Intrathecal dextmedetomidine to reduce shoulder tip pain in laparoscopic cholecystectomies under spinal anesthesia.

BACKGROUND: General anesthesia as a technique for laparoscopic cholecystectomies has disadvantage in terms of the stress response, lack of postoperative analgesia and emesis. Regional anesthesia offers advantages over general anesthesia in terms of cost, postoperative analgesia, intact respiratory control mechanism and early ambulation. Shoulder tip pain remains the main concerns that can be alleviated by adding various adjuvants to local anesthetics. AIMS AND
OBJECTIVES: To study the effect of adding intrathecal dexmedetomidine to bupivacaine to decrease shoulder tip pain, onset and duration of sensory and motor block, hemodynamic changes and side effects if any.
MATERIALS AND METHODS: Totally, 60 patients were divided into two groups of 30 each. Group A received 3 ml of bupivacaine heavy and group B received 5 µg of dexmedetomidine along with 3 ml of bupivacaine diluted to total volume of 3.5 ml in each group. STATISTICAL ANALYSIS: It was done using Chi-square and Student's t-test. RESULTS AND
CONCLUSIONS: Intrathecal dexmedetomidine provides stable hemodynamics, excellent sedation and analgesia and abolishes shoulder tip pain.

RCT Entities:   Population Interventions Outcomes

INTRODUCTION

Laparoscopy is one of the most common surgical procedures and is the procedure of choice for most of the elective abdominal surgeries performed preferably under endotracheal general anesthesia. Technical advances in the field of laparoscopy have helped to reduce surgical trauma and discomfort, reduce anesthetic requirement resulting in short hospital stay. General anesthesia as the only suitable technique for laparoscopy procedure is a concept of the past as it does not facilitate adequate postoperative analgesia or an emesis postrecovery, two important problems associated with laparoscopy surgeries. The goal of anesthetic management in these patients includes management of pneumoperitoneum, achieving adequate level of sensory blockage, management of shoulder tip pain and early ambulation. Subarachnoid blocks fulfill these criteria and aids in quick and uneventful postoperative recovery. Stress response and incidence of deep vein thrombosis are reduced under regional techniques. The respiratory control mechanism remains intact to allow patients to adjust their minute ventilation and maintain an unchanged ETCO2.

Although general anesthesia is considered the choice of anesthesia for laparoscopy, regional anesthesia in the form of spinal anesthesia, epidural anesthesia and or combined spinal epidural provide unique advantages over general anesthesia.[123] The only limiting factor for use of spinal anesthesia in laparoscopy is patient's discomfort with pneumoperitoneum and the associated shoulder tip pain.[45678]

Spinal anesthesia is the most commonly used technique for lower abdominal and lower limb surgeries as it is very economical and easy to administer. Various adjuvants have been added to intrathecal local anesthetic agents, adrenaline being the first and the latest being dexmedetomidine. Intrathecal α2 agonists when used as adjuncts potentiate the effect of local anesthetics and allows a decrease in required doses of local anesthetics.[910111213141516] Clonidine is a partial α2 agonist used intrathecally with well-established efficacy and safety. It prolongs the duration of motor and sensory spinal blockade when used along with local anesthetics.[910111213141516]

Several studies have been conducted to decrease shoulder tip pain in laparoscopy under spinal anesthesia.[456] Intrathecal opioids have been tried in combination with local anesthetics for spinal anesthesia but postoperative nausea, vomiting, and pruritus have been the limiting factors for their use. Studies have been conducted using intrathecal clonidine in doses up to 1 µg/kg.[91011] These doses are associated with sympatholytic side effects of clonidine such as bradycardia and hypotension along with analgesic effects. Many studies have been conducted to evaluate the effect of intrathecal clonidine in the concentration of 1 µg for laparoscopy and its efficacy to attenuate shoulder tip pain.[17]

Dexmedetomidine is new highly selective α2 adrenoceptor agonist and has been approved by Food and Drug Administration as intravenous (iv) sedative and co-analgesic drug. Its α2/α1 selectivity is 8 times higher than clonidine.[7] Also, studies have been conducted analyzing the effect of intrathecal dexmedetomidine when combined with bupivacaine in spinal anesthesia.[18192021] However, not much literature is available regarding the use of intrathecal dexmedetomitine with bupivacaine to reduce shoulder tip pain in laparoscopic cholecystectomies. Therefore, we decided to analyze the effect of intrathecal dexmedetomidine in the dose of 5 µg to reduce the shoulder tip pain when combined with intrathecal bupivacaine for laparoscopic cholecystectomies.

On the basis of previous studies,[17181920212223242526] our hypothesis was that intrathecal dexmedetomidine 5 µg or clonidine 1 µg would be equipotent and would produce a similar effect on the characteristics of bupivacaine in spinal anesthesia. The purpose of this study was to compare the incidence of shoulder tip pain, onset and duration of sensory and motor block, the hemodynamic changes, quality of postoperative analgesia, incidence of postoperative nausea and vomiting and complications if any following intrathecal bupivacaine versus intrathecal bupivacaine supplemented with 5 µg dexmedetomidine.

MATERIALS AND METHODS

The present study was conducted after obtaining a valid written and informed consent. Approval from the Institutional Ethics Committee was obtained for the study.

Inclusion criteria were as follows:

American Society of Anesthesiologists (ASA) grades I and II patients

Age: 18–50 years, either sex

Surgery: Elective laparoscopic cholecystectomies.

Exclusion criteria were as follows:

ASA grade >II

Age: <18 or >50 years

Patients' refusal

Patients using α2-adrenergic receptors antagonists, calcium channel blockers, angiotensin converting enzyme inhibitors

Dysrhythmia

Body weight more than 120 kg

Height >140 cm

Postspinal surgeries, spinal deformity

History of allergy to study drugs

Pregnancy

Coagulopathy

Neurological disorders

Known contraindications to spinal anesthesia.

All patients were examined a day before surgery and were kept fasting overnight. They received injection glycopyrrolate 0.2 mg and injection ondansetron 8 mg iv as premedication. In the operation theater, patient's baseline pulse, blood pressure (BP), saturation, ETCO2, respiratory rate (RR), and electrocardiography (ECG) were recorded and all were preloaded with ringer lactate 15 ml/kg. These patients were randomly assigned using a sealed envelope technique into two groups in a double-blind manner. Sample size was decided in consultation with statistician and the power was calculated to be >85%. Group A (n = 30) received 3.0 ml of heavy bupivacaine with normal saline (NS) to make 3.50 ml and group B received 3.0 ml of bupivacaine along with dextmedetomidine 5 µg to make a total volume of 3.50 ml.

Spinal anesthesia was given in the lateral position in L3-L4 interspace with 26 gauge Quincke's needle. The anesthesiologist giving spinal anesthesia was blinded to the solution being administered intrathecally. Patients were made supine and following parameters were noted: Time of the onset of sensory block as assessed by pinprick, onset of motor block assessed using Bromage scale, two-segment regression and the time when patient demanded rescue analgesia. The operating table was adjusted to achieve a sensory level of maximum T4 in all patients. Intraoperative pulse, BP, RR, SpO2, ETCO2 by a side stream capnometer placed at the nostril and ECG were monitored and noted at the time of induction, postinduction, during the creation of pneumoperitoneum, then every 15 min throughout the procedure and every 30 min postoperatively. Inflation pressure of CO2 during pneumoperitoneum was kept below 15 mmHg in all cases. Hypotension was defined as >20% decrease in systolic BP and was treated with iv fluids and ephedrine 6 mg in incremental doses. Bradycardia (heart rate <60/min) was treated with iv atropine. Intraoperative complaints of shoulder tip pain were noted and the severity was gauged using the 10 cm visual analogue scale where 0 meant no pain and 10 meant worst pain experience. Adverse effects such as postoperative nausea and vomiting were also recorded. No other sedative or analgesic was given intraoperatively unless demanded by the patient. When demanded, sedation was given in the form of injection midazolam 0.03 mg/kg iv and analgesia in the form of injection nalbuphine 10 mg iv and injection ketamine 20 mg added in case of shoulder discomfort. Postoperative rescue was given in the form of diclofenac sodium 75 mg iv infusion. The time and frequency of rescue analgesic were also recorded. The duration of spinal anesthesia was considered as that from the onset of the sensory block to the administration of the rescue analgesic.

Data were analyzed using statistical tests, Chi-square and Student's t-test; P < 0.05 was considered as statistically significant.

RESULTS

A total of 60 patients undergoing elective laparoscopic surgeries under spinal anesthesia were enrolled in our study and divided into two groups, namely group A receiving 0.5% hyperbaric bupivacaine 3.0 ml with NS to make 3.50 ml and group B receiving 0.5% hyperbaric bupivacaine 3.0 ml along with injection dextmedetomidine 5 µg to make a volume of 3.50 ml. Both groups were comparable with respect to age, sex and weight [Table 1].

Table 1

Demographic data of patients

Figure 1 shows comparison of systolic BP between the two groups. The systolic BP decreased after induction in both the groups but it fall was more in group A as compared to group B. In group B, 15 patients and in group A, 20 patients required ephedrine treatment. After pneumoperitoneum, there was a slight increase in the systolic BP in both the groups being more in group A than in group B. Thereafter, the systolic BP remained stable in group B, but in group A, it showed a slight increase. The difference in the postinduction systolic BP between the two groups was statistically significant with a P = 0.0001.

Figure 1

Comparison of systolic blood pressure between the two groups

The pulse rate in the group A increased after pneumoperitoneum but it remained low in group B though in no case it decreased below 60/min [Figure 2].

Figure 2

Changes in the pulse rate in the two groups

EtCO2 increased in response to pneumoperitoneum in both the groups and changes were comparable. Saturation and ECG were normal in both the groups throughout the procedure and postoperatively. SpO2 remained >95% in all the patients throughout the intraoperative period.

Spinal anesthesia was adequate for surgeries with no operative difficulties in all the patients. The quality of spinal anesthesia is compared in Figure 3 from where it can be discerned that dextmedetomidine has no effect on the onset of spinal anesthesia. The sensory and motor level onsets were similar in either group. Two-segment regression occurred early in group A than group B and the difference was statistically significant (P = 0.0001). In addition, it was noted that dextmedetomidine significantly prolong the duration of spinal anesthesia and motor block [Table 2] thereby extending the analgesia as indicated by delayed demand for rescue analgesia in the postoperative period [Figure 4].

Figure 3

Incidence of shoulder tip pain and sedation and analgesia requirement

Table 2

Onset and regression of Bromage Score

Figure 4

Onset and duration of spinal anesthesia and time of rescue analgesia. (SA: Sensory anesthesia)

In our study, we found that in group B, only three patients complained of shoulder tip pain and had to be administered sedation and analgesia. However, 27 patients in group A had shoulder tip pain and demanded sedation and analgesia. The difference in complaints of shoulder tip pain as well as sedation-analgesia requirements in both groups were found to be statistically highly significant (P < 0.0001) [Figure 3].

DISCUSSION

The problem faced by anesthesiologists in laparoscopic surgeries under spinal anesthesia is shoulder tip pain.[45678] The exact etiology of this shoulder tip pain is not known, the most popular theory is that of diaphragmatic irritation and the shoulder tip pain being actually a referred pain and hence difficult to treat. We studied the efficacy of intrathecal dextmedetomidine to abolish the shoulder tip pain.

Dextmedetomidine is a highly specific and selective α2-adrenergic agonist with sedative, anxiolytic, and analgesic effects. It is a selective α2 agonist and acts by inhibiting norepinephrine release from presynaptic terminals. It is 16 times more specific than clonidine for α2 receptors. It possesses sedative, analgesic, anxiolytic, hemodynamics stabilizing properties with preservation of ventilator drive. In addition, it prolongs sensory and motor blockade of regional anesthesia and provides sedative effects. This effect is responsible for the sympatholytic effect produced by dextmedetomidine.[24] It acts by central nervous system stimulation of parasympathetic outflow and inhibition of sympathetic outflow from the locus ceruleus in the brainstem leading to sedation and anxiolysis. Primary analgesic effects and potentiation of opioid-induced analgesia result from the activation of α2-adrenergic receptors in the dorsal horn of the spinal cord and the inhibition of substance P release. Hypotension and bradycardia have been reported in adults especially in the presence of comorbid cardiac disease or when administered with other medications that possess negative chronotropic effects and during vagotonic procedures (laryngoscopy) or following large or rapid bolus doses. It causes anxiolysis and sedation through activation of α2-adrenergic in the locus cerulus. It has significant analgesic effect and it reduces opioid requirements by 30–50%. Analgesia that is produced by dextmedetomidine is not only because of sympatholysis at peripheral level, but also due to decrease catecholamine release in brain. All these effects may be responsible for decreasing the shoulder tip pain in patients undergoing laparoscopy under spinal anesthesia with intrathecal dextmedetomidine. Intrathecal dextmedetomidine has been shown to prolong the action of local anesthetics.[171819202122] It has also been seen to provide better postoperative analgesia after intrathecal use.[171819202122] In our study, we found that intrathecal dextmedetomidine of 5 µg does not result in worrisome hypotension. This can be attributed to the increased peripheral vascular resistance after creation of pneumoperitoneum that counteracts the fall in BP. However, bradycardia does occur with this dose, but seldom requires treatment. There are no episodes of apnea, pruritus or postoperative nausea and vomiting as may be seen with opioids when they are used as intrathecal adjuvants with a local anesthetic. The combined property of sedation and analgesia of dextmedetomidine keeps patients pain free and comfortable. At the same time, this obviates unnecessary iv interventions, thus serving the purpose of spinal anesthesia. Spinal anesthesia for laparoscopic surgery provides good muscle relaxation and optimum operative field and also facilitates excellent postoperative analgesia. Dextmedetomidine may be beneficial in obese patients who are at risk of respiratory depression because it attenuates postoperative pain and, therefore, decreases the requirement for opioids. Obese patients have increased gastroesophageal reflux that may be aggravated by increased intra-abdominal pressure. Obese patients were excluded from our study because of concern regarding the aspiration of gastric contents. With adjuvants like intrathecal dextmedetomidine, stable hemodynamics along with good sedation and analgesia is provided abolishing shoulder tip pain, making the procedure more economical and comfortable to the patient. None of the patients needed conversion to general anesthesia. In our study, we found that local anesthetics in combination with dextmedetomidine not only have synergistic effect but also decrease shoulder tip pain and provide good sedation alleviating the need of iv analgesics and sedation. Avoidance of extreme degree of head down tilt, low pressure pneumoperitoneum (5–7 mmHg) and use of N2O insufflation gas instead of CO2 might be helpful to decrease supplemental analgesics and sedatives. Limitations of our study are that we didn't study the effect of different doses of dexmedetomidine and therefore could not comment upon the optimal dose of the drug. Secondly, we have excluded obese patients for the reasons already mentioned above.

CONCLUSION

We recommend the use of dextmedetomidine along with bupivacaine in spinal anesthesia for laparoscopic surgeries. Careful evaluation of the method is needed in patients with compromised cardiorespiratory reserve. Spinal anesthesia with the addition of dextmedetomidine may be feasible for laparoscopic cholecystectomy, but additional analgesia, sedation, careful attention to potential development of bradycardia are needed for a successful anesthetic outcome.