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 Table of Contents  
ORIGINAL ARTICLE
Year : 2018  |  Volume : 11  |  Issue : 1  |  Page : 60-64

A randomized controlled trial to evaluate the efficacy of Karpura Ghrita as a topical analgesic with lignocaine jelly 2% in posthemorrhoidectomy pain


Department of Sangyaharana, KLEU's Shri B M Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka, India

Date of Web Publication17-Jan-2018

Correspondence Address:
Amruta Ashok Wali
KLEU's Shri B M Kankanwadi Ayurveda Mahavidyalaya, Belagavi, Karnataka
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/kleuhsj.kleuhsj_127_17

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  Abstract 


INTRODUCTION: Effective postoperative pain control is an essential component of the care of the surgical patient. Uncontrolled pain may cause restlessness and thereby delay in wound healing. Haemorrhoids are certainly one of the commonest ailments that afflict mankind. NSAID's have been traditionally been used to relieve pain after minor or major surgery. There are many modes of treating the local pain like by lignocaine Jelly2%, glycerine packing, diclofenac suppository which reduces the pain but they may bring delayed wound healing. The use of Karpura-Ghrita is mentioned in classics after shastrakriya for Pain (Vedana) management. Hence, this study is planned to evaluate the effect of Karpura-Ghritaan topical analgesic in post haemorrhoidectomy pain.
AIM: To evaluate the analgesic effect of KarpuraGhrita
OBJECTIVES: To evaluate the analgesic effect of KarpuraGhrita with Lignocaine jelly 2% gauze packing in post-operative Haemorrhoidectomy.
MATERIALS AND METHODS: 30 patients who undergone haemorrhoidectomy under local anaesthesia, fulfilling the inclusion criteria were randomly selected from I.P.D of Shalyatantra of KLEU's Shri BMK Ayurveda Mahavidyalaya, Belgavi and divided into Group 1 and Group 2 comprising of 15 patients each. Group 1 (study group) was treated with KarpuraGhrita gauze packing and Group 2 (control group) was treated with lignocaine jelly 2% gauze packing after Haemorrhoidectomy. Patients were assessed for requirement of 1st dose of analgesic and Pain assessed by Verbal Descriptive Scale.
OBSERVATIONS AND RESULTS: Pain score by Kruskalwallis multiple comparison test showed significant result in both the groups. Pain score between the two groups was evaluated by Mann-Whitney U test which showed non-significant result.
CONCLUSION:

  1. KarpuraGhrita has shown analgesic effect.
  2. Both the drugs have shown significant effect in post haemorrhoidectomy pain management.

Keywords: Hemorrhoidectomy, Karpura Ghrita, lignocaine Jelly 2%, local anesthesia, pain management


How to cite this article:
Shukla VR, Wali AA, Dongargaon TN. A randomized controlled trial to evaluate the efficacy of Karpura Ghrita as a topical analgesic with lignocaine jelly 2% in posthemorrhoidectomy pain. Indian J Health Sci Biomed Res 2018;11:60-4

How to cite this URL:
Shukla VR, Wali AA, Dongargaon TN. A randomized controlled trial to evaluate the efficacy of Karpura Ghrita as a topical analgesic with lignocaine jelly 2% in posthemorrhoidectomy pain. Indian J Health Sci Biomed Res [serial online] 2018 [cited 2019 Sep 16];11:60-4. Available from: http://www.ijournalhs.org/text.asp?2018/11/1/60/223418




  Introduction Top


Effective postoperative pain control is an essential component of the care of the surgical patient. Inadequate pain control, apart from being inhumane, may result in increased morbidity or mortality. Good analgesia can reduce this deleterious effect. The advantages of effective postoperative pain management include patient comfort and therefore satisfaction, earlier mobilization, fewer pulmonary and cardiac complications, a reduced risk of deep vein thrombosis, faster recovery with less likelihood of the development of neuropathic pain, and reduced cost of care.[1]Hemorrhoids are certainly one of the most common ailments that afflict humankind. Hemorrhoids are dilated veins within the anal canal in the subepithelial region formed by radicles of the superior, middle, and inferior rectal veins.[2] The incidence of piles apparently increases with age, and it seems likely that at least 50% of people over the age of 50 have some degree of hemorrhoid formation. Men seem to be afflicted roughly twice as frequently as women. Hemorrhoids with grade 3 and 4, require an operative hemorrhoidectomy to eliminate hemmorhoidal symptoms.[3]

In modern medicine, so many drugs are explained under analgesics. Nonsteroidal anti-inflammatory drugs (NSAID'S) are one of them. NSAID's have been conventionally been used to relieve pain after minor or major surgery.[4] There are many modes of treating the local pain like by lignocaine Jelly 2%, glycerin packing, diclofenac suppository which reduces the pain but they may bring delayed wound healing.[5]

The use of Karpura-Ghrita is mentioned in classics after shastrakriya for Pain (Vedana) management. According to Chakradutta, the paste prepared of ghrita mixed with the karpura (camphor) in equal quantity, is vranavedanashamak in Sadhoyavarna.[6]

Hence, this study is planned to evaluate the effect of Karpura-Ghritaan topical analgesic in posthemorrhoidectomy pain.


  Methodology Top


Collection and preparation of drug

Drugs required for the preparation of Karpura Ghrita were collected from Belgavi. Identification and authentication of the collected drug have been done with the help of CRF, K. L. E. s Ayurveda College, Belgavi.

The ingredients of the Karpura Ghrita are:

  • Karpura
  • Ghrita.


Preparation of Karpura Ghrita.[6]

  • Two hundred gram of Karpura was taken in khalwa yantra, made in to powder form
  • Karpura Churna of 30 samples of each 5 g vial were prepared
  • Goughrita of 30 samples of each 5 g vial were prepared
  • Karpura Ghrita was prepared by mixing equal quantity of luke warm 5 gms of Ghrita and 5 g of Karpura in a sterile bowl
  • Karpura Ghrita was applied over 4 × 4 gauze roll, and anal packing was done.


Selection of the patients

In this randomized control clinical trial, 30 patients of either sex of American Society of Anesthesiologists Grade I or II [7] were selected from indoor patient department of Shalya ward who undergone hemorrhoidectomy operation under local anesthesia.

Inclusion criteria

  • Consented individuals
  • Either Sex, Age group between 20 and 60 years
  • Hemorrhoidectomy under local anesthesia.


Exclusion criteria

  • Subjects suffering from severe systemic diseases such as diabetes, hypertension, bronchial asthma, cardiac diseases, renal failure, etc.
  • Chronic alcoholic and chronic smoker
  • Subjects on anti-depressant and anti-psychotic drugs
  • Subjects receiving regular medication containing any analgesic drugs.


Grouping of patients

A total of 30 patients selected for the present clinical study were randomly divided into two equal and identical groups consisting of 15 patients in each group using computer generated block randomization.

Group A (Study Group):

  • In this group, Karpura Ghrita gauze was applied immediately after Hemorrhoidectomy.


Group B (Control Group):

  • In this group lignocaine jelly, 2% was applied immediately after hemorrhoidectomy.


Methodology

All the patients were assessed thoroughly, and consent was taken about the proposed research work. Their age (years), weight (kg), and vital status, namely, pulse rate, blood pressure, respiratory rate, and oxygen saturation were recorded. General condition, physiological, and psychological conditions were also recorded. After complete satisfaction, the grouping was done as discussed previously.

A total of thirty patients having hemorrhoidectomy were randomly allocated before surgery to have postoperative packing of the anal canal with either Karpura Ghrita gauze roll or with lignocaine jelly 2% gauze roll with 15 patients in each group.

Assessment and follow up

Postoperatively, pain was assessed by verbal descriptive scale (from 0 to 10) after anal gauze packing, at 0 h, half an hour, 1 h, 1½ h, 2nd h, 3rd h, 4th h, 5th h, and after 6th h. After that pain was managed as per routine parental drug treatment [Figure 1].
Figure 1: Verbal descriptive scale

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Rescue Analgesic: As per ethical sight if the pain was not controlled by a control or study drug rescue analgesic in the form of injection diclofenac sodium 75 mg I/M given and time of administration was recorded.


  Observations and Results Top


Pain scores in Karpura Ghrita group

Pain score by Kruskal–Wallis multiple comparison test showed significant result within the group [Table 1].
Table 1: Pain score in KarpurGrhita (VDS)

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From baseline till 4th h pain score showed nonsignificant result means that Karupra Ghrita has analgesic action till 4th h from baseline. When compared baseline to 5th h pain score showed significant result with mean 1.2 ± 1.656 and P = 0.0114. This means that the patients started complaining of pain at 5th h after application of Karupra Ghrita [Graph 1] and [Table 2].
Table 2: Pain score in KrapurGrhita

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Pain scores in lignocaine jelly 2%

Pain score by Kruskal–Wallis multiple comparison test showed significant result within the group [Table 3].
Table 3: Pain score in Lignocaine jelly 2% (VDS)

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From baseline till 4th h pain score showed nonsignificant result means that Ligocaine jelly has analgesic action till 3rd h from baseline. When compared baseline to 4th h pain score showed the significant result with mean 1.6 ± 1.549 and P < 0.0001. This means that the patients started complaining of pain at 4th h after application of Lignocaine jelly 2% [Graph 2] and [Table 4].
Table 4: Pain score in Lignicaine Jelly 2%

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Pain scores between two groups

Pain score between the two groups was evaluated using Mann–Whitney U-test which showed the nonsignificant result [Table 5].
Table 5: Pain score between the two groups was evaluated by Mann-Whitney U test

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Requirement time of 1st dose of analgesic

The mean of the 1st analgesic dose requirement time (in hours) of all patients in Group 1 and Group 2 were recorded and statistically compared. Statistical comparison on requirement of the first dose analgesic time between the groups is nonsignificant [Graph 3] and [Table 6].
Table 6: Statistical comparison on requirement of the first dose analgesic time between the groups

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Effect on verbal descriptor scale

This table shows a statistical comparison of difference in mean verbal descriptor scale (VDS) Scale between the groups by applying Pain scores between two study groups (Karpura Ghrita and Lignocane jelly 2%). In this study, Mean VDS score of Karpura Ghrita group is 2.667 ± 0.3187, whereas in lignocaine jelly 2% group is 2.533 ± 0.4125. It shows statistically nonsignificant P value so Karpura Ghrita having similar analgesics property as compared to lignocaine 2% jelly [Table 7].
Table 7: Statistical comparison of difference in mean VDS Scale between the groups by applying Pain scores between two study groups (Karpuraghrita and Lignocane jelly 2%)

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  Discussion Top


Pain is an important and most commonly encountered undesirable effect in any surgical procedure. Postoperative pain is an anticipated and often feared consequence in patients undergoing surgery. It is an impending warning signal about the existence of a problem or threat which needs to be addressed and solved to prevent further damage.[8]

The effective treatment of postoperative pain will result in real benefits to the patients and surgical units. Uncontrolled pain may cause restlessness and thereby delaying in wound healing.

The use of Karpura-Ghrita is mentioned in classics after shastrakriya for Pain (Vedana) management. According to Chakradutta, the paste prepared of Ghrita mixed with the karpura (camphor) in equal quantity, is vranavedanashamak in Sadhoyavarna.

Analgesic action of the drug

Lignocaine jelly 2% - lignocaine stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anaesthetic action.[8]

Karpura Ghrita - The camphor-induced desensitization of TRPV1 and block of TRPA1 may underlie the analgesic effects of camphor. Camphor is known to klnpotentiate heat sensation which can be explained by activation of heat sensitive transient receptor potential channel. TRPV1, TRPV3.[9]

Probable mode of action (Karpura Ghrita)

In shatraabhightajanyavrana there is prakopa of vatadosha and raktadhatudushti. Madhura rasa helps in alleviates vatadosha and madhura, tikta rasa, sheetaveerya of Karpura helps in rectifying raktadushti.[10]

Ghrita alleviates vata by snigdhaguna. It has action on raktadhatu due to ashryaashryaibhava of rakta and pitta. Therefore, rectifying raktadushti. Ghrita is a media in which karpura is dissolved. Ghrita is well known for its property of samskrasyaanuvartana, which thereby potentiate the action of karpura.

Requirement time of the first dose of analgesic drugs

After the effect of anesthesia recedes the 1st dose of analgesic was given at the onset of pain. The observation recorded suggests that the first dose of analgesic in the study group is 4.667 ± 0.252 and in control group is 4.467 ± 0.2364 which is statistically insignificant. It means that the required time of 1st analgesic dose is same in both the groups which suggest that the both drugs are having equal analgesic action. Lignocaine acts by blocking the nerve fibers and Karpura Ghrita act by its anti-inflammatory action.

Effect on verbal descriptor scale

The effect on VDS in the study group is 2.667 ± 0.3187 and in control group is 2.533 ± 0.4125 which is statistically insignificant. It means that pain threshold capacity of Karpura Ghrita and Lignocaine Jelly 2% are same.


  Conclusion Top


  • Karpura Ghrita have shown analgesic effect
  • Both the drugs have shown a significant effect in posthemorrhoidectomy pain management.


Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Michael AE. Ramsay – Proc Acute postoperative pain management. Bayl Univ Med Cent 2000;13:244-7.  Back to cited text no. 1
    
2.
Praveen Kumar M, Sijoria KK. Diagnosis and Management of Ano-Rectal Diseases. Ch. 4. Delhi: Chaukhanbha Sanskrit Pratishtana; 2009. p. 101.  Back to cited text no. 2
    
3.
Mounsey AL, Halladay J, Sadiq TS. Hemorrhoids. Am Fam Physician 2011;84:204-10.  Back to cited text no. 3
[PUBMED]    
4.
Murphy DR. NSAID in post-operative pain managements. BMJ J 1993;306:1493.  Back to cited text no. 4
    
5.
Xylocaine Jelly – Clinical Pharmacology. Available from: http://www.drugs.com/sfx/xylocaine-jelly-side-effects.html. [Last accessed on 2017 Aug 02].  Back to cited text no. 5
    
6.
Tripathi I. Chakradatta Commentary. Ch. 44. Verse No. 53. Chaukhamba Sanskrit Bhavan, Varanasi; 2011. p. 262.  Back to cited text no. 6
    
7.
Miller RD. Millers Anesthesia. 7th ed. USA: Heather Krehling; 2010. p. 1002.  Back to cited text no. 7
    
8.
Nigam V. A Randomized, Comparitve Clinical Study Of Yashtimadhu Ghrita With Lignocaine Jelly 2% Gauze Packing For Post Haemorrhoidectomy Pain Management, 2014.  Back to cited text no. 8
    
9.
Hamidpour R, Hamidpour M. Sohe Milain Haa Simhaploaruir, Camphor (Cinnamomum camphora), with the history of treating seveartarladdiisteioanseasl remedy review article. IJCRI 2013;4:86-9.  Back to cited text no. 9
    
10.
Shastri JL. Dravya Guna Vigyana. 2nd ed., Vol. 2. Varanasi: Chaukhambha Orientalia; 2005. p. 471.  Back to cited text no. 10
    


    Figures

  [Figure 1]
 
 
    Tables

  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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