Abstract

Background

This is an updated version of the original Cochrane Review published in Issue 4, 2008 of The Cochrane Library. There is variation in the use of pain relief for managing pain or discomfort of femoral sheath removal. The efficacy of pain relief to promote comfort during this procedure or to reduce the incidence of vascular and procedural complications has not been established.

Objectives

To assess the efficacy of pain relief used to manage pain of femoral sheath removal in adults after interventional cardiology.

To determine if pain relief influences rates of complications associated with this procedure.

Search methods

We brought the search up to date by searching the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, CINAHL, Australasian Medical Index, Web of Knowledge and Digital Dissertations up to June 2011.

Selection criteria

Randomised studies comparing opioid, local anaesthetic, anxiolytic, no treatment or placebo administered for alleviation of pain or discomfort of the femoral sheath removal procedure.

Data collection and analysis

Two review authors assessed study quality and extracted data. We calculated mean differences (MD) where meta‐analysis was feasible. We collected adverse effects information.

Main results

Four studies involving 971 participants were included. All results were reported using a zero to 10 pain scale. Three studies (four treatment arms) involving 498 participants compared subcutaneous lignocaine with control with no significant difference between pain scores; MD 0.12 (95% confidence interval (CI) ‐0.46 to 0.69). Two studies (three treatment arms) involving 399 participants compared intravenous pain regimens with control. A significant reduction in pain score was observed with intravenous opioid and anxiolytic; MD ‐0.90 (95% CI ‐1.54 to ‐0.27). One study involving 60 participants compared levobupivacaine with placebo. Longer‐acting local anaesthetic significantly lowered the pain score by a MD of ‐1.10 (95% CI ‐1.26 to ‐0.94). The data are insufficient to identify any influence of pain regimens on vascular and procedural complication rates. No studies reported appropriate blinding for all treatment arms. The largest study, comprising 661 participants, was unblinded with a quality score of two out of five.

Authors' conclusions

No new studies have been found since the last version of this review and the conclusions therefore remain the same. Intravenous pain regimens and levobupivacaine may have greater efficacy when compared to control for the management of pain related to femoral sheath removal. However, a definitive study is still required because the clinical difference is small. There is no evidence to support the use of subcutaneous lignocaine. There is insufficient evidence to determine if pain relief influences the rate of complications. One new study has been included as a 'study awaiting assessment' as we await further information from the study authors.

Author(s)

Cynthia Wensley, Bridie Kent, Mike B McAleer, Sue M Savage, Jim T Stewart

Abstract

Plain language summary

Pain relief for removal of femoral sheath after cardiac procedures

Procedures for the non‐surgical management of coronary heart disease include balloon angioplasty (mechanically widening a narrowed or obstructed blood vessel) and intracoronary stenting (a device to support the blood vessel to keep it open). At the start of each procedure an introducer sheath is inserted through the skin (percutaneously) into an artery, frequently a femoral artery in the groin. This allows the different catheters used for the procedure to be exchanged easily without causing trauma to the skin. At the end of the procedure the sheath is removed and, if the puncture site is not 'sealed' using a device closure, firm pressure is required over the site for 30 minutes or more to control any bleeding and reduce vascular complications. Removing the sheath and the firm pressure required to control bleeding can cause pain, although this is generally mild. Some centres routinely give pain relief before removal, such as intravenous morphine, or an injection of a local anaesthetic in the soft tissue around the sheath (called a subcutaneous injection). Adequate pain control during sheath removal is also associated with a reduced incidence of a vasovagal reaction, a potentially serious complication involving a sudden drop of blood pressure and a slowed heart rate.

In this systematic review of randomised controlled trials four studies were reviewed. Three studies involving 498 participants compared subcutaneous lignocaine, a short‐acting local anaesthetic, with a control group (participants received either no pain relief or an inactive substance known as a placebo). Two studies involving 399 people compared intravenous opioids (fentanyl or morphine) and an anxiolytic (midazolam) with a control group. One study involving 60 people compared subcutaneous levobupivacaine, a long‐acting local anaesthetic, with a control group. Intravenous pain regimens and subcutaneous levobupivacaine appear to reduce the pain experienced during femoral sheath removal. However, the size of the reduction was small. A significant reduction in pain was not experienced by participants who received subcutaneous lignocaine or who were in the control group. There were insufficient data to determine a correlation between pain relief administration and either adverse events or complications. Some patients may benefit from routine pain relief using levobupivacaine or intravenous pain regimens. Identifying who may potentially benefit from pain relief requires clinical judgement and consideration of patient preference. The mild level of pain generally experienced during this procedure should not influence the decision as some people can experience moderate levels of pain with the conventional wound care.

Author(s)

Cynthia Wensley, Bridie Kent, Mike B McAleer, Sue M Savage, Jim T Stewart

Reviewer's Conclusions

Authors' conclusions 

Implications for practice 

The implications are unchanged from the original review.

Intravenous pain regimens and subcutaneous levobupivacaine appear to produce reductions in pain score not seen with subcutaneous lignocaine or control. However, interpretation of the clinical relevance of these findings is difficult as the size of the reduction is small and the size of a clinically important reduction in procedural pain is not known. This review did not demonstrate any correlation between pain relief administration and either adverse events or complications.

In the absence of a definitive finding, clinical judgement and consideration of patient preference is required to identify those who may potentially benefit from pain relief. The mild level of pain generally experienced during this procedure should not influence the decision to consider pain relief as it is evident from the range of pain scores that some people experience moderate levels of pain.

Clinical judgement is informed by an assessment of factors that are thought to impact on the individual's pain experience. During sheath removal these factors may include the patient's past experiences of procedure‐related pain, the level of anxiety, the effectiveness of basic comfort measures prior to the procedure, existing vascular complications such as haematoma, the extent of patient preparation, the patient‐practitioner therapeutic relationship and the clinical setting. However, information on how these aspects may influence the participant's experience is lacking. Where analgesic requirement is anticipated, administration before the procedure rather than in reaction to breakthrough pain is considered good practice.

Implications for research 

To determine the effectiveness of intravenous pain regimens further evaluation is warranted by means of an adequately powered randomised controlled trial with appropriate blinding. The success of blinding should be tested and reported. A clinically relevant threshold for pain reduction is required to interpret the results. Given the higher pain intensity reported in trials using no intervention (that is no placebo) as a control, inclusion of a 'no intervention' arm may be of value. The extent to which the placebo effect contributes to the true treatment effect requires measurement against a control of no treatment. The accuracy of pain scores obtained by participant recall, compared to real time assessment, should be ascertained before choosing the method of pain score measurement. To enable meta‐analysis of secondary outcomes, complication rates of femoral sheath removal should be reported by treatment group using standardised definitions.

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