondary hospital stay The hospitalize length at discharge assessed up to 10 days
Secondary hospitalize cost Total cost in this hospitalization at discharge assessed up to 10 days
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