NCT04822870

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

March 31, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

1 month

First QC Date

March 17, 2021

Last Update Submit

April 2, 2021

Conditions

Quadratus Lumborum BlockIliohypogastric/Ilioinguinal Nerve BlockCesarean Section

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • morphine consumption

    6 hours postoperatively

  • morphine consumption

    12 hours postoperatively

  • morphine consumption

    48 hours postoperatively

  • pain score

    6 hours postoperatively

  • pain score

    12 hours postoperatively

  • +10 more secondary outcomes

Study Arms (3)

quadratus lumborum block

EXPERIMENTAL

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

Procedure: quadratus lumborum block

iliohypogastric/ilioinguinal nerve block

EXPERIMENTAL

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

Procedure: iliohypogastric/ilioinguinal nerve block

epidural analgesia

ACTIVE COMPARATOR

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

Procedure: epidural analgesia

Interventions

quadratus lumborum blockPROCEDURE

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.

quadratus lumborum block
iliohypogastric/ilioinguinal nerve blockPROCEDURE

Iliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section.

iliohypogastric/ilioinguinal nerve block
epidural analgesiaPROCEDURE

Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.

epidural analgesia

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Officials

  • Yi Feng, MD

    Peking University People's Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 30, 2021

Study Start

March 31, 2021

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

CN(1)