Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?

Postoperative Pain Clinical Trial

Official title:

Postoperative Pain Relief After Cesarean Section: Is There a Role for the Quadratus Lumborum Block?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328378
• Other study ID #: Ch27021403
• Status: Completed
• Phase: N/A
• First received: December 25, 2014
• Last updated: May 22, 2016
• Start date: September 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2016
• Source: Corniche Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Arab Emirates: General Authority for Health Services for Abu Dhabi
• Study type: Interventional

Clinical Trial Summary

The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents produces extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that TAP block may not be effective in improving postoperative analgesia in patients who had cesarean section under spinal anaesthesia.

The aim of this randomised controlled, double blinded study is to examine the effect of QLB on the postoperative pain management in patients who had cesarean section under spinal anesthesia.

Description:

After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 25 patients per group was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.

Consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to undergo QLB with Bupivacaine versus placebo(saline) after their surgery. Allocation will be done using closed envelope technique.

The study medications/placebo will be prepared and labelled by an anesthetist who is not involved in the study.

All patients will receive a standard spinal anesthetic. At the end of surgery , Quadratus lumborum block group (QL) patients will receive bilateral QLB with 0.125% bupivacaine.

Control group patients will receive a bilateral placebo block using saline. The block will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.

The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers.

A 22 Gauge, two inch Pajunk Sonoplex needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. Following negative aspiration, 0.2 ml/kg of 0.125% bupivacaine, or placebo(saline) is injected in each side with intermittent aspiration and the spread of injectate followed on ultrasound.

All patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.

All patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Elective caesarean sections

• ASA 1 to 3

• Written informed consent.

Exclusion Criteria:

• Patient refusal

• Local infection at the site of injection

• Allergy to study medications

• Sepsis

• Anatomic abnormalities

• Systemic anticoagulation or coagulopathy

• Inability to comprehend or participate in pain scoring system

• Inability to use intravenous patient controlled analgesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Quadratus Lumborum block
Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.

Locations

Country	Name	City	State
United Arab Emirates	Corniche Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Tarek Ansari

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine used in the first 48 hours after surgery	Total cumulative morphine dose in mg used in the first 48 hours after surgery	48 hours	No
Secondary	Nausea or vomiting	Categorical assessment of nausea. 0 = No Nausea; = Mild Nausea.; = Moderate; = Severe Nausea or Vomit	48 hours	No
Secondary	Sedation score in the first 48 hours	Categorical assessment of sedation. 0 = wide awake; = drowsy but responds to normal verbal communication.; = asleep, but awakes with verbal communication.; = asleep, awakens with mild physical stimulation.; = asleep, unresponsive to mild physical stimulation.	48 hours	No
Secondary	Severity of postoperative pain via visual analogue pain scale	VAS range from 0 for no pain to 10 for worst pain imaginable	48 hours	No