Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty

• Sponsor: St Joseph University, Beirut, Lebanon (Other)
• Overall Status: Completed
• CT.gov ID: NCT02932930
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 34
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pain	Procedure: QLB bloc; Drug: 0.2% Ropivacaine; Drug: 0.9% normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Ultrasound Guided Quadratus Lumborum Block for Postoperative Pain in Abdominoplasty: A Randomized Controlled Study
• Actual Study Start Date: Oct 1, 2016
• Actual Primary Completion Date: Jun 1, 2019
• Actual Study Completion Date: Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: QLB group Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.2% ropivacaine bilaterally. Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Ropivacaine, 0.2 ml/kg of 0.2% ropivacaine	Procedure: QLB bloc; Drug: 0.2% Ropivacaine; 0,2ml/kg of 0,2% ropivacaine
Placebo Comparator: Control group Patients will receive at the beginning of the surgery 0.2 ml/kg of 0.9% normal saline bilaterally. Procedure: Quadratus Lumborum Block type II, local anesthetic injection on the posterior border of the quadratus lumborum muscle Drug: Normal saline, 0.2 ml/kg of 0.9 % normal saline	Procedure: QLB bloc; Drug: 0.9% normal saline; 0,2ml/kg of 0.9% normal saline

Outcome Measures

Primary Outcome Measures

1. Cumulative morphine consumption [up to 48 hour]

   Cumulative morphine consumption in mg while in the PACU and tramadol dose till 48 hour post operatively.

Secondary Outcome Measures

1. Time to first tramadol dose [up to 48 hour]

   Time to first tramadol dose: time from the discharge to the surgical ward to the first postoperative subcutaneous tramadol dose requested by the patient.

2. Postoperative pain severity [up to 48 hour]

   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.

3. Postoperative dynamic pain severity [up to 48 hour]

   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.

4. Nausea or vomiting [up to 48 hour]

   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

5. Sedation level [up to 48 hour]

   Sedation level up to 48 hour post operatively using the following Ramsay score.

6. Quality of recovery [up to 48 hour]

   Quality of recovery using the self-assessment quality of recovery (QoR) scale to assess the patient's recovery quality

7. Time to first walk [up to 48 hour]

   Time to first walk

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hotel Dieu De France	Beirut	Aschrafieh	Lebanon	00961

Sponsors and Collaborators

• St Joseph University, Beirut, Lebanon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Sforza M, Andjelkov K, Zaccheddu R, Nagi H, Colic M. Transversus abdominis plane block anesthesia in abdominoplasties. Plast Reconstr Surg. 2011 Aug;128(2):529-535. doi: 10.1097/PRS.0b013e31821e6f51.

• Responsible Party: samer jabbour, MD, St Joseph University, Beirut, Lebanon
• ClinicalTrials.gov Identifier: NCT02932930
• Other Study ID Numbers: USJ-02
• First Posted: Oct 13, 2016
• Last Update Posted: Dec 13, 2019
• Last Verified: Dec 1, 2019

• Keywords provided by samer jabbour, MD, St Joseph University, Beirut, Lebanon: QLB; Abdominoplasty; Quadratus lumborum block
• Additional relevant MeSH terms: Pain, Postoperative; Ropivacaine

Study Results

No Results Posted as of Dec 13, 2019