Decreasing the leakage of continuous femoral nerve catheter fixation using 2 - octyl cyanoacrylate glue ( Demabond® ): A Randomized Controlled Trial study

doi:10.21203/rs.3.rs-41791/v2

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Decreasing the leakage of continuous femoral nerve catheter fixation using 2 - octyl cyanoacrylate glue ( Demabond® ): A Randomized Controlled Trial study

https://doi.org/10.21203/rs.3.rs-41791/v2

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Background : Continuous peripheral nerve catheters (CPNCs) have been used for postoperative pain relief. The common problem with CPNCs is pericatheter leakage that can compromise the sterile dressing, un-necessitating frequent dressing that may increase the risk of dislodgement and perineural catheter colonization or infections. Adhesive glue is useful for fixing peripheral nerve catheter as well as prevent leakage around the puncture site. This study aimed to evaluate the incidence of pericatheter leakage by using fixation with 2 -octyl cyanoacrylate glue (Demabond) compared to sterile strip.

Methods : Thirty patients undergoing unilateral total knee arthroplasty and received continuous femoral nerve block were randomized to perineural catheter fixation with 2-octyl cyanoacrylate glue or sterile strip. The primary outcome was the incidence of pericatheter leakage. Secondary outcomes included frequent of catheter migration, difficulty of catheter removal, pain score and patient satisfaction.

Results : The incidence of pericatheter leakage at 48 hours was 0% versus 100% in the intervention and control group. The incidence of displacement at 24 and 48 hours was 6.7% versus 93.3% and 6.7% versus 100%, respectively (P < 0.001). There was no difference in numeric rating scale, difficulty of catheter removal as well as satisfaction scores between groups.

Conclusion : Catheter fixation with 2-octylcyanoacrylate reduced the incidence of pericatheter leakage as well as catheter displacement over 48 hours compare to sterile strip.

Anesthesiology & Pain Medicine

Continuous peripheral nerve catheters

pericatheter leakage

catheter displacement

Dermabond

Continuous peripheral nerve catheters (CPNCs) have been used for sustained postoperative pain relief with opioid sparing effect, improved rehabilitation and patient well being (1-3). The challenging to maintain CPNCs function is to secure in the correct position especially in the freely mobile sites, such as the neck or limb region. Moreover, the technique should prevent pericatheter leakage that may increase risk of dislodgement, colonization and infection (4). Several methods to secure catheters have been studied, such as suturing, cutaneous suture (5) and retrograde subcutaneous tunneling (6). However, accidental dislodgment and pericatheter leakage are still a frequent problem.

In our institute, we mainly place catheters using the catheter-through-needle method. As it helps us to confirm the tip position after the surgery by using nerve stimulator. Since the needle is larger than the catheter size, thereby, pericatheter leakage is a significant problem in our patient. Having a simple, non-invasive, reliable method for catheter fixation and preventing dislodgment would be beneficial. Previous studies (7-10) showed that adhesive glue was an effective method for peripheral nerve catheter fixation; however, leakage around the pericatheter was only their secondary outcome. Therefore, we conduct a single-center, randomized controlled study to evaluate the incidence of pericatheter leakage by using sterile stripe or 2-ocylcyanoacrylate (Dermabond®) in continuous femoral catheter. We hypothesized that fixing the continuous femoral nerve catheter with 2-ocylcyanoacrylate (Dermabond®) would reduce the incidence of pericatheter leakage within 48 hours. The secondary outcomes were catheter migration, numeric rating scale score (NRS), difficulty of catheter removal, and patient satisfaction with analgesia.

Study participants

After receiving approval by the Ramathibodi hospital research ethics board. This trial was registered on Thai clinical trial registry: TCTR20200228002, registered 24 February 2020- Retrospectively registered, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=lsresult&task=search&task2=ls. Reporting of this study was done by adhering to the Consolidated Standards of Reporting Trials (CONSORT) statement for reporting of randomized trial. Written informed consent was obtained from all participants. We enrolled 30 adult patients aged 40–80 years, with American Society of Anesthesiologists physical status I-IV who were scheduled to undergo total knee arthroplasty (TKA). We excluded patients who refused to participate in the study, those with localized infection at the inguinal area of the operated leg and patient who contraindicate to femoral nerve block or allergy to local anesthetic drug/ adhesive glue.

Randomization

Our research coordinator who was not involve in the study performed computer-generated simple 1:1 ratio to 2-octyl cyanoacrylate glue (Demabond®) (Dermabond group) or normal practice fixation (Control group). Allocation of patients to each group was concealed in a sealed envelope. The anesthesiologist who performed femoral nerve block open the envelope just before the time of block performance.

Femoral nerve block performance

For patients undergoing unilateral TKA, femoral sheath catheters were inserted pre-operatively using a nerve stimulator. A Stimulong® continuous nerve block set 18-gauge 50 mm Tuohy needle and 20-gauge catheter). After sterile preparation and draping of the femoral area on the operative side, stimulation at 2 Hz and 1.5 mA was applied after the needle was felt to have gone through two fascial planes, 1.5 cm lateral to the femoral artery. When quadriceps contraction was detected, the current was decreased, and the needle position was optimized for evident contraction at a current output of 0.2–0.5 mA. The Stimulong® catheter was attached to the nerve stimulator and the catheter slowly thread until a depth of 3–5 cm from the needle tip while maintaining quadriceps contraction at a current ≤ 0.5 mA. The catheter was repositioned as necessary to sustain continuous quadriceps contraction at a current ≤ 0.5 mA. The needle was withdrawn, and the patients were divided into the following 2 groups: Dermabond group; catheter is sealed with 2-octyl cyanoacrylate liquid adhesive (Dermabond®), and the area is covered with transparent dressing (Tegaderm^TM) (figure 1). Control group; catheter is secured with sterile strip to secure the catheter, and the area is covered with transparent dressing (Tegaderm^TM) (figure 1).

The patients were then transferred to the operating room for spinal anesthesia. We perform spinal anesthesia using a 27-gauge quicke needle with a solution of isobaric Marcaine 10–15 mg at the second to the fourth lumbar level. No local anesthetics were given through the femoral catheter during surgery. In the recovery room, the patients were given a 15-mL bolus of bupivacaine 0.125% injected through the femoral catheter. The femoral catheter was then infused with bupivacaine 0.08% at 5 mL/h. Every patient received acetaminophen 100mg (every 6 hours) and naproxen 250 mg (every 8 hours) for 3 days. If patient had postoperative pain score more than 4, morphine 3 mg were administered as rescue analgesia.

Outcomes

The primary outcome was the leakage at the catheter site, classified as

Mild; fluid was around the catheter, < 1 cm from the insertion site

Moderate; fluid was around the catheter, > 1 cm from the insertion site but still in the transparent dressing (Tegaderm^TM). Severe; fluid out of the transparent dressing (Tegaderm^TM)

The secondary outcomes, which included catheter migration, difficulty of catheter removal, and patient satisfaction, were assessed by the acute pain service nurse at postanesthetic care unit (PACU), 24 h and 48 h postoperative period.

Statistical Methodology

Demographic characteristics of the subjects in each randomized controlled study were analyzed. Continuous variables are reported using mean and standard deviation values or median and range values. Categorical variables are presented using counts and percentages and tested using Chi-Square or Fisher exact test, as appropriate. Continuous variables were tested for normality with the Shapiro-Wilk test. T test or Mann-Whitney test were used for group comparisons as appropriate. P-value < 0.05 implied statistical significance. The statistical software SPSS 20.0 for Windows was used for data analyses.

The sample size was calculated assuming a catheter leakage rate of 50% with standard fixation techniques based on previous literature (9) and institutional pilot data to have at least 80% power to see a clinically relevant reduction to zero percentage with a 2-sided type I error rate of 0.05. A sample size of 11 subjects in each arm of each group was considered adequate. Additional 4 subjects per groups were recruited to prevent loss of power because of early withdrawal or protocol violations. Thus, 15 subjects per group was the derived sample size.

After screening and randomization, there were 30 patients included and final analysis. The CONSORT flow diagram is shown in figure 3. In both group, there was no significant difference in the sex, age, body mass index (BMI), and ASA physical status of the subjects in the two groups (Table 1). The incidence of pericatheter leakage at 48 hours was 0% in dermabond group and 100% in control group. The incidence of catheter displacement was lower in dermabond group compare to control group (At 24 hours: 6.7% versus 73.3%, P <0.001, 48 hours: 6.7% versus 93.3%) as well as incidence of CPNCs dressing change. There were no different in 24 and 48-hours numerical rating scale (NRS) between group (24 hours NRS 2 (0-7) versus 2 (0-8), P= 0.54), 48-hours NRS 2 (0-7) versus 2 (0-7), P=0.81) as well as satisfaction score (Satisfaction score: Dermabond vs. control group: 9.13 ± 1.13 vs 9.07 ± 1.28, P = 0.881) (Table 2). In both group, there was no incidence of dislodgement as well as difficulty of catheter removal.

This prospective randomized trial study reveals a significant improvement of pericatheter leakage by using 2-octylcyanoacrylate (Dermabond®) fixation compare with sterile strip. It also prevents the occurrence of catheter displacement and dressing changes frequency while maintain high quality pain control and satisfaction score.

Two -octylcyanoacrylate (Dermabond®) is a liquid monomer that spontaneously polymerizes in the presence of moisture to create a waterproof bond with the surrounding epidermis. Several studies have compared this surgical adhesive against suture for the closure of lacerations in both trauma and elective surgery. Therefore, many studies have been evaluated efficacy of dermabond on CPNCs.

Gurnaney et al. reported the incidence of pericatheter leakage before and after introduce dermabond as a catheter fixation protocol in all type of CPNCs. They found the percentage reduction in incidence of catheter leakage from 3.87% to 0.56% (11). David B et al. conducted a study compared fixation continuous interscalene catheter with Dermabond® and Mastisol, a liquid medical adhesive, under catheter through needle technique. However, the incidence of pericatheter leakage was only their secondary outcome. They found that Dermabond group had incidence of peri-catheter leakage at 24 and 48 hours 3% (1/31) and 0% (0/27), P-value < 0.001. Moreover, patient in dermabond group had lower incidence of catheter migration than Mastisol group (91% vs. 65%, P-value 0.012).

Our study shows consistency results. However, the lower incidence in our study may explain by our study experimented on femoral CPNCs while previous study studied in interscalene CPNCs. We hypothesized that at neck region potentially increase risk of mobility than the groin region. Moreover, our study did not include the incidence of leakage or dislodgment over than 48 hours. As our post-operative knee replacement protocol stop local anesthetic infusion on postoperative day 2 to enhance patient muscle strength for ambulate with an assistive device. Therefore, our incidence of leakage or dislodgment are unable to reported over than 48 hours. From our experience perspective, we found that using Dermabond fixation on CPNCs provide significant reduction in incidence of leakage as well as dislodgement.

This prospective randomized trial systematically followed perineural catheter leakage in continuous femoral nerve block that is lower extremities block over 48 hours after total knee arthroplasty. These resulted reveals that Dermabond was significantly more effective in preventing perineural catheter leakage than the conventional method using sterile strip. Moreover, the use of Dermabond involved reduced pericatheter bleeding from the puncture site. There was no difficulty in catheter removal, suggesting that despite a waterproof bond with the epidermis, Dermabond does not increase the difficulty of catheter removal at the time of planned discontinuation. Even though the cost of Dermabond is higher than that of the sterile strip. The indirect costs of failed CPNBs from the effect they might have on the clinical outcomes and nursing care may be higher. In this study, we found no leakage in the Dermabond group; thus, there was no need to change the dressing and meant less nursing care. From the result, fixation CPNCs with Dermabond may be useful in ambulatory setting. Since the incidence of pericatheter leakage or dislodgment may reduce and therefore, require less patient self-care or dis-comfort at home.

Our study has some limitations. First, the assessor and patient were not blinded to the fixation technique in the study, potentially contributing to observer bias in the study. However, our leakage or displacement criteria are objective evaluation. Therefore, the potentially bias may reduce. Secondly, there are several perineural catheter systems available in the market, and these results may not be generalizable to all types of peripheral nerve block catheters, such as catheter over needle technique. Since our institute mainly place catheters using the catheter-through-needle method. Therefore, we have high incidence of pericatheter leakage. We found fixation catheter with dermabond significantly prevent occurrence of pericatheter leakage. Third, the results of our study were obtained from a single center, which has vast experience in catheter care process, and the results must be considered when attempting in different clinical setting.

Fixation catheter with 2-octylcyanoacrylate (Dermabond®) reduced the incidence of pericatheter leakage as well as catheter displacement over 48 hours in a continuous femoral block when compared to sterile strip.

BMI: Body mass index

CPNCs: Continuous peripheral nerve catheters (CPNCs)

NRS: Numeric rating scale score

PACU: Post anesthetic care unit

TKA: Total knee arthroplasty

Ethics approval and consent to participate

Written informed consent was obtained from all participants. The study was approved by the Ramathibodi hospital research ethics board. This trial was registered on Thai clinical trial registry: TCTR20200228002, registered 24 February 2020- Retrospectively registered, http://www.clinicaltrials.in.th/index.php?tp=regtrials&menu=trialsearch&smenu=lsresult&task=search&task2=ls.

Consent for publication: Not applicable

Availability of data and materials:

The datasets during and/or analyzed during the current study available from the corresponding author on reasonable request.

Competing interests: The authors declare that they have no competing interests

Funding: Not applicable

Authors' contributions

Conceptualization: T.C., V.A.; Methodology: L.S., T.C.; Formal analysis and investigation: T.C., L.S., R.B.; Writing - original draft preparation: T.W., V.A., L.S.; Writing - review and editing: T.W.

Acknowledgements: Not applicable

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Chelly JE, Ghisi D, Fanelli A. Continuous peripheral nerve blocks in acute pain management. Br J Anaesth 2010; 105: i86-96.
Capdevila X, Bringuier S, Borgeat A. Infectious risk of continuous peripheral nerve blocks. Anesthesiology 2009; 110:182–8
Klein SM, Greengrass RA, Gleason DH, Nunley JA, Steele SM. Major ambulatory surgery with continuous regional anesthesia and a disposable infusion pump. Anesthesiology. 1999;91(2):563-5.
Borgeat A, Tewes E, Biasca N, Gerber C. Patient-controlled interscalene analgesia with ropivacaine after major shoulder surgery: PCIA vs PCA. British journal of anaesthesia. 1998;81(4):603-5.
David B. Auyong, MD, David Asher Cantor, MD, Cynthia Green, PhD, and Neil A. Hanson, MD. The effect of fixation technique on continuous interscalene nerve block catheter success: A randomized, double-blind trial. Anesth Analg 2017; 124: 959-965
Klein SM, Nielsen KC, Buckenmaier CC III, Kamal AS, Rubin Y, Steele SM. 2-Octyl cyanoacrylate glue for the fixation of continuous peripheral nerve catheters. Anesthesiology 2003; 98: 590-1.
Switzer EF, Dinsmore RC, North JH Jr. Subcuticular closure versus Dermabond: a prospective randomized trial. Am Surg. 2003; 69:434-436.
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Table 1 Patient’s demographic data

	Dermabond group (15)	Control group (15)	P-value
Male/Female, n	0/15	3/12	0.224
Age (y), mean ± SD	68.2 ± 7.5	66.33 ± 6.77	0.48
BMI (kg.m⁻²), mean ± SD	25.99 ± 3.67	27.41 ± 3.26	0.272
ASA I/II/III, n	0/8/7	1/8/6	>0.999

Data are represented as median (minimum-maximum) or as indicated in the table.

Table 2 Catheter and subject related outcomes for Dermabond compared with control group

	Dermabond group	Control group	P-value
Leakage, n (%)
24 h after operation	0 (0%)	14 (93.33%)	< 0.001*
Mild	-	2 (13.33%)
Moderate	-	2 (13.33%)
Severe	-	10 (66.67%)
48 h after operation	0 (0%)	15 (100%)	< 0.001*
Mild	-	2 (13.33%)
Moderate	-	1 (6.67%)
Severe	-	12 (80%)
Displacement, n (%)
24 h after operation	1 (6.67%)	11 (73.33%)	< 0.001*
48 h after operation	1 (6.67%)	14 (93.33%)	< 0.001*
Change dressing, n (%)
24 h after operation	0	1(0-3)	0.001
48 h after operation	0	1(0-4)	<0.001
NRS
24 h after operation	2 (0–7)	2 (0–8)	0.539
48 h after operation	2 (0–7)	2 (0–7)	0.806
Satisfaction score, mean ± SD	9.13 ± 1.13	9.07 ± 1.28	0.881

Table 2 Catheter and subject related outcomes for Dermabond compared with control group

	Dermabond group	Control group	P-value
Leakage, n (%)
*24 h after operation*	0 (0%)	14 (93.33%)	< 0.001*
Mild	-	2 (13.33%)
Moderate	-	2 (13.33%)
Severe	-	10 (66.67%)
*48 h after operation*	0 (0%)	15 (100%)	< 0.001*
Mild	-	2 (13.33%)
Moderate	-	1 (6.67%)
Severe	-	12 (80%)
Displacement, n (%)
24 h after operation	1 (6.67%)	11 (73.33%)	< 0.001*
48 h after operation	1 (6.67%)	14 (93.33%)	< 0.001*
NRS
*24 h after operation*	2 (0–7)	2 (0–8)	0.539
*48 h after operation*	2 (0–7)	2 (0–7)	0.806
Satisfaction score, mean ± SD	9.13 ± 1.13	9.07 ± 1.28	0.881

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Review #2 received at journal
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Decreasing the leakage of continuous femoral nerve catheter fixation using 2 - octyl cyanoacrylate glue ( Demabond® ): A Randomized Controlled Trial study

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Abstract

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Background

Methods

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