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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cesarean Section; Quadratus Lumborum Block; Iliohypogastric/Ilioinguinal Nerve Block
• Intervention / Treatment: Procedure: quadratus lumborum block; Procedure: iliohypogastric/ilioinguinal nerve block; Procedure: epidural analgesia

• Study Type: Interventional
• Enrollment (Anticipated): 87
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: quadratus lumborum block; Parturients receive ultrasound-guided quadratus lumborum block as post-operative analgesia.	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.
Experimental: iliohypogastric/ilioinguinal nerve block; Parturients receive ultrasound-guided iliohypogastric/ilioinguinal nerve block as post-operative analgesia.	Procedure: 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.
Active Comparator: epidural analgesia; Parturients receive epidural morphine via epidural catheter placed during anesthesia as post-operative analgesia.	Procedure: epidural analgesia; Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
hospital stay	The hospitalize length	at discharge assessed up to 10 days
hospitalize cost	Total cost in this hospitalization	at discharge assessed up to 10 days

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2021
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 2, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 2021-Z-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No