Tonsillectomy pain control with IV dexamethasone, infiltrated dexamethasone and infiltrated bupivacaine; a randomised, double-blind, placebo controlled, prospective clinical trial.
Objective: To compare effects of local and systemic administrations of dexamethasone and local bupivacaine on postoperative pain in patients who have had tonsillectomy.
Methods: This randomised, double-blinded, placebo-controlled and prospective clinical trial was conducted at Adana Numune Training and Research Hospital, Turkey, between April and July 2016, and comprised patients who were undergoing tonsillectomy operation due to recurrent tonsillitis, chronic tonsillitis or tonsillar hypertrophy indication. Patients were randomly assigned to 4 equal groups. Group 1 was administered 0.5 mg/kg intravenous dexamethasone. Group 2 was given 0,5mg/kg dexamethasone diluted with 10 mL saline which was infiltrated into the peritonsillar regions. Group 3 received 2.5 mL of 0.5% bupivacaine infiltration. Group 4 was the control group and received peritonsillar saline infiltration. Pain was evaluated with visual analogue scale and the data obtained was analysed with SPSS 20.
Results: Of the 60 patients, each group had 15(25%). Visual analogue scale values at the 15th minute was significantly lower in Group 1 compared to the other groups (p<0.05). Values of Group 4 were higher from the 1st hour through to the 24th hour compared to the other groups (p0.05). Values of Group 4 at the 6th and 12th hours were significantly higher compared to Groups 1 and 2 (p0.05) (Table-1). Also, there was no significant association between gender and the groups (p>0.05) (Table-2). Pain evaluation of patients was carried out with VAS (Table-3) (Figure), and values at the 15th minute were significantly lower in Group 1 compared to the other groups (p<0.05). VAS values at the 1st hour and 1st day were significantly higher in Group 4 compared to the other groups (p0.05).
Values of Group 4 at the 6th and 12th hours were significantly higher compared to Groups 1 and 2 (p0.05). No statistically significant differences were found among the groups in terms of the VAS values at the 1st week (p>0.05). No statistically significant difference was observed between the groups in terms of bleeding amount (p>0.05). Operational time was significantly shorter in Group 1 compared to Group 2 (p0.05) (Table-4).
No statistically significant association was observed between the groups in terms of vomiting (p>0.05). There was a significant association between the groups and the need for analgesics (p<0.05) (Table-5).
Tonsillectomy is one of the most frequently performed surgeries in otorhinolaryngology clinics. Pain reduction is crucial in order to provide patients comfort and enable them to go through this course more comfortably. Besides disruption of the quality of life, pain may also cause insufficient oral intake and dehydration, prolonging the duration of hospitalisation. From the past until today, numerous different approaches have been attempted for this purpose. Many techniques and drugs have been used such as peritonsillar local anaesthetics, nerve blockades, dexamethasone or different surgical approaches in order to reduce pain, but there is still no consensus about this issue. Recent electrophysiological studies have demonstrated that, a stimulus which forms due to tissue damage stimulates afferent C fibres which in turn stimulates the dorsal horn neurons, resulting in pain.16,17 Different surgical methods are likely to cause pain of varying severity.
In a study comparing electrocautery and blunt dissection regarding pain, the use of electrocautery has been reported to create significantly greater pain.18 Similarly, in another study comparing thermal welding, electrocautery and blunt dissection, electrocautery was found to produce more severe pain.19 In our study, we performed our operations by the same surgeon using blunt dissection in order to avoid influences on postoperative pain. Haemostasis was obtained by compression and catgut sutures, if required. We did not use electrocautery.
A meta-analysis said pain is the most important cause of morbidity following tonsillectomy and that peritonsillar local anaesthetic infiltration is successful regarding this issue.20 Among the most commonly used local anaesthetics are bupivacaine and its derivatives. In a study with adult patients undergoing tonsillectomy and uvulopalatopharyngoplasty (UPPP), effect of bupivacaine has been investigated and it was recommended to be used for pain reduction in intraoral surgeries.21 A study showed that levobupivacaine was more effective on postoperative pain and intraoperative bleeding compared to saline.22 Bupivacaine is a local anaesthetic belonging to amino amide group which inhibits access of sodium to the nerve cells, preventing depolarisation. Bupivacaine has become popular in postoperative analgesia due to its higher effect of sensory blocking rather than motor blocking.
However, because of its cardiotoxic and neurotoxic impacts, levobupivacaine which is S-enantiomer of bupivacaine has been included more commonly in recent studies. Levobupivacaine can be preferred as an alternative to bupivacaine in patients with cardiac disease.21 It was reported in a study comparing bupivacaine and levobupivacaine that, both agents similarly reduced pain, but the effect duration of bupivacaine was slightly longer.23 In our study, patients with cardiac disease were excluded and bupivacaine was used for its longer duration of effect. In another study performed on 60 paediatric patients undergoing tonsillectomy, bupivacaine was stated to be an effective and reliable local anaesthetic, equivalent to lidocaine.24 In our study, we did not encounter any complications in our patients due to bupivacaine and found that pain reducing effect of bupivacaine was statistically significantly higher at 15th minutes, 1st hour and 1st day compared to the controls.
VAS is a reliable method used for evaluation of pain for years. It is quite important to inform patients in order to obtain true outcomes. It has been reported in the literature that a reasonable level of pain persists in 7 days after tonsillectomy; however pain is quite severe within the first 3 days and shows a progressive alleviation after the 4th day.25 Therefore, early postoperative follow-up of patients is crucial for their comfort.
Dexamethasone is a synthetic glucocorticosteroid more potent than endogenous cortisol by 25 folds with anti-inflammatory effects and has a longer half-life of 36-72 hours.26 In an earlier study with 41 paediatric patients, the author observed that single dose of IV dexamethasone was very effective in prevention of postoperative vomiting, but it was equivalent with placebo in terms of postoperative pain and the need for analgesics.27 Similar to that study, we found the least incidences of vomiting in Group 4. However, our results related to pain are not consistent with those of the mentioned study.
In another study, researchers administered single dose of IV 10 mg dexamethasone, evaluated pain every day from the 1st day until the 1st week using VAS and observed that pain was significantly low at the day of operation and at the postoperative days 4, 5, 6 and 7.28 Action of single dose IV systemic dexamethasone begins in a short time because of its wide distribution, but the effect on pain may be decreased due to its lower concentration in the wound site. In another study, considering higher concentrations in the wound site researchers recommended the use of submucosal dexamethasone injection.29
One of the studies compared effects of the local and IV dexamethasone on pain and found that local administration of dexamethasone was more effective within the first 16 postoperative hours.30 In another study with 120 children, one group was given a combination of levobupivacaine and dexamethasone infiltration and another group was administered IV dexamethasone and levobupivacaine infiltration. They found lower VAS scores at all hours and significantly lower scores at the 2nd, 6th, 12th and 24th hour in dexamethasone infiltration group. Although VAS scores were found to be lower in the early postoperative period at the 15th and 30th minutes and in the late postoperative period after postoperative 4th day, the differences were not statistically significant.31
On the other hand, in a study with 62 patients undergoing tonsillectomy, effect of infiltrated dexamethasone on pain was not significant compared to saline.32 In our study, VAS values at the 15th minute were significantly lower in Group 4, although no significant differences were observed at the other times. In the present study, we compared local and IV dexamethasone additionally with bupivacaine which has been proved in a number of studies to be an effective local anaesthetic for post tonsillectomy pain. One study compared effects of dexamethasone and levobupivacaine infiltrations on post tonsillectomy pain and reported that local dexamethasone infiltration is more effective in reduction of pain.33
Although in our study, bupivacaine was found to be more effective in reduction of pain compared with the control group, VAS was found to be higher in this group compared to both groups of dexamethasone. This study is the first to compare these three groups together. We found significantly lower VAS scores evaluating pain in all three groups compared to the control group. While IV dexamethasone was found to be effective, this effect reached to statistical significant at the 15th minute. The least need for analgesics was also observed in this group. The limitation of our study is that our number of patients may be more but adult tonsillectomy is fewer than children tonsillectomy in our clinic. Similarly larger series are needed to confirm this result. Secondly, though the VAS is a simple, valid and reliable method used for many years, a wide degree of inter-patient variability exists.
IV dexamethasone, infiltrated dexamethasone and infiltrated bupivacaine were all effective on postoperative pain compared to the control group. However, single dose IV dexamethasone was found to be more effective, especially in the reduction of pain in the early period. It can be preferred in patients undergoing tonsillectomy because it is safe, inexpensive and easily applicable. Nevertheless, similar larger series are needed to confirm this result.
Disclaimer: Due to non-existence of RCT registration authority in Turkey. Hence RCT Trial Number has not been allotted. The approval to conduct the study has been taken from local IRB.
Conflict of Interest: None.
Source of Funding: None.
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|Publication:||Journal of Pakistan Medical Association|
|Date:||Jul 31, 2018|
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