Evaluation of efficacy of transdermal diclofenac sodium patch versus transdermal ketoprofen patch for relief of acute post-operative pain in laproscopic abdominal surgery

 

 

Abstract               Background: Transdermal patch is a painless and very simple method for providing postoperative analgesia. The present study was undertaken in patients undergoing elective laparoscopic surgeries under general anaesthesia with an objective to evaluate the efficiency of transdermal diclofenac patch with transdermal ketoprofen patch. Methods: Sixty adult patients of either sex, without any co-morbidity, admitted for elective laparoscopic abdominal surgeries between ages of 18 to 60 years with ASA grade: I and II, weight ranging between 40 to 80 kg and duration of surgeries up to 90 minutes were included in the study and divided in two groups. GROUP- D included 30 patients who received transdermal patch of diclofenac sodium while GROUP-K included 30 patients who received transdermal patch of ketoprofen. Post-operative vitals and pain scores were monitored. A comparison of variables between two groups was done by using unpaired Student̔ t- test and Chi- square test to find the p- value. Results: In group D mean age (years) was 28.7±9.90 and in group K it was 29.6±11.44. Mean duration of analgesia in Group D was 9.2±0.0821 in hours and in Group K was 11.33±0.0584 in hours. (p <0.01) Overall VAS score of group-K was lower than group-D as observed post-operatively at different intervals. Adverse effects observed post-operatively was not statistically significant between two groups. Conclusion: Ketoprofen transdermal patches are effective and, safe pain relievers with an additional better overall assessment of efficacy, tolerability, acceptance and comfort in comparison to diclofenac patch.

Key words: diclofenac, ketoprofen, transdermal patch, VAS, abdominal surgery

 

INTRODUCTION

The international association for the study of pain has proposed a working definition of acute post-operative pain. “Pain is an unpleasant sensory and emotional experience associated with either actual or potential tissue damage. ” The management of postoperative pain is an essential and integral part of the care given to the patient that assumes an important role in transition from the recovery unit to the home environment. All method of postoperative analgesia must meet three basic criteria. It must be 1) effective, 2) safe and 3) predictable. The commonest hospital practice had been to prescribe fixed parenteral dose of a non-steroidal anti-inflammatory drug or an opioid, to be given at fixed time intervals, with the administration of the same being delegated to a nurse. This method of pain relief had a lot of short comings. Besides the discomfort of repeated injections, it may produce undesirable side effects like nausea and vomiting. As each type of surgical procedure has its own unique postoperative pain characteristics and clinical consequences. The choice of analgesia should be based on the evidence for that particular surgical procedure. For example, thoracic epidural reduces movement-related pain, ileus and postoperative nausea and vomiting compared to other analgesia after open colorectal procedures. However, it is clearly not appropriate for minimally invasive laparoscopic abdominal procedures with limited tissue injury. The modern age of laparoscopic surgeries were ushered in with the incorporation of miniature video camera attached to the eye place of laparoscope, allowing multiple assistant to view the operative field from the same vantage point.  The development and potential for advanced laparoscopic cholecystectomy and diagnostic laparoscopy was recently reviewed by hunter.

Opioids have been administered for hundreds of years to calm anxiety and to reduce the pain associated with surgery. The discovery of newer opioids, these continue to occupy an important place in the field of postoperative pain management. Now a days apart from the traditional opioid analgesics, use of parenteral and oral NSAIDS (Non-steroidal anti-inflammatory drugs) is becoming more popular. Among NSAIDS, the drug diclofenac is being used widely for postoperative analgesia by the anaesthesiologists.  Diclofenac is an analgesic-antipyretic-anti-inflammatory drug. It inhibits prostaglandin synthesis by inhibiting cyclooxygenase enzyme. Though we have been using parenteral diclofenac (Intramuscular) most often, suppository and intravenous use is also possible. It can be administrated by Transdermal route also. The advantages of this route are painless, non-irritant, increased bioavailability and it can be applied for 24 hours. Though transdermal route has its own advantages there are no studies to compare this route along with intramuscular route.

Ketoprofen is a potent non-steroidal anti-inflammatory agent, widely used for the symptomatic treatment of inflammatory syndromes such as rheumatoid arthritis, osteoarthritis and acute gouty arthritis. Because of its gastric irritation after oral administration, many topical formulations of ketoprofen such as cream and gel were developed. Transdermal drug delivery system is one of the novel drug delivery systems. It has many advantages over the other dosage forms such as providing extended therapy with a single application, thus leading to good patient compliance.  There was very few evidence regarding this study. So the present study was undertaken in patients undergoing elective laproscopic surgeries under general anaesthesia with an objective to evaluate the efficiency of transdermal diclofenac patch with transdermal ketoprofen patch.

 

MATERIALS AND METHODS

The present study was undertaken at Shri M. P. Shah Govt. Medical College and Guru Gobind Singh Govt. Hospital, Jamnagar. Approval from institutional ethical committee was sought before study.

Normal adult patients of either sex, without any co-morbidity, admitted for elective laproscopic abdominal surgeries between ages of 18 to 60 years with ASA grade: I and II, weight ranging between 40 to 80 kg and duration of surgeries up to 90 minutes were included in the study. Total 60 patients were included in the study after explaining purpose and procedure of study and written informed consent of the patients. Patient with history of alcohol abuse, asthma, underlying neurological, cardiovascular, psychiatric disease, hepatic or renal disorders were excluded from the study.

All patients were divided equally in two groups, 30 patients in each group:

GROUP- D (n=30) - Patients received transdermal patch of diclofenac sodium (each patch of 50 cm² contains 100 mg)

GROUP-K (n=30)-Patients received transdermal patch of ketoprofen (each patch of 70 cm² contains 20 mg)

Transdermal diclofenac sodium patch/ transdermal ketoprofen patch (in Acute post-operative pain) was applied on intact, clean, dry and hairless skin, before application of patch site was clean with clear water and dried. Patch was applied to either side of chest wall, before extubation or immediately after dressing. All patients were monitored for haemodynamic changes in pulse rate (per minute), systolic blood pressure (mm Hg), diastolic blood pressure (mm Hg), Respiratory Rate (per minute), SPO2 (%) before premedication, before induction, intra-operatively ( at 0 min ,10 min, 20 min, 30 min, 60 min, 90 min, 120 min ), post-operatively (at 0 hr, 1 hr, 2 hr, 4 hr, 6 hr,8 hr and 12 hr). Pre-anaesthetic assessment was done (as per proforma) on evening before surgery. A routine examination was done by assessing- General condition, Nutritional status, weight, Airway assessment, complete examination of cardiovascular and respiratory system. Premedication Inj.Glycopyrrolate 0.2mg intramuscular, Inj. Pentazocine 30 mg intramuscular, Inj. Promethazine 25 mg intramuscular and Inj. Ondensetron 4mg intravenous slowly. In operation theatre ECG, NIBP, SpO2 were applied and 18 G intravenous cannula was inserted into a suitable vein and secured. Pre-oxygenation was done with 100% oxygen for 5 minute and Inj. Xylocard 2mg/kg was given intravenous slowly. Inj. Propofol intravenous.2.5mg/kg and Inj. Scoline intravenous 2mg/kg were used as Induction agents. Endotracheal Intubation done with oral portex cuffed endotracheal tube with appropriate size according to glottic opening. Maintenance was done with oxygen [33%], nitrous oxide [66%], Inj. Atracurrium, Inhalational agent, IPPV according to patient need. Reversal of anaesthesia was achieved using inj. glycopyrolate 8 µg/kg + inj neostigmine 0.05 mg/kg intravenous. Endotracheal tube was removed only after establishment of all reflexes, adequate muscle power and consciousness. All patients were monitored for onset of pain relief, duration of analgesia of test drug by visual analogue scale and time when rescue analgesia. Rescue analgesia was given when Visual analogue scale was ≥ 3 then rescue analgesia inj. Tramadol (1mg/kg) was given intramuscularly, post-operatively. Adverse effects (Local -Dermatitis, Erythema, Purities Hyperhidrosis and systemic - Gastritis, Nausea, Vomiting, Dizziness) post-operatively were also observed. Pain scores were evaluated using a 0–10 VAS (0 - no pain to 10 - worst pain imaginable).  Severity of pain was determined by using the visual analogue scale. It uses a straight line with extremities of pain intensity on either end. The line is typically 10 cm long with one end defined as “no pain” and the other end being “excruciating unbearable pain”. To assist in describing the intensity of pain, words can be placed along the scale (e.g., mild, moderate, or severe). Such descriptors can help to orient the patient for the degree of pain; this particular variation of the VAS has been known as a graphic rating scale. Inj. Tramadol was used as rescue analgesia when VAS score>4.

Statistical Analysis

Statistical analysis was employed using different methods for different data subsets. A comparison of variables between two groups was done by using unpaired Student̔ t- test and Chi- square test to find the p- value. A P-value of <0.05 was considered to be statistically significant.

 

OBSERVATIONS AND RESULTS

The present clinical study was done to evaluation of efficacy to transdermal diclofenac sodium patch versus transdermal ketoprofen patch for relief of acute post-operative analgesia in laproscopic abdominal surgeries undergoing general anaesthesia.

GROUP- D included 30 patients who received transdermal patch of diclofenac sodium while GROUP-K included 30 patients who received transdermal patch of ketoprofen.

Table 1: Mean demographic data in group D and group K

Table 1 shows demographic profile. There was no statistically significant difference between the two groups of patients in terms of age, weight and male/female ratio (P> 0.05).

 

Table- 2: Comparison of mean Pulse rate per minute status of patients in Group D and Group K

The table 2 shows the changes in mean pulse rate (per minute) at different time interval. The difference was statistically insignificant (p>0.05).

Table 3: Comparison of mean Systolic blood pressure (mmHg) of patients in Group D and Group K

The table 3 shows the changes in mean systolic blood pressure at different time interval. The difference was statistically insignificant (p>0.05).

 

Table 4: Comparison of Mean Diastolic Blood Pressure (mmHg) status of patients in Group D and Group K

The table 4 shows the changes in mean diastolic blood pressure at different time interval. The difference was statistically insignificant (p>0.05).

Table 5: Comparison of Mean Arterial Blood Pressure (mmHg) status of patients in Group D and Group K

The table 5 shows the changes in mean arterial blood pressure at different time interval. The p value was ≥0.05, which was insignificant. Mean duration of analgesia, in Group D was 9.2 ± 0.08216 while in Group K, it was 11.33 ± 0.0584. The difference was statistically significant (p<0.05)

 

Table 6: Mean visual analogue scale (VAS) data in Group D and Group K

Table no 6 shows mean visual analogue scale at different interval post-operatively, in Group D and in Group K. The difference was statistically significant at 2 hr, 4 hr, 6 hr, 8 hr, and 12 hr post-operatively. (p<0.05)

Table 7: Complication in both Group D and Group K

Table no 7 shows that the complications occurrence in both group were insignificant. In Group D, 21 (70%) required of rescue analgesia and in Group K, the number was 4 (13.33%). The difference was statistically significant (p<0.05).

 

 

 

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