The Comparison Of Nerve Blocks In Cesarean Delivery

Sponsor

Feng Xia (Other)

Overall Status

Completed

CT.gov ID

NCT03333902

Collaborator

(none)

102

Enrollment

Location

Arms

8.9

Actual Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, Obstetrical	Procedure: QLB Procedure: Intravenous patient controlled analgesia (PCA)	N/A

Detailed Description

Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.

Study Design

Study Type:

Interventional

Actual Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial

Actual Study Start Date :

Dec 1, 2017

Actual Primary Completion Date :

Jun 30, 2018

Actual Study Completion Date :

Aug 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: QLB type 2 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: QLB QLB, quadratus lumborum block. Procedure: Intravenous patient controlled analgesia (PCA) Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
Experimental: QLB type 3 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: QLB QLB, quadratus lumborum block. Procedure: Intravenous patient controlled analgesia (PCA) Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
Experimental: QLB type 2+3 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: QLB QLB, quadratus lumborum block. Procedure: Intravenous patient controlled analgesia (PCA) Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
Active Comparator: epidural anesthesia group (EA) 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: QLB QLB, quadratus lumborum block. Procedure: Intravenous patient controlled analgesia (PCA) Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.

Outcome Measures

Primary Outcome Measures

the change trend of Visual Analogue Scale (VAS) at rest and movement [0-48 hours postoperatively]
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.

Secondary Outcome Measures

total morphine consumption [0-48 hours postoperatively]
total morphine consumption
complications [0-48 hours postoperatively]
nausea, vomiting, retention of urine, lower limb weakness, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:

24 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital of Sun Yat-Sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

Feng Xia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen University

ClinicalTrials.gov Identifier:

NCT03333902

Other Study ID Numbers:

[2016]123

First Posted:

Nov 7, 2017

Last Update Posted:

Jan 24, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Feng Xia, Professor, First Affiliated Hospital, Sun Yat-Sen University

quadratus lumborum block

anesthesia

pain, postoperative

Study Results

No Results Posted as of Jan 24, 2019