NCT02036749

Brief Summary

The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics close to the anterior border of the quadratus lumborum muscle. In our randomized, controlled, double-blinded study ultrasound-guided QL-blocks in 20 female patients after cesarean delivery will be compared with a placebo control group of 20 patients to investigate analgesic consumption, pain level, opioid related side effects and mobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable postoperative-pain

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

Study Start

First participant enrolled

January 1, 2014

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

October 7, 2015

Status Verified

October 1, 2015

Enrollment Period

1.2 years

First QC Date

January 13, 2014

Last Update Submit

October 6, 2015

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • morphine consumption

    48 hours

Secondary Outcomes (1)

  • pain level (NRS)

    48 hours

Other Outcomes (1)

  • time to mobilization

    48 hours

Study Arms (2)

quadratus lumborum block (nerve block)

ACTIVE COMPARATOR

quadratus lumborum block with ropivacaine

Procedure: nerve block

sham block

PLACEBO COMPARATOR

QL block with saline

Procedure: nerve block

Interventions

nerve blockPROCEDURE

quadratus lumborum block

Also known as: quadratus lumborum block
quadratus lumborum block (nerve block)sham block

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with cesarean delivery
  • American Society of Anesthesiologists classification (ASA) \< 3
  • adequate communication skills
  • Body mass index \< 32

You may not qualify if:

  • ASA \> 2
  • chronic pain
  • neurological illness/ neuropathy
  • contraindication against local anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0023, Norway

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Nerve Block

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Anders Krohg, MD

    Oslo University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 13, 2014

First Posted

January 15, 2014

Study Start

January 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

October 7, 2015

Record last verified: 2015-10

Locations

NO(1)