The Comparison Of Nerve Blocks In Cesarean Delivery

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Obstetrical
• Intervention / Treatment: Procedure: QLB; Procedure: Intravenous patient controlled analgesia (PCA)

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital of Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
total morphine consumption	total morphine consumption	0-48 hours postoperatively
complications	nausea, vomiting, retention of urine, lower limb weakness, etc.	0-48 hours postoperatively

Collaborators and Investigators

• Sponsor: Feng Xia

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): August 30, 2018

Study Registration Dates

• First Submitted: November 2, 2017
• First Submitted That Met QC Criteria: November 5, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 23, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: anesthesia; quadratus lumborum block; pain, postoperative
• Other Study ID Numbers: [2016]123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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