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 Table of Contents  
ORIGINAL ARTICLE
Year : 2016  |  Volume : 30  |  Issue : 2  |  Page : 122-126

Postspinal analgesic effect of transdermal fentanyl patch (2.5 mg and 5 mg) in abdominal hysterectomy: A randomized double-blind control study


1 Department of Anaesthesia, SMS Medical College and Hospital, Jaipur, Rajasthan, India
2 Department of PSM, SMS Medical College and Hospital, Jaipur, Rajasthan, India
3 Department of Orthopaedics, SMS Medical College and Hospital, Jaipur, Rajasthan, India

Date of Web Publication18-Jul-2016

Correspondence Address:
Ritika Gupta
House No: 22756, Street No: 11/6, Power House Road, Bathinda - 151 001, Punjab
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0970-5333.186469

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  Abstract 

Background and Aims: The use of transdermal patches to deliver drugs systemically for postoperative analgesia offers lots of pharmacological and nonpharmacological advantages over the conventional enteral and parenteral drug therapies. Aim of this study was to assess the difference in mean duration and quality of postspinal analgesia in patients underwent elective abdominal hysterectomy. Methods: Sixty patients of American Society of Anesthesiologists Grade I and II undergoing elective abdominal hysterectomy were randomized into three groups of 20 each using chit in box method (Group I control, Group II 2.5 mg fentanyl patch, and Group III 5 mg fentanyl patch). The ANOVA test and post hoc test were used for continuous data and Chi-square test was used for count data. Results: The mean difference of visual analog scale score were significantly low in Group III and Group II (P = 0.00). The mean total duration of analgesia was more in Group III and Group II (P = 0.00). The requirement of rescue analgesic dose was significantly low in Group II and no rescue analgesic needed in Group III (P = 0.00). No significant side effects were noted. Conclusions: Transdermal fentanyl patch (TFP) (50 mcg/h) provides better postoperative analgesia than TFP (25 mcg/h) and placebo patch with significant reduction of requirement of rescue analgesic dose.

Keywords: Analgesia, fentanyl, transdermal patch


How to cite this article:
Gupta R, Ahmed F, Chatterjee R, Rathore M, Aggarwal A. Postspinal analgesic effect of transdermal fentanyl patch (2.5 mg and 5 mg) in abdominal hysterectomy: A randomized double-blind control study. Indian J Pain 2016;30:122-6

How to cite this URL:
Gupta R, Ahmed F, Chatterjee R, Rathore M, Aggarwal A. Postspinal analgesic effect of transdermal fentanyl patch (2.5 mg and 5 mg) in abdominal hysterectomy: A randomized double-blind control study. Indian J Pain [serial online] 2016 [cited 2020 May 30];30:122-6. Available from: http://www.indianjpain.org/text.asp?2016/30/2/122/186469


  Introduction Top


Adequate pain management during surgery and also in the postoperative period is essential to accelerate functional recovery and to enabling patient to return to their normal activity more quickly. It has been established that instead of single approach, multimodal approach to the adequate pain management with parenteral opioids, regional techniques, peripheral nerve block, nonsteroidal anti-inflammatory drugs etc., are more effective as well as safe to the patients. The transdermal fentanyl patch (TFP) has many advantages: It can easily adhere to the skin, obviating an intravenous (IV) line, so there is little risk of infection, it is easily procured and costs less than a patient-controlled analgesia pump, and it needs no programming, so no human error occurs. [1],[2] It may be a good alternative in acute pain management.

The efficacy of TFPs has been established in chronic pain relief, but very few studies are available for their role in acute pain management. Hence, we designed this study to determine efficacy of TFP for acute postoperative analgesia in patients undergoing abdominal hysterectomy after spinal anesthesia.

The hypothesis of study was Intrathecal bupivacaine +5 mg TFP has better analgesic and anesthetic effect than intrathecal bupivacaine alone and intrathecal bupivacaine +2.5 mg TFP in terms of duration of analgesia


  Methods Top


This study was conducted in the Department of Anesthesia, at Tertiary Care Center. This was a prospective, randomized, double-blind, study included sixty patients, of the American Society of Anesthesiologists Grade I and II, age 30-60 years, body weight 45-75 kg who underwent elective abdominal hysterectomy. Prior ethical permission was taken from our Institutional Ethical Committee.

The trial was first done by 2.5 mg patch applied 2 h before spinal but we found that there was pain after the effect of spinal went off which means that the analgesic plasma concentration of fentanyl was not reached when fentanyl patch was applied 2 h before spinal. Thus the time was increased to 3 h; no other changes were made in inclusion criteria.

A written informed consent was obtained from sixty female patients. The randomization was done by chit in box method. All the patients undergoing elective abdominal hysterectomy were thoroughly examined during the preanesthetic visit the day prior to surgery which included history, physical examination and checking the vital parameters (blood pressure, pulse, respiratory rate [RR] and oxygen saturation [SpO 2 ]), examination of respiratory, cardiac, central nervous system, and alimentary system. Patients having anemia (Hb <10 g%), compromised renal, cardiac, endocrine or respiratory status, failed spinal anesthesia, any contraindication of spinal anesthesia and refusal of consent were excluded from the study.

On the day of surgery, 3 h before giving subarachnoid block, vital parameters were recorded in preanesthetic room and transdermal patches were applied on anterior chest wall according to the group (Group I - placebo patch, Group II - 2.5 mg TFP and Group III - 5 mg TFP).

The visual analog scale (VAS) scoring system was explained to all the patients. The VAS consisted of a 100 mm horizontal paper strip with two endpoints labeled "No pain" and "Worst pain ever." When the patient complained of pain in ward or recovery room, she was asked to mark the strip at a point that corresponds to the level of pain intensity, she presently felt.

All the patients were fasted for at least 6 h before the procedure. In operating room all the routine monitors were attached and the preoperative baseline readings of noninvasive blood pressure, pulse rate (PR), and SpO 2 were noted. After securing an IV access using an 18-Gauge IV cannula all patients irrespective of the group they belonged to were preloaded with Ringer's lactate 15 mL/kg over 10 min. All the patients were premedicated with injection midazolam 1 mg IV. Under all aseptic precautions, spinal anesthesia was performed in the operating room at the L3-L4 interspace, with the patient in the left lateral position using a 25-Gauge (BD Spinal Needle). A volume of 3 mL of 0.5% hyperbaric bupivacaine was injected over 30 s. The patient was placed in supine position with a head down tilt immediately after spinal injection to achieve highest level of block up to T5 or T6. An indwelling urinary catheter was inserted before the start of the operation. Intraoperative fluid management was done according to the blood loss and hemodynamic parameters.

Intraoperatively, regular checkup of blood pressure, PR, saturation, and RR were done at 2 min, 5 min, 10 min, 15 min, 30 min, 60 min, 120 min interval.

At the end of surgery patient was shifted to postanesthesia recovery room. Prespecified primary outcome was pain relief and it was assessed by VAS score at rest. Baseline analgesia (on a 100 point VAS score) was recorded postoperatively. VAS score was recorded every 30 min for the first 4 h, after that every 4 h for first 24 h, and 8 hourly for next 48 h. Injection diclofenac sodium 75 mg IM in gluteal region is given as rescue analgesic when the VAS is 30. At that time, VAS score was noted and duration of effective analgesia was measured as the time from intrathecal drug administration to VAS score 30. Vital parameters such as noninvasive systolic blood pressure (SBP), diastolic blood pressure (DBP), mean blood pressure (MBP), heart rate, RR, and SpO 2 were recorded every half an hour up to 4 h. Complications such as nausea, vomiting, respiratory depression, and pruritus were also noted. Nausea and vomiting were managed by injection ondansetron 4 mg/8 mg IV and respiratory depression by naloxone 0.4 mg IV. The doses of fentanyl patch used were small, i.e., 5 and 2.5 mg only, thus sedation score was not measured.

Double blinding method was used by ensuring the anesthetist giving spinal anesthesia and applying patches was different from investigator who observed the postspinal analgesic effects. Both were not aware of the group of patient (both blinded).

Patches of same size and appearance but different composition (placebo, 2.5 mg fentanyl patch, and 5 mg fentanyl patch) were applied. Placebo patch was prepared using same size and same color sticker.

The sample size required to verify the expected least difference in mean VAS score of 2.5 (±2.29) in all three groups at 95% confidence interval and 80% power is 17 in each group that was rounded off to 20 in all three groups.

Statistical analysis was performed by the Primer program for windows. Continuous data were summarized in form of mean and standard deviation. The difference in means was analyzed using ANOVA test and post hoc test. Count data were summarized in the form of proportions. The difference in proportions was analyzed using Chi-square test. The level of significance was kept 95% for all statistical analysis. There was no exclusion or losses of patient after randomization [Figure 1].
Figure 1: Participant flow of study

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  Results Top


The demographic profile (age and weight) of patients belonging to the three groups was similar and the groups were comparable with each other. The difference in duration of surgery among all three groups was statistically insignificant [Table 1].
Table 1: Demographic profile


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VAS score were lower in Group III and Group II and mean difference was statistically significant (P = 0.00) after 90 min [Table 2].
Table 2: Mean of visual analogue scale score


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The difference in mean total duration of analgesia was statistically significant among all three groups (P = 0.00) but difference between Group II and Group III was not significant [Table 3].
Table 3: Mean of total duration of analgesia


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No patient in Group III (TFP 5 mg) experienced VAS score >30 with mean duration of analgesia 4320 ± 0 min but 3 patients in Group II (TFP 2.5 mg) and 19 patients in Group I (placebo patch) experienced VAS 30 with mean total duration of analgesia as 4112 ± 930.65 min and 224.6 ± 43.83 min, respectively, and they were given injection diclofenac IM 8 hourly as rescue analgesia (P = 0.00 significant) [Table 3] and [Table 4].
Table 4: Rescue dose


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The differences in SBP, DBP, and MBP among all three groups become statistically significant on application of spinal anesthesia (P < 0.05). The difference in mean PR and mean RR among all three groups become statistically significant after 90 min of application of spinal anesthesia (P < 0.05). The difference in mean SpO 2 among all three groups was statistically insignificant throughout the study (P > 0.05). Two point segment regressions in Group I was 94.7 ± 22.02, in Group II was 117.9 ± 26.82, and in Group III was 110.4 ± 23.23. Nausea and vomiting were noted as side effects in one patient in Group II and three patients in Group III (P > 0.05) [Table 5].
Table 5: Postoperative complications


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  Discussion Top


In this study, total duration of analgesia got prolonged in 5 mg and 2.5 mg fentanyl patch groups as compared to placebo group. Rescue analgesic requirement were less in fentanyl 5 mg and 2.5 mg groups. This benefit was not associated with significant hemodynamic variations and other side effects. Postoperative recovery was uneventful.

Preemptive analgesia is defined as a treatment that is initiated before surgery in order to prevent the establishment of central sensitization evoked by the incisional and inflammatory injuries occurring during surgery and in the early postoperative period. [3]

It has been reported that postoperative analgesia is satisfactory when the plasma level of fentanyl is maintained at 1-3 ng/ml. [4],[5],[6] This range of fentanyl concentrations can be maintained for up to 48 h with a patch delivering 25, 50, 75, and 100 mcg/h. [7],[8],[9],[10] Hence, in our study, fentanyl patch 2.5 mg and 5 mg were used which delivers fentanyl at the rate of 25 mcg/h and 50 mcg/h, respectively.

Miguel et al. studied the pharmacokinetics of fentanyl patch in general anesthesia by applying two patches (40 and 60 cm 2 ) approximately 2 h before gynecological exploratory laprotomy. They found that therapeutic fentanyl concentrations were achieved 3-6 h after applying patch. [11]

Broome et al. and Lehmann et al. conducted similar studies in general anesthesia with patch applied at 3 h and 60 min before operation, respectively. Both concluded that efficacy of transdermal fentanyl is related to the rate of fentanyl delivery. Higher rates were associated with lower VAS score despite reduced rescue analgesic requirements and decreased RR with higher TFP dosage. [12],[13] Fentanyl patch offers an easy and safe treatment option as a part of multimodal analgesia with few adverse effects. [14],[15],[16]

Sathitkarnmanee et al. assessed the efficacy of patch (50 mcg/h) in total knee arthroplasty under spinal anesthesia applied 10-12 h before surgery, which decreased morphine consumption and pain scores during the first 48 h after surgery. [2]

More recently, Matsumoto et al. concluded that a 12.5 mcg/h TFP can improve postoperative pain relief and promotes early functional recovery following total knee arthroplasty. [17]

Our results are similar to these studies. [2],[11],[12],[13],[14],[15],[16],[17]

By contrast some studies reported that fentanyl patch did not significantly relieve postoperative pain. [3],[18],[19] In these studies, the TFP was placed just before or within 2 h of surgery. For TFPs to be effective, its serum level must plateau. We applied TFP 3 h before surgery so that plateau analgesic serum fentanyl concentration is reached just before the sensory effect of subarachnoid block went off and patient did not experienced pain.

Since our study was done in spinal anesthesia and relatively low dose of fentanyl patch were used so incidence of side effects was not significant and also respiratory depression was not encountered as in other studies. [12],[13],[14],[15],[16],[17]

The adverse effects of TFPs are dose-dependent, as with other narcotic administration. Sedation scores do not increase, albeit reduction in the RR rise, with doses up to 75 μg/h. [12],[14]


  Conclusions Top


Fentanyl patch (2.5 mg [25 mcg/h] and 5 mg [50 mcg/h]) applied 3 h before surgery can be used as a postoperative analgesia in patient undergoing elective abdominal hysterectomy and can reduce the requirement of rescue analgesic without any significant complications. The patients with fentanyl patch were more comfortable and pain free as evidenced by lower VAS score.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
  References Top

1.
Minville V, Lubrano V, Bounes V, Pianezza A, Rabinowitz A, Gris C, et al. Postoperative analgesia after total hip arthroplasty: Patient-controlled analgesia versus transdermal fentanyl patch. J Clin Anesth 2008;20:280-3.  Back to cited text no. 1
    
2.
Sathitkarnmanee T, Tribuddharat S, Noiphitak K, Theerapongpakdee S, Pongjanyakul S, Huntula Y, et al. Transdermal fentanyl patch for postoperative analgesia in total knee arthroplasty: A randomized double-blind controlled trial. J Pain Res 2014;7:449-54.  Back to cited text no. 2
    
3.
Kissin I. Preemptive analgesia. Anesthesiology 2000;93:1138-43.  Back to cited text no. 3
    
4.
Rowbotham DJ, Wyld R, Peacock JE, Duthie DJ, Nimmo WS. Transdermal fentanyl for the relief of pain after upper abdominal surgery. Br J Anaesth 1989;63:56-9.  Back to cited text no. 4
    
5.
Calis KA, Kohler DR, Corso DM. Transdermally administered fentanyl for pain management. Clin Pharm 1992;11:22-36.  Back to cited text no. 5
    
6.
Duthie DJ, Rowbotham DJ, Wyld R, Henderson PD, Nimmo WS. Plasma fentanyl concentrations during transdermal delivery of fentanyl to surgical patients. Br J Anaesth 1988;60:614-8.  Back to cited text no. 6
    
7.
Lehmann KA, Zech D. Transdermal fentanyl: Clinical pharmacology. J Pain Symptom Manage 1992;7 3 Suppl: S8-16.  Back to cited text no. 7
    
8.
Gourlay GK, Kowalski SR, Plummer JL, Cherry DA, Gaukroger P, Cousins MJ. The transdermal administration of fentanyl in the treatment of postoperative pain: Pharmacokinetics and pharmacodynamic effects. Pain 1989;37:193-202.  Back to cited text no. 8
    
9.
Gourlay GK, Kowalski SR, Plummer JL, Cherry DA, Szekely SM, Mather LE, et al. The efficacy of transdermal fentanyl in the treatment of postoperative pain: A double-blind comparison of fentanyl and placebo systems. Pain 1990;40:21-8.  Back to cited text no. 9
    
10.
Sandler A. Transdermal fentanyl: Acute analgesic clinical studies. J Pain Symptom Manage 1992;7 3 Suppl: S27-35.  Back to cited text no. 10
    
11.
Miguel R, Kreitzer JM, Reinhart D, Sebel PS, Bowie J, Freedman G, et al. Postoperative pain control with a new transdermal fentanyl delivery system. A multicenter trial. Anesthesiology 1995;83:470-7.  Back to cited text no. 11
    
12.
Broome IJ, Wright BM, Bower S, Reilly CS. Postoperative analgesia with transdermal fentanyl following lower abdominal surgery. Anaesthesia 1995;50:300-3.  Back to cited text no. 12
    
13.
Lehmann KA, Einnolf C, Eberlein HJ, Nagel R. Transdermal fentanyl for the treatment of pain after major urological operations. A randomized double-blind comparison with placebo using intravenous patient-controlled analgesia. Eur J Clin Pharmacol 1991;41:17-21.  Back to cited text no. 13
    
14.
Caplan RA, Ready LB, Oden RV, Matsen FA 3 rd , Nessly ML, Olsson GL. Transdermal fentanyl for postoperative pain management. A double-blind placebo study. JAMA 1989;261:1036-9.  Back to cited text no. 14
    
15.
Merivirta R, Äärimaa V, Aantaa R, Koivisto M, Leino K, Liukas A, et al. Postoperative fentanyl patch versus subacromial bupivacaine infusion in arthroscopic shoulder surgery. Arthroscopy 2013;29:1129-34.  Back to cited text no. 15
    
16.
Hosseini H, Kargar S, Shiryazdi SM, Kargar S, Rezaie F, Neamatzadeh H. Fentanyl transdermal patch (Durogesic® D-TRANS) for post abdominal laparotomy analgesia: A double blind randomized study. Minerva Chir 2015;70:401-8.  Back to cited text no. 16
    
17.
Matsumoto S, Matsumoto K, Iida H. Transdermal fentanyl patch improves post-operative pain relief and promotes early functional recovery in patients undergoing primary total knee arthroplasty: A prospective, randomised, controlled trial. Arch Orthop Trauma Surg 2015;135:1291-7.  Back to cited text no. 17
    
18.
Sevarino FB, Naulty JS, Sinatra R, Chin ML, Paige D, Conry K, et al. Transdermal fentanyl for postoperative pain management in patients recovering from abdominal gynecologic surgery. Anesthesiology 1992;77:463-6.  Back to cited text no. 18
    
19.
Merivirta R, Pitkänen M, Alanen J, Haapoja E, Koivisto M, Kuusniemi K. Postoperative pain management with transdermal fentanyl after forefoot surgery: A randomized, placebo-controlled study. J Pain Res 2015;8:39-45.  Back to cited text no. 19
    


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    Tables

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



 

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