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Role of Clonidine in Fascia Iliaca Compartment Block for Preoperative Analgesia in Post Hip Fracture Patients: A Comparative Study | OMICS International
ISSN: 2155-6148
Journal of Anesthesia & Clinical Research

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Role of Clonidine in Fascia Iliaca Compartment Block for Preoperative Analgesia in Post Hip Fracture Patients: A Comparative Study

Gaurav Singh Tomar*, Akhilesh Tiwari, Shankar Agrawal, Ashish Sethi, Kriplani TC and Neeraj Singh Gaur

Department of Anesthesiology & Critical care, Sushruta Trauma Centre, New Delhi, India

*Corresponding Author:
Gaurav Singh Tomar
Department of Anesthesiology & Critical care
Sushruta Trauma Centre, New Delhi, India
E-mail: [email protected]

Received date: December 25, 2010; Accepted date: February 14, 2011; Published date: February 15, 2011

Citation: Tomar GS, Tiwari A, Agrawal S, Sethi A, Kriplani TC, et al. (2011) Role of Clonidine in Fascia Iliaca Compartment Block for Preoperative Analgesia in Post Hip Fracture Patients: A Comparative Study. J Anesthe Clinic Res 2:121. doi: 10.4172/2155-6148.1000121

Copyright: © 2011 Tomar GS. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

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Abstract

Background: Fractures around the hip joint are associated with considerable moderate to severe pain. Adequate preoperative analgesia in these patients is difficult to assess and often an overseen aspect of their care. This study was aimed to assess the efficacy of adding clonidine as adjuvant in fascia iliaca compartment block (FICB) in relieving pain and increasing the pain free duration in the preoperative period.

Methods: Sixty patients were divided into three groups of 20 each. Patients in group A received 40 ml of 0.25% bupivacaine + 100μg clonidine and patients in group B received 40 ml of 0.25% bupivacaine + 50μg clonidine whereas group C (the control group) patients were given only 40 ml of 0.25% bupivacaine. Changes in heart rate and blood pressure were recorded in each group.

Results: There was significant improvement in VAS and Sitting Score in both the groups after the block and the findings of paired t test on VAS at 1Hr, 2Hr, 6Hr was comparable (P>0.05) but showed significant difference the next morning (P<0.05). The patients of group A had a total pain free sleep of more than 12 hrs after the block.

Conclusion: The results suggest that 100μg clonidine is superior to 50μg clonidine and the control group and is the appropriate dose in fascia iliaca compartment block and provides significant benefit in terms of pain relief at rest as well as during transportation and more importantly also facilitates positioning required for proper imaging in the preoperative period.

Keywords

Clonidine; Analgesia; Fascia iliaca compartment block (FICB)

Introduction

Hip fractures can cause considerable pain when untreated or under treated that justifies preoperative control. Since surgery is very often delayed for more than 24 hours for a variety of reasons in these patients [1] and fracture immobilization can also be a very difficult task without proper analgesia, providing satisfactory analgesia is a major challenge while patients await surgery. This pain can be alleviated by a simple fascia iliaca compartment block that can be performed at the bedside without the need of a nerve stimulator. [2,3] FICB is a feasible, efficient pre-operative supplement to conventional pain-treatment for patients with hip fractures.

Fascia iliaca compartment block endeavors to block the femoral nerve, lateral femoral cutaneous nerve of thigh and obturator nerve in a single shot given deep to Fascia iliaca. This is a simple block for pre and post-operative pain relief for injuries involving the hip, anterior thigh, and knee.

The α2 agonists are assuming greater importance as anesthetic adjuvants and analgesics. Their primary effect is sympatholytic. Clonidine hydrochloride, is a centrally acting α2 agonist hypotensive agent. Several experimental and clinical studies have shown that it was able to prolong the duration of action of local anesthetics or to produce analgesia after central and peripheral neuraxial administration. [4,5,6,7,8]

The aim of this study was to evaluate whether addition of clonidine to bupivacaine prolongs the duration of action of bupivacaine as compared to placebo, and to apply this to a clinical setting such as fractures around the hip joint where the importance of providing satisfactory analgesia cannot be overemphasized. Our intention was also to find out whether this goal could be be accomplished after a simple single shot fascia iliaca compartment block Where clonidine by prolonging the action of bupivacaine can obviate the need of catheter, otherwise needed to provide continuous analgesia.

Materials and Methods

60 patients of ASA class I - II were randomly assigned by random computer generated method to one of the three groups:-

Group A: 20 patients received 0.25% plain bupivacaine 40ml + clonidine 100 µg.

Group B: 20 patients received 0.25% plain bupivacaine 40ml + clonidine 50 µg .

Group C: 20 patients received 0.25% plain bupivacaine 40 ml only.

Both the groups A and B were compared with group C as a controlled group.

Patients were explained regarding the possible risks and complications before taking written consent. After securing i.v access with appropriate cannula, all the patients were preloaded with 10 ml/kg of ringer's lactate within 30 minutes before the block. No premedication was given.

Patient was positioned supine on the bed and proper illumination was given at the site of the block.

Study type- Cross sectional double blind hospital based study.

Study duration- 15th april 2010 to 15th july 2010.

Study subjects- 60 patients admitted in the orthopedic wards with fractures involving the hip were selected for the study.

Sampling technique- Time Based Simple Random Sampling.

Selection of sample- During the study duration I came across around 200 cases and out of them 60 elderly patients of either sex were selected for the study by using simple random sampling .

. Inclusion criteria- Clinical criteria of hip fracture as assessed by the resident on call orthopedics and patient should have intact cognitive status on admission.

. Exclusion criteria- Patient having allergy to local anesthetics, bleeding diathesis, infection at the injection site, previous surgery in affected hip, any major substance abuse and refusal on consent agreement were excluded from this study.

Ethical consideration: After obtaining approval for conducting this study from the institutional ethics committee, the present study was conducted in the department of Anesthesiology and Critical care, N.S.C.B. Medical College, Jabalpur (M.P.). Informed consent was obtained after properly explaining the procedure.

Data collection: For the collection of sample all the variables were assessed and a pretested semi structured performa was used containing information regarding sociodemographic details of patient variables.

. Preoperative data collection- A complete pre-anaesthetic evaluation was carried out, baseline pulse rate, blood pressure, respiratory rate and Sp02 were recorded.

. Post-block monitoring- all the patient were monitored intermittently at the interval of 15 minutes for the first 1 hour; 30 min for the next 2 hours and 1 hourly subsequently follow up manually for blood pressure and with pulse oximetry for pulse and Sp02.

Data processing and analysis: After collection of data, they were put in excel sheet and SPSS 17th version and later on got analyzed with the help of colleuges and all departmental members.

Statistical tests which were used to analyze the data of this study were:

Independent student t-test, Turkey Kramer - Multiple comparison test.

Landmarks: The line joining the pubic tubercle to anterior superior iliac spine is divided into three equal parts. The site of insertion is 1cm below the junction of lateral one third and medial two third of this line, which at least 2cm lateral to the femoral artery.

A short beveled 23G needle was then vertically introduced 1cm below the union of lateral one third with the medial two third, which at least 2cm lateral to the femoral artery. During needle insertion two pops i.e. loss of resistance sought. The first one occurs as the tip of needle crosses the fascia lata, and the second one occurs as the fascia iliaca is pierced.

After piercing fascia iliaca attach the syringe to the needle aspirate, if nothing comes then inject drug 0.25% plain bupivacaine (Sensorcaine 0.25% - Astra Zeneca) 40ml + clonidine (Cloneon - Neon Lab.) 100µg or 50µg according to the group injecting a sufficient volume and massaging the swollen area favor the spread of solution to the inner surface of fascia iliaca, improving the chances to block distant lumber plexus nerves such as obturator nerve.

Pain was assessed using visual analogue scale and objective sitting scale before the block and at 1hr, 2hr, 6hr, 12hr and next morning after the block respectively. Level of sedation was assessed by using sedation scale. Throughout the period of block pulse rate and Sp02 was monitored continuously and blood pressure half hourly.

Pain intensity was evaluated by using a 10cm visual scale, one End(0 point of VAS) of which shows no pain and other end (10 point of VAS ) worst possible pain. [9] This does have its limitations, but for all practical purposes, it is the easiest and simplest type.

Sedation was assessed by using the sedation score described by Culebras et al. [10] which was graded as follows:

1. Awake and alert

2. Sedated, responding to verbal stimulus

3. Sedated, responding to mild physical stimulus

4. Sedated, responding to moderate or severe physical stimulus

5. Not arousable .

The effectiveness of the block was assessed by using an Objective Sitting Scale described by Candal Couto JJ [1] which is as follows:

Score 1= if the patient could only lie flat or use a maximum of two pillows because of pain,

Score 2=if the patient could become semi-recumbent and was able to tolerate more than two pillows,

Score 3=if the patient was able to sit upright with the support of many pillows and could reach a glass of water on the (Table 1) across the bed,

Demo. Paramtrs. Intervention Groups Control group
Mean age (± S.D.) Group A
56.8(±12.72)
Group B
57.6(±13.76)
Group C
57.2(±10.20)
Mean body wt. (± S.D.)   52.62(±4.84)   53.02(±3.80)   51.86(±4.68)
Sex No. % No. % No. %
Male 13 65 12 60 11 55
Female 7 35 8 40 9 45

Table 1: Demographic data distribution of patients.

Score 4=if the patient was able to sit up in bed independently without support and was able to lean forward to reach an object down the bed.

Results

There were no significant intergroup difference with regards to gender distribution, age and weight. Mean VAS before the block in group A, B and C were (8.15±1.2), (7.96±1.34) and (8.02±1.14) which decreased to (3.35±0.78), (3.4±0.83) and (4.24±0.32) respectively after the block (Table 2). The extent of reduction in the VAS in the groups A and B were almost the same. In this study VAS at 12 hours, the next morning and after 24 hours in intervention groups A and group B were (4.4±0.85), (4.5±0.86), (5.12±0.30) and (4.6±0.86), (4.8±0.91), (5.86±0.32) respectively ;while in control group C, VAS reduced to just (5.62±0.42), (6.71±0.31) and (7.51±0.40) respectively.

  baseline 1 hr 2hr 6hr 12hr Next morning After 24 hrs.
VAS Score
Group A
Group B
Group C
8.15±0.51 3.35±0.17 3.40±0.18 4.30±0.23 4.4±0.24 4.5±0.25 5.12±0.30
7.96±0.49 3.4±0.18 3.6±0.20 4.3±0.23 4.6±0.27 4.8±0.27 5.86±0.32
8.2±0.5 4.5±0.25 4.7±0.26 5.3±0.30 5.8±0.35 6.1±0.40 7.51±0.40
Sedation Score
Group A
Group B
Group C
1.0±0.0 3.2±0.16 2.9±0.14 2.6±0.12 2.4±0.11 2.25±0.10 1.74±0.12
1.0±0.0 2.5±0.12 2.3±0.10 2.0±0.09 1.85±0.08 1.75±0.08 1.42±0.10
1.0±0.0 1.0±0.0 1.0±0.0 1.0±0.0 1.0±0.0 1.0±0.0 1.0±0.0
Sitting Score
Group A
Group B
Group C
1.5±0.0 3.2±0.16 3.25±0.16 3.0±0.14 2.6±0.12 2.5±0.11 2.25±0.10
1.5±0.0 2.9±0.13 2.9±0.13 2.5±0.12 2.4±0.11 2.3±0.10 2.0±0.80
1.5±0.0 2.5±0.12 2.4±0.11 2.1±0.09 1.9±0.08 1.82±0.09 1.64±0.06

Table 2:

anesthesia-clinical-research-fascia-iliaca

Figure 1: Landmarks of fascia iliaca compartment block.

Sedation was assessed by using the sedation score described by Culebras et al [10] Mean sedation score was 1 in all the groups before the block (Table 2). Next day morning, patients that received 100µg Clonidine were considerably more sedated (mean sedation score 2.25±0.26) than the group that received 50µg Clonidine (mean sedation score 1.75±0.30) while no sedation seen in patients of group C.

Sitting score using objective sitting scale at end of 12 hr, next day morning and after 24 hrs in intervention groups A, B were (2.6±0.12), (2.5±0.11), (2.25±0.10) and (2.4±0.11), (2.3±0.10), (2.0±0.80) respectively while in control group C score was just (1.9±0.08), (1.82±0.09) and (1.64±0.06) respectively.

Patient vitals including pulse rate, blood pressure and arterial saturation before and after the block at regular intermittent monitoring follow ups remained as invariable.

Discussion

The present study was conducted to evaluate the effect of Clonidine added to Bupivacaine on post hip fracture analgesia after fascia iliaca compartment block. Our intention was to find out whether this goal can be accomplished after a single shot fascia iliaca compartment block and whether addition of clonidine to bupivacaine prolong the duration of analgesia to such an extent (16 - 18 hours) that it can obviate the need of catheter, otherwise needed to provide continuous analgesia in such a setting.

We performed the study as a prospective case series and as the mean age of patient was 57.2 years there was no evidence of cognitive impairment in any of the patients taken up for the study. Patient vitals including pulse rate, blood pressure, arterial saturation before and after the block at regular intermittent monitoring follow ups remained unaffected, proving its safety in elderly age group.

The mean age of the study groups was comparable. Overall mean age 57.2 was less in comparison to study of Monzon DG et al. [11] i.e.,73.5 years and Høgh A et al. [12] which was 80.7 years. This may be attributed to early osteoporosis due to poor nutrition in patients of low socioeconomic class that visit this hospital.

In order to achieve a more objective measurement of block effectiveness, we then measured the patient's ability to sit up by using objective sitting score. With this novel functional assessment we found that the block reliably improved the patient's ability to sit up and pain free periods.

The extent of reduction in the VAS in the two intervention groups were almost the same when compared to VAS before the block as compared to the control group. In this study VAS at 12 hours, the next morning and after 24 hours in group A were 4.4, 4.5 and 5.12 respectively and in group B it was 4.6, 4.8 and 5.86 respectively while in group C, VAS reduced to 5.6, 6.7 and 7.51 which was statistically significant indicating that addition of Clonidine prolongs the duration of analgesia as compared to the studies of Candal-Couto JJ et al. [1] and of Monzon DG et al. [11] in which analgesia lasted for about 7-8 hours. There study excluded patients with intracapsular fractures.

In this study with the addition of clonidine improved duration of pain relief in all patients having intracapsular as well as extracapsular fracture and benefit lasts up to 16-18 hours.

Monzon DG et al. [11] studied single shot fascia iliaca compartment block with bupivacaine alone and needed rescue analgesia with oral diclofenac after 8 hours but in this study we did not need any rescue analgesia with the addition of clonidine to bupivacaine.

Improvement in the ability to sit upright provided by fascia iliaca compartment block may aid patient care in the preoperative period. Objective sitting score as described by Candal-Couto JJ et al. [1] in 2005 was used which showed no significant difference up to 6 hours in both group A and B. Sitting score at 12 hours and next morning in group A showed statistically significant difference compared to group B and group C indicating addition of 100 µg Clonidine effectively prolongs the duration of analgesia. In our study duration of analgesia was seen even beyond 24 hours but effectively up to 16-18 hours in group A i.e. with 100 µg Clonidine and it's up to 10-12 hours in group B i.e. with 50 µg Clonidine while this was just effective up to 5-6 hours in control group C i.e. without clonidine.

Prolongation of analgesic action of bupivacaine by clonidine in vivo is unclear and not mediated by an a-adrenergic mechanism but attributed to its direct inhibitory effect on peripheral nerve conduction by A and C fibres [13].

Side effects associated were dose limiting. None of the patient reported bradycardia, hypotension and dry mouth after successful completion of block in any group. These side effects are more commonly seen with clonidine dose higher than 100 µg. Sedation was an only side effect of clonidine adjunct observed in intervention groups A and B, not with the control group C. Sedation was assessed by using the sedation score described by Culebras et al. [10] Mean sedation score was 1 in both the groups before the block (Table 2). The patients that received 100µg Clonidine were considerably more sedated (mean sedation score 2.25) than the group that received 50 µg Clonidine (mean sedation score 1.75). We continuously measured the oxygen saturation to detect any respiratory depression secondary to sedation and found that there was no significant desaturation at any time and although more sedation occurred with addition of 100µg Clonidine than with addition of 50µg Clonidine, it served a useful purpose as it aided initiation of restful sleep in patients, who were in considerable agony and stress before the block.

Our results were in accordance with other studies highlighting the usefulness of a variety of nerve blocks of the lumbar plexus and its descendent nerves in the management of patients with hip fracture.

Major limitation of this study could be that it was conducted on small scale by taking smaller sample sizes, if it was carried out at large scale and by taking larger sample sizes like randomized controlled trial, then the results and conclusions would be more generalizable and implicable. Another limitation of our study could be we didn't measure serum concentration of clonidine so as to rule out the possibility of add on systemic effects of clonidine contributing to its analgesia due to its absorption from the local site of injection.

Conclusion

Addition of clonidine enhanced pain relief. Addition of both 100 µg and 50 µg clonidine to bupivacaine increases the duration of analgesia. Novel findings in this study were that after successful completion of block, addition of 50 µg clonidine produces effective analgesia up to 10- 12 hours as compared to control group C in which effect last up to 5-6 hours without Clonidine while addition of 100µg clonidine produces effective pre-emptive analgesia up to 16-18 hours that may even reaches up to 24 hours with acceptable range of side effects in patients of extra capsular as well as intra capsular hip fractures.

As far as safety profile is concerned addition of Clonidine usually associated with sedation, bradycardia and hypotension, but in our study we found that there was no bradycardia or hypotension noted with both 50 & 100 µg clonidine. Although sedation was more with 100 µg than 50 µg clonidine, but it served a useful purpose as it aided initiation of restful sleep in patients, who were in considerable agony and stress before the block.

Thus we conclude that clonidine adjunct in appropriate dose in single shot fascia iliaca compartment block is a feasible and effective method of pre-emptive analgesia for patients with hip fractures with a minimal risk approach and acceptable safety profile.

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