Objective: Arthroscopic knee surgery is frequently performed as a day-care procedure; however, inadequate postoperative analgesia may delay mobilization, rehabilitation, and discharge. Intra-articular administration of local anaesthetics with adjuvants is an effective strategy for improving postoperative pain control. This study aimed to compare the analgesic efficacy and hemodynamic stability of intra-articular dexmedetomidine and tramadol when used as adjuvants to ropivacaine in patients undergoing arthroscopic knee surgery under spinal anaesthesia during the early postoperative period. Methodology: This prospective, randomized, double-blind, controlled study included 60 adult patients aged 18–60 years with ASA physical status I or II scheduled for elective arthroscopic knee surgery. All patients received low-dose spinal anaesthesia. Participants were randomly allocated into three groups: Group I received intra-articular ropivacaine with dexmedetomidine, Group II received ropivacaine with tramadol, and Group III received ropivacaine with normal saline. Postoperative pain was assessed using the visual analogue scale (VAS) at 0, 2, 4, 6, 12, and 24 hours. Time to first rescue analgesia, total rescue analgesic requirement, haemodynamic parameters, sedation scores, and adverse effects were recorded and analysed statistically. Results: Demographic characteristics and baseline haemodynamic variables were comparable among the three groups. The time to first rescue analgesia was significantly prolonged in the dexmedetomidine group compared with the tramadol and control groups (p < 0.001). VAS scores were significantly lower in patients receiving dexmedetomidine during the early postoperative period. Total rescue analgesic consumption was also significantly reduced in this group. Haemodynamic parameters remained stable across all groups, and no clinically significant adverse effects were observed. Conclusion: Intra-articular dexmedetomidine, when used as an adjuvant to ropivacaine, provides superior and prolonged postoperative analgesia with reduced rescue analgesic requirements compared to tramadol, without increasing adverse effects. It represents a safe and effective option for postoperative pain management following arthroscopic knee surgery under spinal anaesthesia.
Arthroscopy of the knee joint, including anterior cruciate ligament reconstruction, is a commonly performed outpatient procedure. Effective postoperative pain management is essential to facilitate early mobilization, rehabilitation, and timely discharge. Traditionally, postoperative pain has been managed using oral analgesics, including opioids administered on an as-needed basis. However, this approach often results in inadequate pain control, which may delay discharge, hinder participation in rehabilitation programs, prolong recovery, worsen clinical outcomes, and increase healthcare utilization.
Intra-articular administration of analgesics is a well-established technique for postoperative pain management following arthroscopic knee surgery. Intra-articular instillation of local anaesthetics provides targeted analgesia with minimal systemic effects and has been widely adopted by orthopaedic surgeons. To enhance the duration and quality of analgesia, several adjuvants have been evaluated in combination with intra-articular local anaesthetics, including morphine [1], clonidine [2], fentanyl [3], and tramadol [4,5].
Dexmedetomidine is a highly selective α2-adrenergic agonist with a markedly greater α2:α1 receptor selectivity ratio compared with clonidine. It is widely used for sedation and anxiolysis in intensive care settings and is the S-enantiomer of medetomidine. Unlike opioids and sedative agents such as propofol and benzodiazepines, dexmedetomidine provides sedation and analgesia without causing respiratory depression [6]. Its sedative effect closely resembles natural sleep and is associated with less amnesia [7]. Dexmedetomidine exerts analgesic effects at both spinal and supraspinal levels [8], thereby reducing opioid requirements while maintaining effective pain control.
Intravenously administered dexmedetomidine demonstrates linear pharmacokinetics, with a rapid distribution half-life and a terminal elimination half-life of approximately two hours. It is highly protein bound [9], primarily metabolized in the liver via glucuronidation and cytochrome P450 pathways, and predominantly excreted in the urine.
To date, comparative data evaluating intra-articular dexmedetomidine as an adjuvant to ropivacaine in patients undergoing arthroscopic knee surgery under spinal anaesthesia are limited. Therefore, this prospective, randomized, controlled study was designed to compare the analgesic efficacy and hemodynamic stability of intra-articular dexmedetomidine and tramadol as adjuvants to ropivacaine during the early postoperative period following arthroscopic knee surgery.
After obtaining approval from the Institutional Ethical Committee (Ref. No. 0018/Ethics/R.Cell-16) of King George’s Medical University (KGMU), Lucknow, written informed consent was obtained from all participants. This prospective, randomized, double-blind, controlled study was conducted in 60 patients of either sex, aged 18–60 years, with ASA physical status I or II, scheduled for elective arthroscopic knee surgery. Patients with ±20% of ideal body weight and height were included. Patients were excluded if they had severe systemic disease, known allergy to study drugs, long-term analgesic use, intake of analgesics or non-steroidal anti-inflammatory drugs within 24 hours before surgery, seizure disorder, traumatic knee injury, or refusal to participate. All patients were preoperatively familiarized with a 10-cm visual analogue scale (VAS) [Table 1], where 0 represented no pain and 10 the worst imaginable pain. Sedation and anxiety were assessed using the Ramsay Sedation Score [Table 2]. Standard monitoring included electrocardiography, non-invasive blood pressure, and pulse oximetry. Using a computer-generated randomization sequence, patients were allocated into three groups (n = 20 each). Group I received intra-articular ropivacaine 0.2% (19 mL) with dexmedetomidine (1 µg/kg); Group II received intra-articular ropivacaine 0.2% (19 mL) with tramadol (1 mL); and Group III received intra-articular ropivacaine 0.2% (19 mL) with normal saline (1 mL). The study drugs were prepared by an independent anaesthesiologist and were blinded to the surgeon, anaesthesiologist, and patient. All patients underwent standard pre-anaesthetic evaluation, fasted for 8 hours, and received oral ranitidine 150 mg and alprazolam 0.25 mg the night before surgery. Low-dose spinal anaesthesia was administered with 1.5 mL of 0.5% hyperbaric bupivacaine at the L3–L4 interspace using a 25-G Quincke spinal needle under aseptic conditions. The study drug was injected intra-articular through the arthroscopic port at the end of surgery, with the tourniquet maintained for 10 minutes to prevent drug leakage. Postoperative pain was assessed using VAS at 0, 2, 4, 6, 12, and 24 hours. Sedation was evaluated using the Ramsay Sedation Score. Rescue analgesia was administered when VAS ≥4, using intramuscular diclofenac sodium 75 mg, followed by tramadol 100 mg if pain persisted. Time to first rescue analgesia and total analgesic consumption during the first 24 hours were recorded. Adverse effects, including bradycardia, hypotension, nausea, vomiting, excessive sedation, and respiratory depression, were monitored and managed accordingly. Statistical Analysis Sample size estimation was based on postoperative pain scores as the primary outcome variable. Based on data from a pilot study and assuming a standard deviation of 1 cm, a minimum of 17 patients per group was required to achieve 80% power to detect a difference of 1 cm on the visual analogue scale (VAS) at a two-sided significance level of 5%. To account for possible dropouts, 20 patients were enrolled in each group. Statistical analysis was performed using the Statistical Package for the Social Sciences (SPSS), version 15.0. Continuous variables were expressed as mean ± standard deviation (SD), while categorical variables were presented as number and percentage. Intergroup and intragroup comparisons of continuous parametric data, including heart rate and systolic and diastolic blood pressure, were analysed using analysis of variance (ANOVA). The Chi-square test was used to compare categorical variables, including demographic characteristics and outcome measures. VAS scores, which were not normally distributed, were analysed using the Kruskal–Wallis H test to assess differences among the three study groups. A p value of less than 0.05 was considered statistically significant.
This study was conducted in the Department of Anaesthesiology, King George’s Medical University, Lucknow, and included 60 adult patients who met the inclusion criteria and provided informed consent. Patients were randomly allocated into three equal groups of 20 each: Group I received intra-articular dexmedetomidine, Group II received intra-articular tramadol, and the control group received intra-articular normal saline.
Demographic Characteristics
The overall age of patients ranged from 18 to 56 years. The mean age was higher in the dexmedetomidine group compared with the tramadol and control groups; however, this difference was not statistically significant. The majority of patients in all groups were between 21 and 40 years of age. Male patients predominated across all groups, and the gender distribution was comparable, with no statistically significant intergroup difference. [Table 3]
Pain Scores
Baseline VAS scores at rest and on movement were comparable among the three groups. During the postoperative period, significant differences in VAS scores were observed at specific time points. At 4, 6, and 24 hours postoperatively, VAS scores were significantly lower in the dexmedetomidine group compared with the tramadol and control groups. The control group consistently demonstrated higher pain scores at these time points. No statistically significant differences were observed at 0, 2, or 12 hours postoperatively. [Table 4]
Haemodynamic Parameters
Heart rate, systolic blood pressure, and diastolic blood pressure remained within clinically acceptable limits in all groups throughout the study period. Significant intergroup differences in heart rate were observed at 4, 6, and 24 hours postoperatively, with higher values noted predominantly in the tramadol and control groups. Systolic blood pressure differed significantly among groups at 6 and 12 hours, while diastolic blood pressure showed a statistically significant difference only at 24 hours. These variations were transient and did not require therapeutic intervention [ Table 5,6,7].
Rescue Analgesia
The requirement for rescue analgesia was significantly lower in the dexmedetomidine group compared with the tramadol and control groups. Time to first rescue analgesia was longest in patients receiving dexmedetomidine, followed by the tramadol group, and shortest in the control group. This difference was statistically significant. Total analgesic consumption during the first 24 hours was also significantly reduced in the dexmedetomidine group [Table 8].
Sedation and Adverse Effects
Most patients exhibited Ramsay Sedation Scores greater than 2, with no significant intergroup differences. No episodes of bradycardia, hypotension, excessive sedation, or respiratory depression were observed. Nausea and vomiting occurred in one patient in the tramadol group; however, the incidence of adverse effects was comparable among groups and not statistically significant. [Table 9]
Table 1:
Table 2: RAMSAY SEDATION SCORE:
|
Score |
Response |
|
1 |
Patient anxious and agitated or restless, or both |
|
2 |
Patient co-operative, oriented, and tranquil |
|
3 |
Patient responds to commands only |
|
4 |
Brisk response to a light glabellar tap or auditory stimulus |
|
5 |
Sluggish response to a light glabellar tap or auditory stimulus |
|
6 |
No response to the stimuli mentioned in items 4 and 5 |
Table 3: Intergroup Comparison of Demographic Variables
|
|
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance |
||||
|
No. |
% |
No. |
% |
No. |
% |
c² |
p |
|
|
Up to 20 |
4 |
20.00 |
3 |
15.00 |
2 |
10.00 |
10.667 |
0.221 |
|
21-30 |
6 |
30.00 |
3 |
15.00 |
11 |
55.00 |
||
|
31-40 |
6 |
30.00 |
8 |
40.00 |
5 |
25.00 |
||
|
41-50 |
3 |
15.00 |
6 |
30.00 |
2 |
10.00 |
||
|
>50 |
1 |
5.00 |
0 |
0.00 |
0 |
0.00 |
||
|
Mean ± SD |
35.95+10.68 |
28.55+8.17 |
30.65+10.62 |
F=2.971; p=0.059 |
||||
|
Range |
18-50 |
18-48 |
18-56 |
|||||
|
Gender |
||||||||
|
Male |
14 |
70.0 |
13 |
65.0 |
16 |
80.0 |
1.149 |
0.563 |
|
Female |
6 |
30.0 |
7 |
35.0 |
4 |
20.0 |
||
Table 4: Intergroup Comparison of VAS Score at Rest and at Action (Kruskal Wallis test)
|
|
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance |
||||
|
Mean |
SD |
Mean |
SD |
Mean |
SD |
H |
p |
|
|
At rest |
1.95 |
0.76 |
1.55 |
0.76 |
1.55 |
0.89 |
3.324 |
0.190 |
|
At action |
3.35 |
1.04 |
3.05 |
0.89 |
3.25 |
1.07 |
0.811 |
0.667 |
Table 5: Comparison of Heart Rate at different time intervals
|
Time |
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance (ANOVA) |
||||
|
Mean |
SD |
Mean |
SD |
Mean |
SD |
F |
p |
|
|
0 hr |
89.00 |
7.44 |
89.60 |
7.30 |
85.40 |
7.84 |
1.819 |
0.171 |
|
2 hr |
89.90 |
5.67 |
91.20 |
7.63 |
89.80 |
10.13 |
0.189 |
0.828 |
|
4 hr |
91.20 |
7.32 |
93.20 |
9.74 |
100.80 |
10.94 |
5.737 |
0.005 |
|
6 hr |
92.30 |
8.24 |
107.00 |
9.89 |
96.70 |
14.54 |
9.053 |
<0.001 |
|
12 hr |
98.80 |
11.71 |
93.10 |
9.22 |
98.30 |
11.65 |
1.671 |
0.197 |
|
24 hr |
91.30 |
7.09 |
90.70 |
9.72 |
104.10 |
10.45 |
13.539 |
<0.001 |
Table 6: Comparison of Systolic Blood pressure at different time intervals
|
Time |
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance (ANOVA) |
||||
|
Mean |
SD |
Mean |
SD |
Mean |
SD |
F |
p |
|
|
0 hr |
126.60 |
5.20 |
124.90 |
8.45 |
123.20 |
6.24 |
1.263 |
0.290 |
|
2 hr |
127.50 |
4.15 |
127.60 |
5.93 |
127.30 |
3.57 |
0.021 |
0.979 |
|
4 hr |
126.80 |
4.37 |
127.80 |
6.42 |
130.30 |
5.81 |
2.071 |
0.135 |
|
6 hr |
130.00 |
5.98 |
136.20 |
4.98 |
128.60 |
6.93 |
9.036 |
<0.001 |
|
12 hr |
132.70 |
6.69 |
129.30 |
5.89 |
128.10 |
5.29 |
3.181 |
0.049 |
|
24 hr |
129.20 |
4.02 |
127.20 |
5.48 |
128.60 |
7.82 |
0.589 |
0.558 |
Table 7: Comparison of Diastolic Blood pressure at different time intervals
|
Time |
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance (ANOVA) |
||||
|
Mean |
SD |
Mean |
SD |
Mean |
SD |
F |
p |
|
|
0 hr |
75.50 |
4.15 |
76.70 |
4.22 |
74.70 |
4.91 |
1.028 |
0.364 |
|
2 hr |
77.30 |
3.80 |
75.30 |
4.01 |
78.30 |
4.07 |
2.973 |
0.059 |
|
4 hr |
77.40 |
3.73 |
78.20 |
5.06 |
80.80 |
5.63 |
2.658 |
0.079 |
|
6 hr |
79.00 |
6.60 |
83.00 |
6.37 |
79.60 |
6.34 |
2.243 |
0.115 |
|
12 hr |
79.40 |
6.59 |
77.90 |
5.49 |
78.20 |
7.94 |
0.277 |
0.759 |
|
24 hr |
78.00 |
4.10 |
79.30 |
4.60 |
82.10 |
5.33 |
3.966 |
0.024 |
Table 8: Intergroup Comparison of Outcome characteristics
|
|
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance |
||||
|
No. |
% |
No. |
% |
No. |
% |
c² |
p |
|
|
Allergic reaction |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
– |
– |
|
RSS <2 |
0 |
0.00 |
0 |
0.00 |
1 |
5.0 |
2.034 |
0.362 |
|
Requirement of analgesia |
14 |
70.00 |
19 |
95.00 |
20 |
100.00 |
10.027 |
0.007 |
Table 9: Intergroup Comparison of Adverse Effects
|
|
Group I (n=20) |
Group II (n=20) |
Control (n=20) |
Statistical significance |
||||
|
No. |
% |
No. |
% |
No. |
% |
c² |
p |
|
|
Bradycardia |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0.000 |
1.000 |
|
Hypotension |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0.000 |
1.000 |
|
Sedation |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0.000 |
1.000 |
|
Nausea & vomiting |
0 |
0.00 |
1 |
5.0 |
0 |
0.00 |
2.034 |
0.362 |
|
Respiratory depression |
0 |
0.00 |
0 |
0.00 |
0 |
0.00 |
0.000 |
1.000 |
Haemodynamic parameters remained stable throughout the study period, and no clinically significant adverse effects were observed. This supports the safety of intra-articular dexmedetomidine when used in appropriate doses as an adjuvant to local anaesthetics.
This prospective, randomized, controlled study demonstrates that intra-articular dexmedetomidine, when used as an adjuvant to ropivacaine, provides superior early postoperative analgesia compared with tramadol in patients undergoing arthroscopic knee surgery under low-dose spinal anaesthesia. Dexmedetomidine was associated with lower pain scores, prolonged duration of analgesia, reduced rescue analgesic requirements, and stable haemodynamic profiles, without an increase in clinically significant adverse effects. Intra-articular tramadol also improved postoperative analgesia compared with local anaesthetic alone, but its analgesic efficacy was inferior to that of dexmedetomidine, particularly beyond the early postoperative period. Based on these findings, intra-articular dexmedetomidine appears to be a safe and effective adjuvant to ropivacaine for postoperative pain management following arthroscopic knee surgery. Larger studies are warranted to further evaluate its safety profile and to explore the influence of patient-related factors and age-related physiological changes on haemodynamic responses during low-dose spinal anaesthesia. Financial support and sponsorship Nil Conflicts of interest There are no conflicts of interest.