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The Effect of Spinal Introducer Needle (20-Gauge) use on Postoperative Back Pain, Postural Dural Puncture Headache and Patient Satisfaction

*Correspondence to: Luiz Eduardo Imbelloni MD, PhD, Anesthesiologist Complexo Hospitalar Mangabeira, Rua Marieta Steimbach Silva, João Pessoa,PB – Brazil, E-mail: dr.imbelloni@hotmail.com

Article Information

Article Type: Research

Received : 21.11.2018 
Accepted : 03.12.2018 
Published : 10.12.2018

Abstract

BACKGROUND:The goal of this randomized study was to compare the incidence of postdural puncture headache (PDPH) and postoperative puncture backache (POPB), and the success rate between two small-gauge spinal needle designs used in orthopedic undergoing subarachnoid block anesthesia.

METHODS:After Institutional Review Board approval, 80 patients presenting for orthopedic surgery were randomly assigned to have 27G Whitacre with introducer or 26G Quincke spinal needles used in their spinal anesthesia. The number of attempts to successful cerebrospinal fluid return and the success rate of the spinal blockade were documented. Postoperatively, an investigator blinded to the study interviewed patients daily. The cost of needles was evaluated.

RESULTS:The two groups were similar. Sixty patients (75%) of both groups did not need to redirect the needles. There is no significant difference between groups. Intervertebral space was changed in the introducer group in 6 patients (15%) while in the control group in 3 patients (7.5%). There was no significant difference between the groups. There was an accidental perforation of the dura mater with the introducer, resulting in post-perforation headache.The incidence of PDPH was similar between both needles. There was a significant difference between the groups with regard to the incidence of backpain on the 1st and 7th postoperative day. All patients reported satisfaction with spinal anesthesia regardless of the technique used. The Quincke 26G needle costs R$ 9.00 reais (US$ 2.39) and Whitacre 27G with a 20G introducer R$ 15.00 reais (US$ 3.98).

CONCLUSION:Both 27G Whitacre with introducer and 26G Quincke needles have excellent handling characteristics. POPB is less common withthe 26G Quincke needle than with the Whitacre with introducer needle.

KEYWORDS:Whitacre needle, Introducer needle, Quincke needle, orthopedic surgery, postdural puncture back pain, postdural puncture headache, Spinal anesthesia.

 

Article

INTRODUCTION

Backache is a common public health problem and a major psychological, physical and economical burden for the individual and the society [1]. Backache is a frequent complaint after neuraxial anesthesia. However, neuraxial anesthesia may not be the sole cause. Postanesthesia backache occurs with equal frequency after either spinal (21%) or general anesthesia (19%) [2].

To access the subarachnoid space we can do it in two ways: the first consists of passing a small gauge spinal needle through skin and ligaments; this may promote a less traumatic puncture but can result in a fine gauge needle being bent and misdirected [4-6]. The second approach uses a large introducer needle to penetrate the skin and fibrous layers. The fine gauge spinal needle can then pass through the larger introducer needle with less resistance, guided by the stiffer needle’s shaft, toward the diameter[4,5]. The use of a large bore introducer needle may cause tissue trauma, inflammation and late epidermoid tumors[7].

Previous study suggested that patients did not experience any back pain after placement of a spinal anesthesia with a large 18-gauge introducer [8]. The purpose of this investigation was to compare the severity of postoperative back pain (POBP), postural dural puncture headache (PDPH) and patient satisfaction scores after the administration of a spinal anesthetic with or without the use a 20-gauge introducer needle.

METHODS

Afterregistrationin the BrazilPlatform(CAAE: 34743214.9.0000.5179), approval by the Ethics ResearchCommittee (171.924) andsigning of theinformedconsent, a double-blindrandomizedprospective studywas performed in patientsASAphysicalstatusI andII(AmericanSociety of Anesthesiology), aged between 18and 50 years old, weighing between 50 and80 kgof both sexesindicated fororthopedic surgeryof the lower limbs.Patients with heartorrespiratory disease, mental disorder, neurological disease, sensitivity toanesthetic,anticoagulanttherapy, history of back pain, preoperative opioid, refusal of or contraindication subarachnoid block were excluded.Failure of blocking are excluded and replaced according to protocol.

The hospital performs around 300 orthopedic lower limb surgeries per month. Usinga significance levelof 5% and amargin of error of0.10,sample sizeobtainedwas 62patients.Eighteen patients were addedwith a totalsample of 80patientsin twogroups of 40patients.The draw was performed using random sampling with replacement in two subgroups, through an EXCEL random number generator.

The patients were divided into two groups by random computersystem support: Group Experimental (Whitacre 27G and passed through the introducer needle 20G, 0.90x35 mm - B. Braun Melsunger, Germany) and Group Control (Spinocan® 26G B. Braun Melsunger, Germany). Patients were blinded tostudy. Anesthesiologists were blinded to the study needle useduntil a patient randomized on the study. The study coordinatorthat collected data was blinded to groups throughout the study.On the day of surgery, the anesthesiologist opened the envelopesthat stored randomized sequence numbers in the operatingroom to not change patients’ allocation. A 27-gauge Whitacre needle was passed through the introducer needle to puncture the dura. The control group had a 26-gauge Quincke needle placed without the use of an introducer needle. Both the experimental group (introducer) and control group the received infiltration from the needle pathway to the spinal puncture with 1 mL of lidocaine in insulin syringe.

As part of program Acerto, the patient drank a single 200 mL carbohydrate beverage orally (12.5% dextrin maltose). The patients fasted for at least 2 to 4 hours after sent to the operating room. Thepatients did not receive any pharmacological premedication in the room.

After venous puncturewith20-gaugecatheterwas started,infusionof Ringer'slactate solution began. Monitoring in theoperating roomconsisted of continuousECGusing the CM5 lead, blood pressure bynon-invasive methodandpulse oximetry.

After administrationof midazolam (1 mg) and fentanyl (1 µg/kg), level of sedation was assessed(Table1)[5].With aseptic precautions, subarachnoid block was performed using a 27G Whitacre or 26G Quinckespinal needle with local infiltrationof 1 mL of lidocaine with insulin syringe. The desired volume of 0.5% isobaric bupivacaine was injected intrathecally and was confirmed by theappearance ofcerebrospinalfluid (CSF).The spinal anesthesia wasperformed to all patients by onea 3rd year resident with excellent experience in spinal anesthesia.

During lumbar puncture, the number of needle redirects (without=0, 1 or > 2), needle deformation, need for intervertebral space exchange, accidental perforation of the dura mater by the introducer, and block failure were evaluated. The redirection was defined as removing the needle from the spine without reaching the skin in order to change direction and move to the desired location.The postoperative analgesia was performed through the anterior lumbar plexus block (inguinal) or sciatic block with a HNS12 Neuroestimulator, obtained the desired contraction, a 0.25% levobupivacaine solution (Cristália Chemical and PharmaceuticalLtd.) were injected.In the postoperative period, patients were observed in the postanesthetic care room for 1–2 h. All patients were mobilized after total return of motor block assessed by anesthesiologist. The cost of both needles was assessed.

Patient follow-up was performed by telephone and all were questioned on the 1st and 7th postoperative day on the development of low back pain and headache in this period. Patient satisfaction with the anesthetic technique was also evaluated.

The Kruskal-Wallis test was used to evaluate the difference between the quantitative variables. For the qualitative variables, the Chi-square test with Monte Carlo simulation was used, the value of p

RESULTS

The two groups were similar in relation to age, weight, height, and gender and ASA state physical(Table II).After use of fentanyl and midazolam in the operating roomall patients remained oriented and able to answer simple questions throughout the surgical procedure.

The number of redirects of the needle is described in Table 3. Sixty patients (75%) of both groups did not need to redirect the needles. Using the Kruskal-Wallis test there is no significant difference between groups.

Intervertebral space was changed in the introducer group in 6 patients (15%) while in the control group in 3 patients (7.5%). Using the Chi-square test there was no significant difference between the groups (P-Value=0.2885).

The deformation of the needle occurred in 3 patients (7.5%) in the experimental group and in only 1 patient (2.5%) in the control group. Using the chi-square test there was no significant difference between the groups (P-Value=0.3049).

Of the 80 patients included in this study, three presented block failure in the experimental group. These were deleted and replaced, according to the protocol. There was an accidental perforation of the dura mater with the introducer, resulting in post-perforation headache.

The incidence of 24-hour and 7-day back pain is shown in Table IV. Using the chi-square test there was a significant difference between the groups.

Both groups presented 5% of headache, and in the experimental group, one case was secondary to accidental perforation of the dura mater. All patients reported satisfaction with spinal anesthesia regardless of the technique used.

The Quincke 26G needle costs R$ 9.00 reais (US$ 2.39) and Whitacre 27G with a 20G introducer R$ 15.00 reais (US$ 3.98).

DISCUSSION

Postdural puncture backache is the most frequent postoperative complaint after spinal anesthesia [9]. This investigation found significant difference in the back pain between those patients who received spinal anesthesia with the use of a 20G introducer needlecompared to spinal needle cut point 26G, in both groups local infiltration with 1 mL of lidocaine was used prior to puncture in the studied group and in the control group.

The introducer was a needle device designed by Sise in the 1920s for use with needles available at the time and was in regular use until early 90's, 

when the disposable introducers [10] were introduced. The Sise introducer resembled a large pin with 5 cm cannulated shaft and with the cutting edge. The currently available introducers seem to be built more specifically for the types of needles in use, like the present study.The skin-to-extradural-space distance was recorded for 3,011 women in labour[11]. However, this measure was not found in non-obstetric patients. The introducers can be of different sizes (18G, 20G and 22G) and also their length depends on the manufacturer.Some authors recommend that the introducer not be introduced more than 2 cm to avoid accidental puncture of the dura mater, which corresponds a sufficient distance to facilitate penetration of the needle [12].In this study an accidental perforation occurred with the introducer causing PDPH.

Postoperative puncture backache (POPB) which is characterizedby continuous pain around the site of spinal puncture withoutany irradiation is also a common complaint after spinal anesthesia[13].The mechanism attributed to the onset of back pain may be injury or trauma to the ligaments, fasciae, bones, small bleeding or injury of the nerve roots in the cauda equina [14]. The type and duration of surgery, position of the patient during the puncture, and the immobilization time on the operating table affect the pathogenesis of postdural puncture back pain. The incidence of back pain decreased from 29% on 1st postoperative to 5% 4 weeks after the spinal [15],with a decrease in incidence and intensity.In our study, the proportion of back pain of the patients was found as 15% in the 1st day and 20% in the 7th of Control Group (Quincke) and 30% and 35% respectively of Introducer Group. We found the incidence of POPB was lower in both groups according to other studies.

The control group, assigned to receive spinal anesthesia without the use of the 20G introducer needle, did not experience a significantly higher number of redirections, different from another study when using the 18G introducer needle [8]. The redirections were most likely due to the fine gauge spinal needle bending as it passed through the fibrous spinal ligaments. This fact did not happen in this study, since 75% of the patients had no need for redirections of both the introducer and 27G Whitacre and the 26G Quincke needle.

The introducer needle does carry the risk of accidental Dural puncture [16,17], and this complication occurred in only one patient, resulting in post-puncture headache of the dura mater.This investigation was performed with a 3rd year resident with excellent experience in spinal anesthesia guided by a preceptor with 44 years of anesthesia practice. The level of anesthesia training no represented a limitation of this investigation. 

The limitation of our study was that we were unableto obtain information about the patients’ preoperativebackache history. Thus, prospective studies with homogeneous groupsare necessary, with meticulous history of the patients’backaches recorded prior to operations, to establish thisdifference clearly. Asecond limitation of this investigation is the small number of women enrolled. Previous investigation has reported conflicting results as to the influence of sex on the incidence of POPB[18]. 

The cost of a Quincke type needle is US$ 2.39 and aWhitacre with introducertype needle nearly US$ 3.98 in our country. Hence, the use ofQuincke needles can be a cost‑effective choice.

CONCLUSIONS

Multiple factors are involved in the pathogenesis of POPB and include type and duration of surgery, duration of immobilization, and the position of the patient during spinal puncture.The diagnosis of back pain is not simple. There is no statistically difference regarding the incidence of postural dural puncture headache between Whitacre with introducer and Quincke needles in orthopedic patients. However, in relation to the appearance of back pain on the 1stand7th postoperative day there is a greater incidence with the use of the introducer. There is no statistically difference regarding technical ease of use between Whitacre and Quincke needles in orthopedic patients. Both spinalneedles (Whitacre or Quincke needles) are suitable according tothe preference and the need of physician. The cost‑effectiveness’ may be an advantage for Quincke type needles.

 

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