Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section

Postoperative Pain Clinical Trial

Official title:

Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489851
• Other study ID #: Ch23031404
• Status: Completed
• Phase: N/A
• First received: July 2, 2015
• Last updated: May 22, 2016
• Start date: June 2015
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• 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 may produce extensive analgesia and prolonged action of the injected local anesthetic solution.

Previous studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.

The aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block 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 72 patients (36 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 receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.

All the blocks 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.

All patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed 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: 76
• Est. completion date: December 2015
• Est. primary completion date: December 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
0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
• Tranversus Abdominis plane block
0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.

Locations

Country	Name	City	State
United Arab Emirates	Corniche Hospital	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Corniche Hospital

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	Severity of postoperative pain via visual analogue pain scale (VAS)	VAS range from 0 for no pain to 10 for worst pain imaginable	48 hours	No
Secondary	Nausea or vomiting	0 = No Nausea; = Mild Nausea.; = Moderate; = Severe Nausea or Vomiting	48 hours	No
Secondary	Sedation score	= 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