NCT03333902

Brief Summary

The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
24 days until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

7 months

First QC Date

November 2, 2017

Last Update Submit

January 23, 2019

Conditions

Anesthesia, Obstetrical

Keywords

quadratus lumborum blockanesthesiapain, postoperative

Outcome Measures

Primary Outcomes (1)

  • the change trend of Visual Analogue Scale (VAS) at rest and movement

    The purpose is to view the change of the level of pain assessed by subjects at adjacent time points. We would set 0, 4, 6, 12, 24, 48 hours postoperatively as observational time points.

    0-48 hours postoperatively

Secondary Outcomes (2)

  • total morphine consumption

    0-48 hours postoperatively

  • complications

    0-48 hours postoperatively

Study Arms (4)

QLB type 2

EXPERIMENTAL

Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

Procedure: QLBProcedure: Intravenous patient controlled analgesia (PCA)

QLB type 3

EXPERIMENTAL

Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

Procedure: QLBProcedure: Intravenous patient controlled analgesia (PCA)

QLB type 2+3

EXPERIMENTAL

Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

Procedure: QLBProcedure: Intravenous patient controlled analgesia (PCA)

epidural anesthesia group (EA)

ACTIVE COMPARATOR

Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether. Subjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.

Procedure: QLBProcedure: Intravenous patient controlled analgesia (PCA)

Interventions

QLBPROCEDURE

QLB, quadratus lumborum block.

QLB type 2QLB type 2+3QLB type 3epidural anesthesia group (EA)
Intravenous patient controlled analgesia (PCA)PROCEDURE

Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.

QLB type 2QLB type 2+3QLB type 3epidural anesthesia group (EA)

Eligibility Criteria

Age24 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsSubjects undergo cesarean delivery
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I or II
  • weight from 50 to 70 kilogrammes
  • a normal singleton pregnancy
  • ≥37 weeks gestation

You may not qualify if:

  • congenital coagulopathy
  • anatomic abnormalities
  • localized skin infection
  • allergy to any of the drugs used

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (1)

  • Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.

    PMID: 26225500BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 7, 2017

Study Start

December 1, 2017

Primary Completion

June 30, 2018

Study Completion

August 30, 2018

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)