Effectiveness Not Established

Stellate Ganglion Block

for Sleep-Wake Disturbances

This procedure is an injection of anesthetic into the area of the stellate ganglion for treatment of neuropathies and pain in upper extremity, thorax, face, or neck. The mechanism of action of the stellate ganglion block is not completely clear, but it is thought to work by producing peripheral vasodilation, resulting in neural inhibition in the ganglion's sphere of innervations (Lipov et al., 2008). The procedure has been studied for the management of hot flashes and sleep-wake disturbances.

Lipov, E.G., Joshi, J.R., Sanders, S., Wilcox, K., Lipov, S., Xie, H., ... Slavin, K. (2008). Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: A pilot study. Lancet Oncology, 9, 523–532. doi:10.1016/S1470-2045(08)70131-1

Research Evidence Summaries

Haest, K., Kumar, A., Van Calster, B., Leunen, K., Smeets, A., Amant, F., . . . Neven, P. (2012). Stellate ganglion block for the management of hot flashes and sleep disturbances in breast cancer survivors: an uncontrolled experimental study with 24 weeks of follow-up. Annals of Oncology, 23, 1449–1454.

Study Purpose

Researchers studied the long-term efficacy of stellate ganglion block (SGB) treatment in reducing hot flashes (HF) and improving sleep disturbances in breast cancer survivors.  

Intervention Characteristics/Basic Study Process

Female breast cancer survivors who were experiencing HF and sleep disturbances were enrolled to undergo SGB treatment. A pilot study was conducted on nine patients before the main study enrolled 25 patients for the SGB treatment. In the pilot study, patient assessments occurred at baseline (one week before SGB) and four weeks after treatment. In the main study, patients were assessed at baseline and at weeks 1, 4, 12, and 24 after treatment.

Sample Characteristics

  • The pilot study enrolled nine women, and the main study enrolled 25.
  • Median age was 53 years (range 34–69).
  • Patients were included if they
    • Were women
    • Had nonrecurrent, early stage, postmenopausal breast cancer diagnosed more than five years prior
    • Had a Karnofsky Performance Scale score (KPS) greater than 80%
    • Had severe treatment-resistant HF.
  • Patients were excluded if they had a change of antihormonal therapy for breast cancer within eight weeks of the first SGB, blood clotting disorders, use of anticoagulatants (other than low-dose aspirin), any acute infections, cardiac disorders, and an American Society of Anesthesiologists (ASA) classification score greater than three, as determined by an anesthetist.
  • Previous use of systemic therapy for climacteric symptoms was recorded, but simultaneous use of these agents was not allowed.

Setting

  • Single site   
  • Outpatient
  • University Hospital, Leuven, Belgium

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase of care after initial treatment.
  • The study has clinical applicability for late effects and survivorship.

Study Design

This was a prospective, single-arm, nonrandomized trial.

Measurement Instruments/Methods

The Climacteric Symptom Form, HF diary, and Pittsburgh Sleep Quality Index (PSQI) were used to assess the efficacy of SGB on HF and sleep quality. 

Results

This study was divided into two parts:  a pilot study of nine patients and the main study of 25 patients. All patients completed the treatment intervention (SGB) and the assessment to week 24.

  • Pilot study:  Five of nine patients had a unilateral SCB; the remaining four had the block bilaterally. Three patients reported no change in HF or sleep quality. Six reported improvement in either the severity of their HF or in sleep quality. All patients required a bilateral SGB to maintain the improvement. 
  • Main study: This study showed a decrease in the HF score of 64% (95% confidence interval [CI] [49, 74]) at week 1 and 47% at week 24 (95% CI [27, 62]). The odds ratio for improved sleep quality at week 24 compared with baseline was 4.26 (95% CI [1.86, 9.77]). Thus, SGB seemed to maintain its positive effect on sleep quality over time.

Conclusions

SGB appears to be effective in reducing the number of HF and improving sleep quality in women with early stage breast cancer who are experiencing HF and are resistant to other therapies. The HF gradually returned over time, whereas the improvement in the sleep quality was maintained over 24 weeks. The study demonstrated excellent patient compliance and noted very few side effects other than treatment-induced Horner’s syndrome (ptosis, miosis, anhidrosis, and enophthalmos) that lasted less than six hours.

Limitations

  • The study lacked an appropriate control group.
  • The study had a small sample size. The article contains both the data from the pilot study of nine patients and the main study of 25 patients.
  • Terminology used in this article was difficult to interpret, and statistical applications for results were confusing.
  • There was no consistency to performing a unilateral versus bilateral SGB or to the timing of the second SBG.

Nursing Implications

The treatment was reported to be safe and very well tolerated, and the side effects were minimal. Further investigation is warranted to identify feasibility in community practices as well as further identification of the appropriate patient population for this intervention.

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Lipov, E. G., Joshi, J. R., Sanders, S., Wilcox, K., Lipov, S., Xie, H., … Slavin, K. (2008). Effects of stellate-ganglion block on hot flushes and night awakenings in survivors of breast cancer: a pilot study. Lancet Oncology, 9, 523–532.

Study Purpose

To investigate the hypothesis that stellate ganglion block (SGB) can be a safe and effective treatment for hot flushes (HF) and sleep dysfunction in patients with breast cancer.

Intervention Characteristics/Basic Study Process

Thirteen women with breast cancer (in remission) experiencing severe HF and night awakenings were treated with SGB at the anterolateral aspect of the C6 vertebra on the right side under fluoroscopy. Patients recorded HF in a daily diary by use of the Hot Flash Score and night awakenings by use of the Pittsburgh Sleep Quality Index (PSQI). Both instruments were used one week before the procedure and then weekly after the procedure for 12 weeks. The generalized-estimating-equations method was used to analyze the longitudinal measurements of the number of HF and night awakenings over time.

Sample Characteristics

  • The sample was comprised of 13 women.
  • Age ranged from 38 to 71 years.  

Setting

  • Single site
  • Outpatient oncology clinic
  • Midwest

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase of care after initial treatment.
  • The study has clinical applicability for late effects and survivorship.

Study Design

This pilot study used a prospective, single-arm, pre/post design.

Measurement Instruments/Methods

  • Demographic and clinical information form 
  • Hot Flash Score and daily sleep diary (daily log detailing the frequency and severity of HF and sleep disturbances)
  • PSQI

Results

No adverse events resulted from the SGB, although patients had temporary Horner's syndrome, indicating the effectiveness of the block. Five patients had only one SGB, and eight had two SGBs. The total number of HF decreased from a mean of 79.4 (standard deviation [SD] = 37.4) per week before the procedure to a mean of 49.9 (SD = 39.9) per week during the first two weeks after the procedure (p = 0.0002). The total number of HF continued to decrease over the remaining follow-up period (weeks 3–12) and stabilized at a mean of 8.1 (SD = 5.6) per week (p < 0.0001). The number of very severe HF was decreased to near zero by the end of the follow-up period (week 12; p < 0.0001). Night awakenings decreased from a mean of 19.5 (SD = 14.8) per week before the procedure to a mean of 7.3 (SD = 7.1) per week during the first two weeks after the procedure (p < 0.0001). The total number of night awakenings continued to decrease over the remaining follow-up period (weeks 3–12) and stabilized at a mean of 1.4 (SD = 1.2) per week (p < 0.0001).

Conclusions

The findings suggest that SGB can provide survivors of breast cancer with relief from HF and sleep dysfunction, with few or no side effects. Long-term symptom relief has the potential to improve overall quality of life (QOL) and increase compliance with antiestrogen medications for breast cancer.

Limitations

  • The study lacked an appropriate control group.
  • The study had a small sample size.
  • The majority of patients required repeat block procedures.

Nursing Implications

The findings suggest that SGB can provide breast cancer survivors with relief from HF and sleep disturbances, with potential to improve overall QOL.

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