Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

Pain Clinical Trial

Official title:

Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02932930
• Other study ID #: USJ-02
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2019

Study information

• Verified date: December 2019
• Source: St Joseph University, Beirut, Lebanon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The original concept of a quadratus lumborum block (QLB) indicated for analgesia after abdominal surgery was first described by Blanco in 2007. Also referred to as a posterior transversus abdominis plane (TAP) block, the QLB consists in deposition of local anesthetic on either the posterior or the anterolateral border of the quadratus lumborum muscle. TAP blocks have already been proved effective in urologic, abdominal, and gynecologic procedures by blocking the sensory nerve supply to the anterior abdominal wall thus reducing the amount of postoperative analgesic medication. The main advantages of QLB compared to the TAP block is a wider sensory block area and a longer duration of analgesia. This is due to the extension of local anesthetic agents beyond the TAP plane to the thoracic paravertebral space(4).

Previous reports have shown that QLB is effective in providing pain relief after various abdominal operations. However, there are no published reports on QLB for postoperative pain after abdominoplasty. This prospective, randomized, double-blinded, controlled study aims to evaluate the analgesic efficacy, opioids consumption and quality of recovery of QLB in patients undergoing abdominoplasty. Patients scheduled to have abdominoplasty will be randomized to receive bilateral QLB with either ropivacaine 0.2% or normal saline. Post-operative cumulative analgesic medication consumption, pain severity at rest and on movement, as well as quality of recovery will be evaluated and compared in both groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Standard abdominoplasty procedure

2. Written informed consent

3. Age = 18 years

4. Female

Exclusion Criteria:

1. Patient's refusal

2. Allergies to any study medication

3. Inability to comprehend or participate in scoring scales

4. Deformations that could possibly affect the spread of the local anesthetic in the quadratus lumborum muscle plane

5. Quadratus lumborum muscle plane not seen in ultrasound examination

6. Coagulopathy or on anticoagulants

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Procedure:
• QLB bloc

Drug:
• 0.2% Ropivacaine
0,2ml/kg of 0,2% ropivacaine
• 0.9% normal saline
0,2ml/kg of 0.9% normal saline

Locations

Country	Name	City	State
Lebanon	Hotel Dieu De France	Beirut	Aschrafieh

Sponsors (1)

Lead Sponsor	Collaborator
St Joseph University, Beirut, Lebanon

Country where clinical trial is conducted

Lebanon, 

References & Publications (7)

Baidya DK, Maitra S, Arora MK, Agarwal A. Quadratus lumborum block: an effective method of perioperative analgesia in children undergoing pyeloplasty. J Clin Anesth. 2015 Dec;27(8):694-6. doi: 10.1016/j.jclinane.2015.05.006. Epub 2015 Jul 11. — View Citation

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. — View Citation

Chakraborty A, Goswami J, Patro V. Ultrasound-guided continuous quadratus lumborum block for postoperative analgesia in a pediatric patient. A A Case Rep. 2015 Feb 1;4(3):34-6. doi: 10.1213/XAA.0000000000000090. — View Citation

El-Boghdadly K, Elsharkawy H, Short A, Chin KJ. Quadratus Lumborum Block Nomenclature and Anatomical Considerations. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):548-9. doi: 10.1097/AAP.0000000000000411. — View Citation

Hockett MM, Hembrador S, Lee A. Continuous Quadratus Lumborum Block for Postoperative Pain in Total Hip Arthroplasty: A Case Report. A A Case Rep. 2016 Sep 15;7(6):129-31. doi: 10.1213/XAA.0000000000000363. — View Citation

Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349. — View Citation

Sforza M, Andjelkov K, Zaccheddu R, Nagi H, Colic M. Transversus abdominis plane block anesthesia in abdominoplasties. Plast Reconstr Surg. 2011 Aug;128(2):529-35. doi: 10.1097/PRS.0b013e31821e6f51. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative morphine consumption	Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.	up to 48 hour
Secondary	Time to first tramadol dose	Time to first tramadol dose: time from the discharge to the surgical ward to the first postoperative subcutaneous tramadol dose requested by the patient.	up to 48 hour
Secondary	Postoperative pain severity	Postoperative pain severity in Numerical Rating Scale at rest in the first 48 hour after surgery. Ranging from 0 for no pain to 10 for worst pain imaginable. All patients will be assessed postoperatively by a blinded investigator: at 2, 4, 6, 12, 24, 36, and 48 hour postoperatively.	up to 48 hour
Secondary	Postoperative dynamic pain severity	Postoperative dynamic pain severity (walking, coughing, deep breathing) in Numerical Rating Scale in the first 48 hour after surgery. Ranging from 0 for no pain to 10 for worst pain imaginable. All patients will be assessed postoperatively by a blinded investigator: at 2, 4, 6, 12, 24, 36, and 48 hour postoperatively.	up to 48 hour
Secondary	Nausea or vomiting	Nausea or vomiting up to 48h post operatively (2, 4, 6, 12, 24, 36, and 48 hour postoperatively) using the following four grades scale: 0 = No nausea; 1 = Mild nausea; 2 = Moderate nausea; 3 = Severe nausea or vomiting	up to 48 hour
Secondary	Sedation level	Sedation level up to 48 hour post operatively using the following Ramsay score.	up to 48 hour
Secondary	Quality of recovery	Quality of recovery using the self-assessment quality of recovery (QoR) scale to assess the patient's recovery quality	up to 48 hour
Secondary	Time to first walk	Time to first walk	up to 48 hour