1 Department of Family Practice, University of British Columbia, Canada
2 To whom correspondence should be addressed at: 1013-750 West Broadway, Vancouver, BC V5Z 1H9, Canada. Email: ellenwiebe{at}telus.net
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Abstract |
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Key words: abortion/fentanyl/pain/paracervical block/randomized controlled trial
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Introduction |
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In a report of 825 women having first trimester abortions, the mean pain score was 5.4 on an 11-point scale. This indicates a need for better analgesia. Depression and anxiety scores were positively related to pain perception (Rawling and Wiebe, 2001). A study of 109 women having first trimester abortions showed that dysmenorrhoea, depression and anxiety were positively related to pain, and age was negatively related to pain (Belanger et al., 1989
). A report of 1055 women having first trimester abortions found that gestational age was positively related to pain, age was negatively related and women who had had previous vaginal deliveries reported less pain (Borgatta and Nickinovich, 1997).
Other studies have looked at ways to improve pain control during abortion, and the following methods reduced pain scores significantly: deep rather than superficial injections, buffering the lidocaine, pre-operative non-steroidal anti-inflammatory drug (NSAID) and adding fentanyl i.v. (Wiebe, 1992; Wiebe and Rawling, 1995
; Rawling and Wiebe, 2001
). The following methods were not helpful: different local anaesthetics, waiting between injection and procedure, and increased concentration of local anaesthetic (Wiebe, 1992
; Wiebe et al., 1996
, 2003
; Glantz and Shomento, 2001
).
Pain is subjective and difficult to quantify. A comparison of commonly used pain scales indicated that the 11-point numeric pain scale was as sensitive to changes in clinical pain as the visual analogue scale (Jensen et al., 1998). It is practical and valid in a setting where many patients have English as a second language and has been used in many studies on abortion (Wiebe, 1992
; Wiebe et al., 1996
, 2003
). Clinically significant changes in pain are even more difficult to quantify. An emergency room study indicated that 13 points on a 101-point scale was the minimum difference patients could discriminate (Todd et al., 1996
). One study used 18 mm on a 100 mm VAS and another used 3 points on a 11-point scale as the clinically significant difference (Tucker et al., 1993
; Todd and Funk, 1996
). When patients were asked what difference they would want from an analgesic, they said 2 points on an 11-point pain scale (Rawling and Wiebe, 2001
). The outcome measure chosen for this study is the 11-point numeric pain scale. On the basis of the above evidence, the clinically important difference for this study was chosen to be 1.5 on the 11-point scale.
The most commonly used drugs for abortion anaesthesia are lidocaine for para-cervical block and fentanyl with midazolam i.v. for the conscious sedation (Lichtenberg et al., 2001). This conscious sedation requires i.v. access and has side effects such as nausea and risks such as respiratory depression. Narcotics have been added to nerve blocks in many situations, such as axillary blocks for hand surgery (Karakaya et al., 2001
) and spinals for obstetrics (Choi et al., 2000
), with very good results. There are fewer side effects and risks and yet good analgesia. There was an anecdotal report of this technique of adding fentanyl to the para-cervical block at the National Abortion Federation meeting April 2003. There are no reports of the use of narcotics in para-cervical blocks in the medical literature. Potentially, we could improve analgesia without increasing side effects and risks, and we would not require i.v. access.
The goal of this study was to improve pain control in abortion by comparing para-cervical block plus either i.v. or intra-cervical (i.c.) fentanyl with respect to pain scores and side effects during surgical abortion.
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Subjects and methods |
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The standard procedure before a surgical abortion was applied, including a relevant medical, gynaecological and obstetric history, and a physical exam including a pelvic exam, an ultrasound and relevant laboratory testing.
After receiving information and signing the consent form, the women received a sequential study number from the study logbook. Clinic chart numbers were logged and the study number noted in the clinic chart. Randomization occurred by using a table of random numbers generated by computer and a research assistant prepared the numbered syringes for the study, which contained 100 µg of fentanyl or saline. All women received an indwelling i.v. catheter. The women in the i.v. group received 100 µg of fentanyl in the i.v and 2 ml of saline added to the lidocaine of the para-cervical block. The i.c. group received 2 ml of saline in the i.v. and 100 µg of fentanyl added to the lidocaine of the para-cervical block. Neither the operating doctor, patient or theatre nurse were aware of which syringe had the narcotic. There were five physicians involved in the study and each used their usual technique and dose of lidocaine for the para-cervical block. The dose varied from 50 to 125 mg (1025 ml of 0.5%) and all doctors used multiple sites of injection with a combination of both deep and superficial injections (variations of the technique described in a previous study) (Borgatta and Nickinovich, 1997).
The abortion procedure was done as usual with vacuum curette and Berkley suction. Pre-operative misoprostol was not used for cases of <13 weeks gestation. Vasopressin (2 U) was added to the para-cervical blocks. If women still experienced pain, they were offered an additional 50 µg of i.v. fentanyl and/or more lidocaine (without fentanyl). The worst pain experienced during dilation and during the rest of the procedure was rated on an 11-point verbal pain scale by asking, On a scale of 0 to 10 where 0 is no pain and 10 is pain as bad as it can be, what was that like for you?. These scores were recorded by the theatre nurse. In the recovery room, women were asked about side effects such as nausea and acceptability of the procedure by the recovery room nurse.
Demographic information was recorded and included the factors known to influence abortion pain such as age and previous vaginal deliveries. Women were asked about dysmenorrhoea, pre-operative anxiety and depression.
The two groups were compared with respect to pain, additional pain and nausea medication, side effects and acceptability.
Statistics
Before starting the study, a 1.5 unit difference was chosen to be a clinically important difference (Rawling and Wiebe, 2001). A sample size of 85 per group was determined to be sufficient to detect a 1.5 unit difference (SD = 3.0) in the pain scores between the treatment groups with 90% power and 5% level of significance. The data were entered into SPSS and analysed using two-sample t-tests and MannWhitney tests.
The University of British Columbia Clinical Research Ethics Board approved this study (C03-0439).
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Results |
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Discussion |
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The mean pain score for dilation in the i.v. group was 4.7, which means that the amount of pain women experience during abortions is still unacceptable to many women and many women fear the pain. Since our clinic does not routinely use i.v. access if women do not request conscious sedation, we had hoped we could have a good alternative analgesic for women who are very anxious about i.v. needles.
One limitation of the study was that women who had been given midazolam may have impaired memory and not answer the questions accurately. Since they were only expected to remember the past few minutes for the pain and side effect questions, this may not have been a concern. We did not weigh the women and weight may be a factor in the effective dose of fentanyl.
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Acknowledgements |
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References |
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Submitted on December 8, 2004; resubmitted on February 22, 2005; accepted on March 3, 2005.
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