Comparison of quadratus lumborum block for postoperative analgesia after abdominal surgery

Not yet recruiting

• Conditions: Disease of digestive system, unspecified,

• Registration Number: CTRI/2023/08/057027
• Lead Sponsor: Department of Anaesthesiology

Brief Summary

**COMPARISON OF LEVOBUPIVACAINE ANDROPIVACAINE IN QUADRATUS LUMBORUM BLOCK FOR POSTOPERATIVE ANALGESIA AFTERABDOMINAL SURGERY**

**INTRODUCTION**

Patients, who will have major abdominal surgery, need seriouspain management at the postoperative period. Many trials revealed that,conventional pain management with intramuscular analgesics is insufficient formany patients. Postoperative painremains a concern following surgery and is a source of morbidity, increasedhospital stay, and dissatisfaction.

In the search for the wider analgesia coverage andlong-lasting postoperative analgesia have been developed. Quadratus lumborum (QL) block, first reported in 2007by Blanco, is a posterior abdominal wall block which permits spread of localanaesthetic agent behind the quadratus lumborum muscle into a triangular spaceknown as a lumbar interfascial triangle which lies beside the middle layer ofthe thoracolumbar fascia.1 Thisinterfascial plane is in adjoining proximity with numerous sympathetic fibresand conjoin with the thoracic paravertebral space, thus preceding to along-standing block with the capability to provide visceral analgesia.2,3 Various studies are there showingeffective post-operative analgesic profile of QL block.4-6

Since the initial description, the block has experienced severalmodifications and today four types of the block are performed, which differ bythe site of drug application. These are QLB 1 or lateral QLB, QLB 2 orposterior QLB, QLB 3, or anterior/transmuscular QLB, and QLB 4 or intramuscularQLB. Quadratus lumborum block 2 implies the application of medication on theposterior side of the QLM between the QLM and the medial lamina of TLF whichseparates QLM from the latissimus dorsi muscle and paraspinal muscles [erectorspinae muscles (ESM)]. This is laterally from the attachment of IOMaponeurosis, in the to the so-called lumbar interfascial triangle.

Although the evidence base is weak and still growing, the data thus farsuggest that quadratus lumborum block potentially results in extensive sensoryblockade (T7–L2). Quadratus lumborum block may lead to dermatomal coveragerequired for abdominal surgery and hip surgery, representing an avenue forfuture research.4,7

Ropivacaine and levobupivacaine, the newer long-acting LAagents and S (−) isomers with a favourable safety profile, were introduced intoclinical practice. It has been recently demonstrated that levobupivacainecontributes a different clinical profile because of its high lipophilic andvasoconstrictor properties compared to ropivacaine. Ropivacaine is about 40%less potent than racemic bupivacaine, while levobupivacaine has the samepotency of racemic bupivacaine.8

Levobupivacaine is the S(-) enantiomer of bupivacaine, a longacting amino-ester local anaesthetic agent. Levobupivacaine is the LA agentwith a higher threshold for systemic toxicity and with lesser cardiac andcentral nervous system side effects. Single-shot regional anaesthesia usinglevobupivacaine has a long duration of analgesia compared to ropivacaine**.**7

Ropivacaine, is the local anesthetic with a better toxicityprofile compared with alternatives, such as bupivacaine, is currentlyconsidered the safest, long-acting local anesthetic available in the market.Two trials comparing the plasma concentration after intravenous use ofropivacaine versus bupivacaine have demonstrated that ropivacaine requires ahigher plasma concentration before toxicity develops.  Previous studiesof peripheral nerve blocks (PNBs) with levobupivacaine have suggested that theduration of analgesia of levobupivacaine might be longer than that of anequivalent dose of bupivacaine or ropivacaine.9  So, we hypothesizedthat levobupivacaine will increase the time to rescue analgesia in comparisonto ropivcaine in quadratus lumborum block too. In this study, we will comparelevobupivacaine and ropivacaine in quadratus lumborum block for postoperativeanalgesia after abdominal surgery.

**AIMS AND OBJECTIVES**

**AIM:**

•     To compare Levobupivacaine and Ropivacaine in quadratus lumborum blockfor postoperative analgesia after abdominal surgery

**OBJECTIVES**

**PrimaryObjective:**

•     To study duration of analgesia i.e. time needed for  first rescue analgesia in postoperative period.

**SecondaryObjectives:**

•     Total  rescue analgesic consumption in postoperativeperiod

•     Postoperative pain scores using the visual analog scale (VAS) for painat rest in the postoperative period at 0, 1, 6, 12, and 24 hours.

•     Postoperative patient’s hemodynamics by mean blood pressure and heartrate at 0, 1, 6, 12, and 24 hours.

•     Incidence of nausea and vomiting

•     To compare complications if any

  **MATERIAL AND METHODS**

**Study setting:**

The studywill be conducted in Department of Anesthesiology, King George’s MedicalUniversity, Lucknow after written informed consent will be obtained from eitherof the patients/Guardian.

**Study duration :** One year

**Study design:**

Randomized parallelstudy

**Sample size:**

76

**InclusionCriteria:**

·        Patients giving written consent will be taken

·        Patientsof either sex aged 18-65 years

·        ASAI-II patients scheduled to undergone

**ExclusionCriteria:**

·        Localinfection at site of block

·        Cardiovasculardisease

·        H/oallergy to study medications

·        knownhypersensitivity to LA

·        bodymass index ≥35 kg/m2,≤16kg/m2

·        historyof opioid addiction

·        bleedingdiathesis

·        renaland hepatic dysfunctions

·        pregnancy

**Methodology:**

The study will be conducted after getting approval from ethics committeeof King Georges Medical University, Lucknow after taking patient’s consent. Acomputer system will be used for randomization by creating a list of numbereach number referred to one of the two groups. Block randomization will be usedto ensure equality of the groups. The patient’s will be divided into 2 groupsusing opaque sealed envelope technique.

Group A : All patient received 0.25% Levobupivacaine with quadratuslumborum block

Group B:  All patients received 0..375% Ropivacaine  with quadratus lumborum block

 A detailed preoperative check-up will carried out one day beforesurgery. The patients will explained in detail about the anaesthesia procedure.The patients will kept fasting as per institutional protocol (2 h for clearliquid and 6 h for semisolid and solid) before surgery. The patients willpre-medicated with tablets alprazolam 0.5 mg and pantoprazole 40 mg previousnight of surgery.

In the operation theatre, an intravenous (IV) cannula of 18G will be secured in non-dominant hand and ringer lactate at a rate of 10 ml/kgstarted. The standard ASA monitors in the form of electrocardiogram (ECG),pulse oximetry (SpO2), non-invasive blood pressure (NIBP) will be applied andbaseline vital parameters will be recorded. All patients  will be given general anesthesia.

After attaching ASA standard monitors patients will bepreoxygenated with 100% oxygen and premedicated with glycopyrolate  0.2mg/kg and fentanyl 2mcg/kg and anesthesiawill be induced with propofol 2mg/kg inj., Vecronium 0.1mg/kg as musclerelaxant then airway will be secured with endotracheal tube according to the weight of the patient andmaintenance of anesthesia will be done with oxygen  and nitrous oxide(1:1), vecronium, fentanyland sevoflurane. After the completion of surgery quadratus lumborum block willbe performed bilaterally in both groups. For patients randomized to the studygroup, a curvilinear ultrasound probe will be placed in the posteriorâ€axillaryline, right above the iliac crest to identify the transversus abdominis,quadratus lumborum, and psoas muscles. Using sterile technique, a 22 gauge  needle will be insertedand advanced under ultrasound guidance below the fascia covering of the QLmuscle, with the tip of the needle ending between the psoas and QL muscles. Theoptimal point of injection will be determined using hydrodissection with 2 mlof 0.9% normal saline (NS). After correct tip placement, the drug will beinjected in 5 ml increments with intermittent aspiration. During the injection,the distribution of LA will be observed as a hypoechoic enlargement onultrasonography The group A will be given 20 ml of 0.25% inj. levobupivacaine onboth sides of abdomen and group B  willbe given 20 ml of 0.375% inj. ropivacaine with a total volume of 20 ml bothsides of abdomen.

Duration of analgesia i.e. time to first rescue analgesiaafter surgery will be recorded. The HR, NIBP, SpO2 and respiratory rate (RR) willbe recorded in the first 24 hrs. and other parameters like total analgesic consumption in postoperative period, postoperativepain scores using the visual analog scale (VAS) for pain at rest in thepostoperative period at 0, 1, 6, 12 and 24 will be observed. If any patient will have VAS > 3, Inj Tramadol2mg/kg will be given as first rescue analgesic and if after giving Tramadol,VAS will not decrease less than four within 30 minutes Inj Diclofenac will beused as second rescue analgesic. Adverse effects including nausea, vomiting,hypotension, bradycardia, arrhythmia any complications (LA toxicity)  till 24 h after surgery will be compared inboth groups. The patientsatisfaction will be graded as poor (1), fair (2), good (3), excellent (4).

Sample Size

**Thesample size formulae used are as follows: 10**

 xSectional Two Proportion

 

| | |

| --- | --- |

|**Two-sided significance level(1-alpha):**

**90**

|**Power(1-beta, % chance of detecting):**

80

|**Ratio of sample size, Unexposed/Exposed:**

1

|**Percent of Unexposed with Outcome:**

20

|**Percent of Exposed with Outcome:**

2.2

|**Odds Ratio:**

0.09

|**Risk/Prevalence Ratio:**

\*\*0.11 (Gözen Öksüz et al., 2020)11

|**Risk/Prevalence difference:**

-18

|

|**TOTAL SAMPLE SIZE**

**76 (38 in each group)**

\*\*Risk of rate ofpost operative rescue analgesia in QL block group vs. Control group.

 **Statistical analysis:**

Data will be entered in Microsoft excel and analyzed using statisticalsoftware SPSS version25(Chicago, IL, USA). Student’s *t* testwill be used to analyze parametric data, while the Mann-Whitney *U* testwas applied to non-parametric data and Fisher’s test to categorical data. Pvalues < 0.05 will be considered statistically significant.

**Ethical approval**:

It will be taken from the Institutional Ethics Committee of theuniversity.

**REVIEW OF LITERATURE**

**Kumar GD  et al (2018)12** conducted a prospective, randomized,double-blinded study total 70 adult patients were randomly allocated into twogroups, where Group A received TAP block with 20 ml of 0.25% ropivacaine oneach side (n = 35) and Group B received QL block with 20 ml of 0.25%ropivacaine on each side (n = 35). The time of block, duration of surgery,Numerical Pain Intensity Scale (NPIS) score at the 1st, 2nd, 4th, 8th, 12th,16th, and 24th postoperative hours, and the total analgesic drug requirementswere noted and compared between the two groups. The time for first analgesicrequirement was 243.00 ± 97.36 min and 447.00 ± 62.52 min and the totalanalgesic consumption (morphine in mg) was 5.65 ± 1.55 and 3.25 ± 0.78 in GroupA and Group B, respectively, both of which were statistically significant(P<0.01). There was a significant difference in postoperative pain scores(NPIS scale 0–10) at rest, between the two groups, up to 16 h. Patients whoreceived QL block had a significant improvement in postoperative pain reliefwith reduced consumption of opioids.

**Deng W****et al(2019)13** conducted a study that total 74 patientsscheduled for laparoscopic colorectal surgery were randomly assigned into 2groups. After surgery, patients received bilateral ultrasound-guidedsingle-dose of QLB or TAPB. Each side was administered with 20 ml of 0.375%ropivacaine. All patients received sufentanil as patient-controlled intravenousanalgesia (PCIA). Resting and moving numeric rating scale (NRS) were assessedat 2, 4, 6, 24, 48 hours postoperatively. The primary outcome measure wassufentanil consumption at predetermined time intervals after surgery. Patientsin the QLB group used significantly less sufentanil than TAPB group at 24 and48 hours (*P* < .05), but not at 6 hours (*P* = .33) afterlaparoscopic colorectal surgery. No significant differences in NRS results werefound between the two groups at rest or during movement (*P* > .05).Incidence of dizziness in the QLB group was lower than in TAPB group (*P* < .05).The QLB is a more effective postoperative analgesia as it reduces sufentanilconsumption compared to TAPB in patients undergoing laparoscopic colorectalsurgery.

**Wang Y et al (2021)14** evaluated the effect of ultrasound-guided quadratus lumborumblock (QLB) preemptive analgesia on recovery in colon cancer patientsundergoing open radical surgery in 56 patients. Patients weredivided into two groups: Group Q (n=27), which received QLB combined generalanesthesia, and Group C (n=29), which received general anesthesia only. Bothgroups were given self-controlled intravenous analgesia pump after surgery. Theprimary outcome is a series of parameters representing postoperative recovery.The secondary outcome was VAS scores and opioid consumption. The rest and active VAS scores were significantlylower in Group Q (*P*<0.01). The opioids consumption was significantlydecreased in Group Q (*P*<0.05).

 **Murouchi, T, et al(2016)15** conducted a study thattotal II patients scheduled for laparoscopic ovarian surgery under generalanesthesia. The patients received bilateral single-injection QLBS (20 mL of0.375% ropivacaine per side). Arterial blood was sampled at 10, 20, 30, 45, 60,90, and 120 minutes after ropivacaine administration. The results wereretrospectively compared with the results of our previous study on lateralTAPB. The median duration of analgesia after QLB exceeded 24 hours and wassignificantly longer than the duration of lateral TAPB (P = 0.003). Quadratuslumborum block affected the T7-T12 dermatomes, whereas TAPB affected T10-T12.Arterial ropivacaine levels after block peaked at comparable time in the QLBand lateral TAPB groups (Tmax: 35 [SD, 13] vs 35 [SD, 11] minutes; P = 0.93).Peak ropivacaine concentrations were significantly lower in QLB than in lateralTAPB (Cmax: 1.0 [SD, 0.5] vs 1.8 [SD. 0.4] µg/mL; P = 0.0003). Quadratuslumborum block resulted in a widespread and long-lasting analgesic effect afterlaparoscopic ovarian surgery and resulted in lower peak arterial ropivacaineconcentrations as compared with those of lateral TAPB after 150 mg ropivacaineinjection.

**MalavK,  etal** **(2018)16** conducted aprospective double-blind, randomised study was carried out in 100 patients ofeither sex, aged between 20 to 60 years, and American Society ofAnesthesiologist (ASA) grades I and II. Patients were randomly allocated intogroups R and L of 50 each with 0.5% ropivacaine and 0.5% levobupivacaine,respectively, for sciatic nerve block using the Labat approach. They assessedthe onset and duration of sensory and motor block, duration of analgesia,consumption of analgesic, and any untoward effect over 24 hours. Both thegroups were comparable with regard to demographic variables and onset ofsensory and motor block (p>0.05). Group L compared to group R hadsignificantly longer median (95% confidence interval) duration of sensory block(647.50 min [624.99–674.41] vs. 535 min [524.77–559.83], respectively;p<0.0001) as well as motor block (1065.0 min [1054.5–1068.90] and 945 min[947.13–1013.30], respectively; p<0.0001). Postoperative analgesia alsolasted significantly longer in group L compared to group R (1320 min[1273.4–1321.8] vs. 840 min [759.23–812.77]; p<0.0001]). Patients in group Lhad significantly better visual analogue scale (VAS) score and lesserconsumption of analgesics (p<0.0001). None of the groups developed anyadverse effect over the observation period. Levobupivacaine provides prolongedpostoperative analgesia in sciatic nerve block with reduction in postoperativeanalgesic consumption.

  **REFERENCES**

1.    Blanco R. Optimal point ofinjection: The quadratus lumborum type I and II blocks. Anaesthesia2014:1550.

2.    Schuenke MD, Vleeming A, Van HoofT, Willard FH. A description of the lumbar interfascial triangle and itsrelation with the lateral raphe: Anatomical constituents of load transferthrough the lateral margin of the thoracolumbar fascia. J Anat2012;221:568-76.

3.    Willard FH, Vleeming A, SchuenkeMD, Danneels L, Schleip R. The thoracolumbar fascia: Anatomy, function andclinical considerations. J Anat 2012;221:507-36.

4.    Nair A. Bilateral quadratuslumborum block for post-caesarean analgesia. Indian J Anaesth2017;61:362-3

5.    Kadam VR. Ultrasound-guidedquadratus lumborum block as a postoperative analgesic technique for laparotomy.J Anaesthesiol Clin Pharmacol 2013;29:550-2.

6.    Akerman M, PejÄić N, VeliÄkovićI. A Review of the Quadratus Lumborum Block and ERAS. Front Med (Lausanne).2018 Feb 26;5:44.

7.     Hesham Elsharkawy, KariemEl-Boghdadly, Michael Barrington; Quadratus Lumborum Block: AnatomicalConcepts, Mechanisms, and Techniques. Anesthesiology 2019; 130:322–335

8.    Malav K, Singariya G, Mohammed S,Kamal M, Sangwan P, Paliwal B. Comparison of 0.5% Ropivacaine and 0.5%Levobupivacaine for Sciatic Nerve Block Using Labat Approach in Foot and AnkleSurgery. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):15-20.

9.    Kuthiala G, Chaudhary G.Ropivacaine: A review of its pharmacology and clinical use. Indian J Anaesth.2011 Mar;55(2):104-10.

10.                       Fleiss, StatisticalMethods for Rates and Proportions, formulas 3.18 &3.19.

11.                       Ã–ksüz G, Arslan M,UrfalıoÄŸlu A, et al. Comparison of quadratus lumborum  block and caudal block for postoperative  analgesia in pediatric patients undergoinginguinal hernia repair and orchiopexy surgeries: A randomized controlled trial.Reg Anesth Pain Med 2020; 45:187-191.

12.                       Kumar GD, Gnanasekar N, Kurhekar P, Prasad TK. A ComparativeStudy of Transversus Abdominis Plane Block versus Quadratus Lumborum Block forPostoperative Analgesia following Lower Abdominal Surgeries: A ProspectiveDouble-blinded Study. Anesth Essays Res. 2018 Oct-Dec;12(4):919-923.

13.                       Deng W, Long X, Li M,Li C, Guo L, Xu G, Yu S. Quadratus lumborum block versus transversus abdominisplane block for postoperative pain management after laparoscopic colorectalsurgery: A randomized controlled trial. Medicine (Baltimore). 2019Dec;98(52):e18448.

14.                       WangY, Hu H, Feng C, Liu D, Ding N. Effect of Ultrasound-Guided Quadratus LumborumBlock Preemptive Analgesia on Postoperative Recovery of Patients with OpenRadical Colon Cancer Surgery: A Retrospective Study. Cancer Manag Res. 2021 Sep1;13:6859-6867.

15.                       Murouchi, T, Iwasaki, Sand, Yamakage, M. Quadratus lumborum block: analgesic effects and chronologicalropivacaine concentrations after laparoscopic surgery. Reg Anesth Pain Med2016; 41: 146–150.

16.                       Malav K, Singariya G,Mohammed S, Kamal M, Sangwan P, Paliwal B. Comparison of 0.5% Ropivacaine and0.5% Levobupivacaine for Sciatic Nerve Block Using Labat Approach in Foot andAnkle Surgery. Turk J Anaesthesiol Reanim. 2018 Feb;46(1):15-20.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-09
• Last Update Posted: 2023-08-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

Patients giving written consent will be taken Patients of either sex aged 18-65 years ASA I-II patients scheduled to undergone.

Exclusion Criteria

Local infection at site of block Cardiovascular disease H/o allergy to study medications known hypersensitivity to LA body mass index ≥35 kg/m2, ≤16kg/m2 history of opioid addiction bleeding diathesis renal and hepatic dysfunctions pregnancy.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To study duration of analgesia i.e. time needed for first rescue analgesia in postoperative period.	To study duration of analgesia i.e. time needed for first rescue analgesia in postoperative period.

Secondary Outcome Measures

Name	Time	Method
Total rescue analgesic consumption in postoperative period	Postoperative pain scores using the visual analog scale (VAS) for pain at rest in the postoperative period at 0, 1, 6, 12, and 24 hours.

Trial Locations

Locations (1)

Department of Anaesthesiology Trauma Ventilatory Unit; 🇮🇳 Lucknow, UTTAR PRADESH, India

Department of Anaesthesiology Trauma Ventilatory Unit

🇮🇳Lucknow, UTTAR PRADESH, India

Prof Reetu Verma

Principal investigator

9473641975

reetuverma1998@gmail.com