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Intrathecal use of clonidine with hyperbaric bupivacaine in orthopaedic surgeries of lower limb.

INTRODUCTION: Lower limb orthopedic surgeries are preferably done under central neuraxial blockade mainly sub-arachnoid block for short duration surgeries. Bupivacaine is the standard local anesthetic for sub-arachnoid block for these surgeries. For prolongation of regional anesthesia, adjuvants are added to local anesthetics like opioids, [[alpha].sub.2] agonists, epinephrine etc.

Clonidine is a frequently used adjuvant to local anesthetics (LA). The analgesic properties of clonidine when administered intrathecally or epidurally have been demonstrated; Moreover, others have indicated an increased incidence of adverse effects like sedation, hypotension and bradycardia. (1-3)

Clonidine has been shown to be of benefit for use in central neuraxial blocks and other regional blocks by increasing the duration and intensity of pain relief (4, 5) as also by decreasing the systemic and local inflammatory stress response. (6-8)

So, we decided to study Intrathecal effects of clonidine with hyperbaric bupivacaine in patients undergoing lower limb orthopedic surgeries.

METHODS: After institutional approval and informed written consent, a prospective randomized study was conducted on 60 adult patients undergoing lower limb orthopedic surgeries. Patients aged between 18 to 70 years, of either gender, height of 150 to 170 cms, ASA physical status 1 or 2 were included in our study and were divided into two groups, group 1: bupivacaine with saline (BS) and group 2: bupivacaine with clonidine (BC). Patients excluded are those with contra-indications for subarachnoid block, patients with significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease or alcohol or drug abuse, and pregnant or lactating women. Patients taking medications with psychotropic or adrenergic activities and patients receiving chronic analgesic therapy were also barred from the study.

All patients were evaluated in the pre-anesthetic clinic. Any specific investigations, if required according to the individual cases were also done. Patients were familiarized with visual analogue scale (VAS) (9) and its use for measuring the postoperative pain. All patients were fasted overnight for 8 to 10 hrs. and received Tab Alprazolam 0.5 mg as premedication a night before and 0.25 mg in morning on the day of the surgery.

Intraoperative: In the operation theatre all patients were again explained about the procedure and use of VAS; and electrocardiogram (ECG), pulse oximetry, and non-invasive blood pressure were attached and baseline parameters were recorded and monitoring was initiated. Intravenous (IV) access was secured and all patients were preloaded with ringer lactate 10 ml/kg. Patients were randomly assigned using sealed envelope technique into two groups BS and group BC.

Under strict aseptic precautions, patient in sitting position, lumbar puncture was performed with the patient in the sitting position at the [L.sub.3-4] or [L.sub.2-3] interspace, with a 24-gauge Quincke-point needle. Group BS were injected with 12.5 mg 0.5% hyperbaric bupivacaine with 0.2 mL of normal saline and group BC injected with 12.5 mg of 0.5% hyperbaric bupivacaine with 30 [micro]g (0.2 mL) of clonidine after ensuring free flow of clear CSF.

The following parameters were assessed and compared:

* Time for onset of sensory block and adequate level of analgesia (T10, assessed with pinprick).

* Time for onset of motor block assessed by modified Bromage scale. (10)

* Peak sensory level reached (assessed with pinprick)

* Time at two segment regression from peak level of sensory block.

* Time for motor block to recede to L 3-4 level, ability to flex knee

* Duration of sensory block.

* Incidence of complications including--respiratory depression, hypotension, bradycardia, nausea and vomiting, sedation, shivering and mandatory bladder catheterization within 12 hours.
Sedation scale

0   No sedation (awake and alert)
1   Drowsy
2   Asleep, responding to verbal commands
3   Asleep, not responding to verbal commands


The cephalad spread of analgesia and the degree of motor blockade of the lower limbs was recorded every 5 minutes. The level of sensory blockade was assessed using a 25 gauge short bevel needle and recorded as analgesia to loss of sensation to pin prick. Motor blockade was determined according to the modified Bromage score (10)

0--No paresis--the patient is able to move the hip, knee, and ankle;

1--Partial paresis--the patient is unable to move the hip, but is able to move the knee and ankle;

2--Partial paresis--the patient is unable to move hip and knee, but is able to move the ankle;

3--Complete paresis--the patient is unable to move the hip, knee, and ankle.

Complete motor block recovery was assumed when modified Bromage score was 3.

The parameters such as heart rate, non-invasive blood pressure, ECG and Sp[O.sub.2] were periodically monitored and recorded at 5 minutes interval. A note was also made of blood loss, urine output, IV fluid input. Patients were observed for any discomfort, nausea, vomiting, shivering, pain, bradycardia and any other side effect and the need for additional medications was recorded.

IV fluid was administered in the form of Ringer's lactate, in calculated doses depending on the weight of the patient and further adjusted as per blood loss during surgery. A fall of systolic arterial blood pressure (SBP) to less than 90 mm of Hg or fall below 30% of baseline value was treated with rapid infusion of 500 ml of RL and 3 mg aliquots of injection mephentermine intravenously if there was no response to fluid administration. Bradycardia (heart rate less than 50/minute) was treated with intravenous atropine sulphate (0.6 mg). For patients with shivering, cotton roll and blankets were used.

All patients were observed in the post-anesthesia recovery room and then in the ward. Severity of pain was measured using a 10 cm visual analogue scale (VAS) at 0, 1/2, 1, 2, 4, 6, 12 and 24 hour intervals for next 24 hours by the nursing staff. If patient has VAS of >3 or complains of pain with VAS >3 were given rescue analgesia by injection Diclofenac sodium 75 mg intramuscularly. The time of onset of pain was recorded and frequency of rescue analgesia required in each case was recorded.

The various data obtained, which included the hemodynamic parameters, respiratory rate, Sp[O.sub.2], duration of analgesia were calculated and compared with baseline values within each group as well as with corresponding times among the groups, using paired t-test and students t-test respectively. A 'P' value <0.05 was taken as significant.

RESULTS: Both the groups were comparable in terms of age, gender, height and weight (Table 1). Table 2 shows the number of patients in two groups undergoing different types of lower limb surgeries. The duration of surgery between the groups was almost similar according to the type of procedure performed and clinically comparable.

In group BC, the onset of sensory block was slower compared to the group BS. The onset of sensory block was defined as the time between injection of intrathecal anesthetic and the absence of pain at the T12 dermatome assessed by sterile pinprick every 2 min till T10 dermatome was achieved. The onset of motor block was also delayed in group BC compared to group BS, but onset of both sensory and motor block between groups were statistically insignificant.

The mean duration of analgesia was 140.26 minutes in group BC compared to 93.63 minutes in group BS. Similarly, mean duration of motor block was 153.74 minutes in group BC compared to 104.79 minutes in group BS. The duration of sensory block and motor block was prolonged in group BC compared to group BS, which was both clinically and statistically significant (p < 0.001).

On overall the duration of spinal anesthesia was prolonged in patients who received intrathecal clonidine with bupivacaine. The total number of Diclofenac injections received over 24 hour post operatively was significantly lower in clonidine group compared to saline group.

The blood pressure were comparable between the groups with one patient having hypotension in group BS compared to two patients in group BC, but in rest of the patients of group BC had comparable values as group BS. Two patients in group BC had bradycardia requiring treatment with injection atropine. There was no significant change in respiratory rate and Sp[O.sub.2] from the baseline values in both the groups.

None of the patients experienced respiratory distress at any point of time. All patients had peripheral oxygen saturation (Sp[O.sub.2]) greater than 96% at all the times and did not require additional oxygen in PACU. One patient in group BC had nausea and was treated with intravenous injection of Ondansetron 4 mg. In group BS, one patient had shivering intraoperatively as compared to none of the patients in group BC.

DISCUSSION: Clonidine, a selective partial agonist at [[alpha].sub.2] adrenergic receptors is known to produce analgesia after intrathecal administration mediated through activation of post synaptic [[alpha].sub.2] receptors in substantia gelatinosa of spinal cord. When used as an adjuvant to local anesthetics it is known prolong both sensory and motor blockade, but dose at which it produced above effect in previous studies have been known to produce side effects like hypotension, bradycardia and sedation. (11, 12)

Total duration of sensory block in our study was 140.26 minutes which is in accordance with study by Hema Saxena et al (13) and was less compared to study by Ramila R Jamliya et al, (14) may be due to the dose of bupivacaine used in our study (12.5 mg) but in terms of prolongation of duration of sensory block was in accordance with above studies.

Clonidine group in our study had delayed onset of both sensory and motor block which was not statistically significant compared to the study by Gandhe et al (15) and Ramila R Jamliya et al (14) who had similar result but significant statistically.

I. Van Tuijl et al (16) studied use of clonidine 75 [micro]g with hyperbaric bupivacaine in 53 pregnant patients, and found 58% of the study group patients had hypotension compared to 6% to 7% of patients in our study probably due to use of 75 [micro]g clonidine in their study (comparison to 30 [micro]g). Even though they have used 11 mg of hyperbaric bupivacaine in their study compared to 12.5 mg bupivacaine in our study.

Even though, incidence of hypotension and bradycardia were present in clonidine group, other side effects of intrathecal clonidine was comparable to other previous studies; one of patient had sedation which was not significant, similar to study by I. van Tuijl et al (16) but was significant in study by B.S. Sethi et al (12), and similar to these earlier studies, no patient had incidence of respiratory depression.

One patient in control group had shivering compared to none in study group was not significant. One patient in clonidine group had nausea requiring treatment probably due to hypotension in the same patient. None of patient had urinary retention similar to previous studies.

In consistent with most of studies on intrathecal use of clonidine with hyperbaric bupivacaine, B.S.Sethi el al, (12) Saxena et al, (13) Kaabachi et al, (17) Elia et al, (18) Cao JP, (19) our study showed prolongation of analgesia and significantly less requirement of rescue analgesics over 24 hour study period at 30 [micro]g of clonidine in comparison to much higher doses of intrathecal clonidine in previous studies, significantly reducing hemodynamic side effects. Using clonidine in place of opioids avoids side effects related to them like pruritus, urinary retention and respiratory depression.

We conclude that addition of 30 [micro]g of clonidine to 0.5% hyperbaric bupivacaine intrathecally can prolong the sensory and motor blockade, and duration of analgesia without much hemodynamic adverse effects.

DOI: 10.14260/jemds/2014/2320

REFERENCES:

(1.) Dobrydnjov I, Axelsson K, Samarutel J, Holmstrom B. Postoperative pain relief following intrathecal bupivacaine combined with intrathecal or oral clonidine. Acta Anaesthesiol Scand 2002; 46: 806-14

(2.) Eisenach JC, De Kock M, Klimscha W. Alpha (2)-adrenergic agonists for regional anaesthesia. A clinical review of clonidine (1984-1995). Anesthesiology 1996; 85: 655-74

(3.) Chiari A, Lorber C, Eisenach JC, et al. Analgesic and hemodynamic effects of intrathecal clonidine as the sole analgesic agent during first stage of labor: a dose-response study. Anesthesiology 1999; 91: 388-96

(4.) Elia N, Culebras X, Mazza C, Schiffer E, Tramer MR. Clonidine as an adjuvant to intrathecal local anesthetics for surgery: Systematic review of randomized trials. Reg Anesth Pain Med 2008; 33:159 67.

(5.) Bhatnagar S, Mishra S, Madhurima S, Gurjar M, Mondal AS. Clonidine as an analgesic adjuvant to continuous paravertebral bupivacaine for post-thoracotomy pain. Anaesth Intensive Care 2006; 34: 586-91.

(6.) Gabriel JS, Gordin V. Alpha 2 agonists in regional anaesthesia and analgesia. Curr Opin Anaesthesiol 2001; 14:751-3.

(7.) Persec J, Persec Z, Husedzinovic I. Postoperative pain and systemic inflammatory stress response after preoperative analgesia with clonidine or levobupivacaine: a randomized controlled trial. Wien Klin Wochenschr 2009; 121: 558-63.

(8.) Romero-Sandoval A, Eisenach JC. Clonidine reduces hypersensitivity and alters the balance of pro and anti-inflammatory leukocytes after local injection at the site of inflammatory neuritis. Brain Behav Immun 2007; 21: 569-80.

(9.) Katz J, Melzack R. Measurement of pain. Surg Clin North Am 1999; 79:231 52.

(10.) Bromage PR. A comparison of the hydrochloride and carbon dioxide salts of lidocaine and prilocaine in epidural analgesia. Acta Anaesthesiol Scand Suppl 1965;16:55-69

(11.) Chiari A, Eisenach JC, Spinal anaesthesia: Mechanisms, agents, methods, and safety. Reg Anesth Pain Med 1998; 23: 357-62.

(12.) Sethi BS, Samuel M, Sreevastava D. Efficacy of analgesic effects of low dose intrathecal clonidine as adjuvant to bupivacaine. Ind Jrnl of Anaesth 2007; 51:415-19.

(13.) Hema Saxena, S. Singh & S. Ghildiyal. Low dose intrathecal clonidine with bupivacaine improves onset and duration of block with hemodynamic stability. Internet Journal of Anesthesiology. 2010; Volume 23, Number 11.

(14.) Jamliya DRH, Vansola DR, Shah DBJ, Chauhan DL. Effect of Clonidine Addition to Hyperbaric 0.5% Bupivacaine for Spinal Anaesthesia in Lower Limb Surgery [A Comparative Study], NJIRM 2012; 3(1): 113-119.

(15.) Grandhe RP, Wig J, Yaddanapudi LN. Evaluation of bupivacaine-clonidine combination for unilateral spinal anaesthesia in lower limb orthopedic surgery, J Anaesth Clin Pharmacology 2008; 24(2): 155.

(16.) Van Tuijl I, Giezeman MJ, Braithwaite SA, Hennis PJ, Kalkman CJ and Van Klei W A. Intrathecal low-dose hyperbaric bupivacaine-clonidine combination in outpatient knee arthroscopy: a randomized controlled trial. Acta Anaesthesiology Scand 2008; 52(3): 343-349.

(17.) Kaabachi O, Zarghouni A, Ouezini R, Abdelaziz AB, Chattauuoi O, Kokki H. Clonidine 1mcg/kg is a safe and effective adjuvant to plain bupivacaine in spinal anaesthesia in adolescents. Anesthesia and Analgesia 2007; 105 (3): 516-519.

(18.) Elia N, Culebras X, Mazza C, Schiffer E and Tramer MR. Clonidine as an adjuvant to intrathecal local anaesthetics for surgery: Systematic review of randomized trials. Regional Anesthesia and Pain Medicine 33(2):159-167.

(19.) Cao JP, Miao XY, Liu J and Shi XY. An evaluation of intrathecal bupivacaine combined with intrathecal or intravenous clonidine in children undergoing orthopedic surgery: a randomized double-blinded study. Pediatric Anesthesia 2011; 21(4):399-405.

Chandrashekharappa K [1], Ravindra C. G [2], Kumara A. B [3], Kiran M [4]

AUTHORS:

[1.] Chandrashekharappa K.

[2.] Ravindra C. G.

[3.] Kumara A. B.

[4.] Kiran M.

PARTICULARS OF CONTRIBUTORS:

[1.] Associate Professor, Department of Anaesthesiology, Shivamogga Institute of Medical Sciences, Shivamogga.

[2.] Assistant Professor, Department of Anaesthesiology, Shivamogga Institute of Medical Sciences, Shivamogga.

[3.] Senior Resident, Department of Anaesthesiology, Shivamogga Institute of Medical Sciences, Shivamogga.

[4.] Assistant Professor, Department of Anaesthesiology, Shivamogga Institute of Medical Sciences, Shivamogga.

NAME ADDRESS EMAIL ID OF THE CORRESPONDING AUTHOR:

Dr. Chandrashekharappa K, Kavi Nivas, 100 Feet Road, Rajendra Nagar, Shimoga--577204.

E-mail: dr.chandrukavi@gmail.com

Date of Submission: 05/03/2014.

Date of Peer Review: 06/03/2014.

Date of Acceptance: 21/03/2014.

Date of Publishing: 01/04/2014.
Table 1: Demographic Profile

                      Group BS              Group BC         p-value

Age in years     53.8 [+ or -] 18.64   52.7 [+ or -] 15.85   0.8064
Gender--                17:13                 20:10          0.4257
  male: female
ASA physical            14:16                 12:18          0.6023
  status
  (1 or 2)
Height in        156.8 [+ or -] 5.4    160.6 [+ or -] 6.6    0.01773
  centimetres
Weight in        60.6 [+ or -] 10.8    58.8 [+ or -] 12.6    0.5548
  kilograms
Duration         112.2 [+ or -] 24.4   106.8 [+ or -] 32.2   0.4671
  of surgery
  in minutes

Table 2: Type of lower limb surgeries

Type of lower                              Group BS
limb surgeries
                                    MALE   FEMALE   Total

1. Dynamic Hip Screw fixation        5       3        8
2. Fracture Tibia for OR+IF          2       1        3
3. Fracture Shaft of femur OR+IF     5       4        9
4. Tension Banding Wiring of         1       0        1
   patella fracture
5. Bi/Tri-Malleolar fracture         1       1        2
   of ankle
6. Fracture neck of Femur-           3       4        7
  Austin Moore Prosthesis
TOTAL                                17      13      30

Type of lower                              Group BC
limb surgeries
                                    MALE   FEMALE   Total

1. Dynamic Hip Screw fixation        4       4        8
2. Fracture Tibia for OR+IF          2       1        3
3. Fracture Shaft of femur OR+IF     5       2        7
4. Tension Banding Wiring of         5       0        5
   patella fracture
5. Bi/Tri-Malleolar fracture         4       2        6
   of ankle
6. Fracture neck of Femur-           0       1        1
  Austin Moore Prosthesis
TOTAL                                20      10      30

Table 3: Adverse events

Adverse events              Group BS    Group BC

Bradycardia                     0       2 (6.67%)
Hypotension                 1 (3.33%)   2 (6.67%)
Nausea/ vomiting                0       1 (3.33%)
Sedation score: 2 or more       0       1 (3.33%)
Shivering                   1 (3.33%)       0

Table 4: Characteristics of subarachnoid block

Characteristics                    Group BS            Group BC

                              Mean    Standard     Mean    Standard
                                      Deviation            Deviation

Time of onset of              3.99      0.95       4.12      0.63
  sensory block
Time of onset of              4.60      0.98       4.77      0.63
  motor block
Time of sensory block        93.63      12.19     140.26     16.29
  for 2 segment regression
Time of regression of        104.79     13.77     153.74     16.71
  motor block
Time of first rescue         102.19     13.23     169.57     18.12
  analgesic given

Characteristics              p-value   significance

Time of onset of              0.515        Not
  sensory block                        significant
Time of onset of              0.435        Not
  motor block                          significant
Time of sensory block        <0.001    Significant
  for 2 segment regression
Time of regression of        <0.001    Significant
  motor block
Time of first rescue         <0.001    Significant
  analgesic given
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Title Annotation:ORIGINAL ARTICLE
Author:K., Chandrashekharappa; G., Ravindra C.; B., Kumara A.; M., Kiran
Publication:Journal of Evolution of Medical and Dental Sciences
Article Type:Report
Date:Apr 7, 2014
Words:3040
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