CLINICAL INVESTIGATION
The Efficacy of P6 Acupressure With Sea-Band in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: A Randomized, Double-blinded, Placebo-controlled Study Ida Nilsson, CCRN, MSc,*w A˚sa Karlsson, CCRN, MSc,*w Lenita Lindgren, CCRN, MSc, PhD,z Tommy Bergenheim, MD, PhD,y Lars-Owe Koskinen, MD, PhD,y and Ulrica Nilsson, RNA, PhD8
Background: Postoperative nausea and vomiting (PONV) is a multifactorial problem after general anesthesia. Despite antiemetic prophylaxis and improved anesthetic techniques, PONV still occurs frequently after craniotomies. P6 stimulation is described as an alternative method for preventing PONV. The primary aim of this study was to determine whether P6 acupressure with Sea-Band could reduce postoperative nausea after elective craniotomy. Secondary aims were to investigate whether the frequency of vomiting and the need for antiemetics could be reduced. Methods: In this randomized, double-blinded, placebo-controlled study, patients were randomized into either a P6 acupressure group (n = 43) or a sham group (n = 52). Bands were applied unilaterally at the end of surgery, and all patients were administered prophylactic ondansetron. Postoperative nausea was evaluated with a Numerical Rating Scale, 0 to10, and the frequency of vomiting was recorded for 48 hours. Results: We found no significant effect from P6 acupressure with Sea-Band on postoperative nausea or vomiting in patients undergoing craniotomy. Nor was there any difference in the need for rescue antiemetics. Altogether, 67% experienced PONV, and this was especially an issue at >24 hours in patients recovering from infratentorial surgery compared with supratentorial surgery (55% vs. 26%; P = 0.014).
Received for publication January 22, 2014; accepted May 28, 2014. From the Departments of *Neurosurgery; wNursing; yClinical Neuroscience, Neurosurgery, Umea˚ University; zUmea˚ Functional Brain Imaging (UFBI), Umea˚; and 8School of Health and Medical Sciences, O¨rebro University, O¨rebro, Sweden. I.N. and A˚.K. contributed equally. P6 acupressure bands and sham bands were partly provided by SeaBand Ltd, Hinckley, Leicestershire, UK. The rest of the bands and the study material were provided by the Department of Neurosurgery of Umea˚ University Hospital. The study was supported by the hospitals research foundation. The authors have no conflicts of interest to disclose. Reprints: Ida Nilsson, CCRN, MSc, Department of Neurosurgery, Umea˚ University Hospital, 901 85 Umea˚, Sweden (e-mail: akar0002@ student.umu.se). Copyright r 2014 by Lippincott Williams & Wilkins
42 | www.jnsa.com
Conclusions: Unilateral P6 acupressure with Sea-Band applied at the end of surgery together with prophylactic ondansetron did not significantly reduce PONV or the need for rescue antiemetics in patients undergoing craniotomy. Our study confirmed that PONV is a common issue after craniotomy, especially after infratentorial surgery. Key Words: postoperative nausea and vomiting, P6 acupressure, craniotomy (J Neurosurg Anesthesiol 2015;27:42–50)
P
ostoperative nausea and vomiting (PONV) is the most frequent complication in patients undergoing general anesthesia,1 referred to as “the big little problem.”2,3 PONV is often regarded by patients as the single most stressful effect of anesthesia,4 rated as even more distressing than postoperative pain.5 Despite modern antiemetics5 and specific anesthetics, PONV still occurs in 20% to 30% of the general surgical population.6 After neurosurgical procedures with craniotomy, the incidence of PONV is 47% to 73%.7–9 For neurosurgical patients, vomiting can cause a rapid increase in arterial and intracranial pressure that negatively affects hemostasis and cerebral perfusion.7,10 Intracranial surgery itself can influence PONV by direct pressure or manipulation of the vomiting center.9,11 This might lead to fatal consequences such as intracranial hemorrhage and neurological dysfunction.7,12 Antiemetics for these patients should desirably not be sedating to allow postoperative neurological assessment.8 Therefore, the use of muscarinic, histamine, and dopamine receptor antagonists might be limited because of their sedative side effects.13 When modern antiemetics, optimized anesthetic techniques, and drugs are not sufficient for eliminating PONV, alternative methods for prophylaxis have become more common and accepted.14 Acupressure and acupuncture have been used for >2500 years in traditional Chinese medicine as prophylaxis for nausea and vomiting. The P6 “Neiguan” acupoint—located about 3 cm proximal to the distal wrist between the tendons of the flexor J Neurosurg Anesthesiol
Volume 27, Number 1, January 2015
J Neurosurg Anesthesiol
Volume 27, Number 1, January 2015
carpi radialis and the palmaris longus15—is described as the most important and also the most investigated acupoint for prevention of PONV.14,15 According to Lee and Fan,16 and Ezzo et al,17 the effect of P6 stimulation was similar for both invasive (acupuncture) or noninvasive stimulation methods. Nunley et al18 have concluded that all types of noninvasive stimulation of P6 are effective for prevention of PONV, including electrostimulation; acustimulation with Reliefband, Sea-Band, and Acuband; and plain acupressure. Although noninvasive P6 stimulation is claimed to significantly reduce PONV,1,16,19–29 there are conflicting and different results regarding its efficacy.30–33 There is also disagreement of when to administer the stimulation,1,23–26,30–32 how long the effect lasts,1,19,21,25,34 and whether the use of unilateral stimulation is as good as bilateral stimulation.18,23,24,26,30,32 Some studies suggest that the more risk factors for PONV, the better the postoperative effect of P6 stimulation.1,25,35 There are also results suggesting that P6 stimulation is an effective adjunct to standard antiemetic drug therapy for preventing PONV.4,23,24 Research on the efficacy of P6 stimulation and PONV in patients undergoing craniotomy is sparse. However, there are 2 investigations that showed a significant reduction in the prevalence of PONV when using electrostimulation.26,27 Sea-Band is one of the most popular and easy-to-use methods for noninvasive P6 stimulation.15 We therefore wanted to investigate whether P6 acupressure with Sea-Band would also provide efficacy for these patients. The primary aim of this study was to determine whether P6 acupressure with Sea-Band could reduce postoperative nausea (PON) after craniotomy. Secondary aims were to investigate whether the frequency of vomiting and the need of antiemetics could also be reduced.
PATIENTS AND METHODS The study design was randomized, double blinded, and placebo controlled. A total of 120 patients, scheduled to undergo craniotomy at the Department of Neurosurgery of Umea˚ University Hospital from November 2011 to June 2013, were randomly assigned to either the P6 acupressure group or the sham group using a computer-generated random number table. Inclusion criteria were elective infratentorial or supratentorial craniotomy, and age 18 years and above. Patients not able to actively participate in the study because of their mental status or communication problems, and patients who had received antiemetics
The Efficacy of P6 Acupressure With Sea-Band in Reducing Postoperative Nausea and Vomiting in Patients Undergoing Craniotomy: A Randomized, Double-blinded, Placebo-controlled Study Ida Nilsson, CCRN, MSc,*w A˚sa Karlsson, CCRN, MSc,*w Lenita Lindgren, CCRN, MSc, PhD,z Tommy Bergenheim, MD, PhD,y Lars-Owe Koskinen, MD, PhD,y and Ulrica Nilsson, RNA, PhD8
Background: Postoperative nausea and vomiting (PONV) is a multifactorial problem after general anesthesia. Despite antiemetic prophylaxis and improved anesthetic techniques, PONV still occurs frequently after craniotomies. P6 stimulation is described as an alternative method for preventing PONV. The primary aim of this study was to determine whether P6 acupressure with Sea-Band could reduce postoperative nausea after elective craniotomy. Secondary aims were to investigate whether the frequency of vomiting and the need for antiemetics could be reduced. Methods: In this randomized, double-blinded, placebo-controlled study, patients were randomized into either a P6 acupressure group (n = 43) or a sham group (n = 52). Bands were applied unilaterally at the end of surgery, and all patients were administered prophylactic ondansetron. Postoperative nausea was evaluated with a Numerical Rating Scale, 0 to10, and the frequency of vomiting was recorded for 48 hours. Results: We found no significant effect from P6 acupressure with Sea-Band on postoperative nausea or vomiting in patients undergoing craniotomy. Nor was there any difference in the need for rescue antiemetics. Altogether, 67% experienced PONV, and this was especially an issue at >24 hours in patients recovering from infratentorial surgery compared with supratentorial surgery (55% vs. 26%; P = 0.014).
Received for publication January 22, 2014; accepted May 28, 2014. From the Departments of *Neurosurgery; wNursing; yClinical Neuroscience, Neurosurgery, Umea˚ University; zUmea˚ Functional Brain Imaging (UFBI), Umea˚; and 8School of Health and Medical Sciences, O¨rebro University, O¨rebro, Sweden. I.N. and A˚.K. contributed equally. P6 acupressure bands and sham bands were partly provided by SeaBand Ltd, Hinckley, Leicestershire, UK. The rest of the bands and the study material were provided by the Department of Neurosurgery of Umea˚ University Hospital. The study was supported by the hospitals research foundation. The authors have no conflicts of interest to disclose. Reprints: Ida Nilsson, CCRN, MSc, Department of Neurosurgery, Umea˚ University Hospital, 901 85 Umea˚, Sweden (e-mail: akar0002@ student.umu.se). Copyright r 2014 by Lippincott Williams & Wilkins
42 | www.jnsa.com
Conclusions: Unilateral P6 acupressure with Sea-Band applied at the end of surgery together with prophylactic ondansetron did not significantly reduce PONV or the need for rescue antiemetics in patients undergoing craniotomy. Our study confirmed that PONV is a common issue after craniotomy, especially after infratentorial surgery. Key Words: postoperative nausea and vomiting, P6 acupressure, craniotomy (J Neurosurg Anesthesiol 2015;27:42–50)
P
ostoperative nausea and vomiting (PONV) is the most frequent complication in patients undergoing general anesthesia,1 referred to as “the big little problem.”2,3 PONV is often regarded by patients as the single most stressful effect of anesthesia,4 rated as even more distressing than postoperative pain.5 Despite modern antiemetics5 and specific anesthetics, PONV still occurs in 20% to 30% of the general surgical population.6 After neurosurgical procedures with craniotomy, the incidence of PONV is 47% to 73%.7–9 For neurosurgical patients, vomiting can cause a rapid increase in arterial and intracranial pressure that negatively affects hemostasis and cerebral perfusion.7,10 Intracranial surgery itself can influence PONV by direct pressure or manipulation of the vomiting center.9,11 This might lead to fatal consequences such as intracranial hemorrhage and neurological dysfunction.7,12 Antiemetics for these patients should desirably not be sedating to allow postoperative neurological assessment.8 Therefore, the use of muscarinic, histamine, and dopamine receptor antagonists might be limited because of their sedative side effects.13 When modern antiemetics, optimized anesthetic techniques, and drugs are not sufficient for eliminating PONV, alternative methods for prophylaxis have become more common and accepted.14 Acupressure and acupuncture have been used for >2500 years in traditional Chinese medicine as prophylaxis for nausea and vomiting. The P6 “Neiguan” acupoint—located about 3 cm proximal to the distal wrist between the tendons of the flexor J Neurosurg Anesthesiol
Volume 27, Number 1, January 2015
J Neurosurg Anesthesiol
Volume 27, Number 1, January 2015
carpi radialis and the palmaris longus15—is described as the most important and also the most investigated acupoint for prevention of PONV.14,15 According to Lee and Fan,16 and Ezzo et al,17 the effect of P6 stimulation was similar for both invasive (acupuncture) or noninvasive stimulation methods. Nunley et al18 have concluded that all types of noninvasive stimulation of P6 are effective for prevention of PONV, including electrostimulation; acustimulation with Reliefband, Sea-Band, and Acuband; and plain acupressure. Although noninvasive P6 stimulation is claimed to significantly reduce PONV,1,16,19–29 there are conflicting and different results regarding its efficacy.30–33 There is also disagreement of when to administer the stimulation,1,23–26,30–32 how long the effect lasts,1,19,21,25,34 and whether the use of unilateral stimulation is as good as bilateral stimulation.18,23,24,26,30,32 Some studies suggest that the more risk factors for PONV, the better the postoperative effect of P6 stimulation.1,25,35 There are also results suggesting that P6 stimulation is an effective adjunct to standard antiemetic drug therapy for preventing PONV.4,23,24 Research on the efficacy of P6 stimulation and PONV in patients undergoing craniotomy is sparse. However, there are 2 investigations that showed a significant reduction in the prevalence of PONV when using electrostimulation.26,27 Sea-Band is one of the most popular and easy-to-use methods for noninvasive P6 stimulation.15 We therefore wanted to investigate whether P6 acupressure with Sea-Band would also provide efficacy for these patients. The primary aim of this study was to determine whether P6 acupressure with Sea-Band could reduce postoperative nausea (PON) after craniotomy. Secondary aims were to investigate whether the frequency of vomiting and the need of antiemetics could also be reduced.
PATIENTS AND METHODS The study design was randomized, double blinded, and placebo controlled. A total of 120 patients, scheduled to undergo craniotomy at the Department of Neurosurgery of Umea˚ University Hospital from November 2011 to June 2013, were randomly assigned to either the P6 acupressure group or the sham group using a computer-generated random number table. Inclusion criteria were elective infratentorial or supratentorial craniotomy, and age 18 years and above. Patients not able to actively participate in the study because of their mental status or communication problems, and patients who had received antiemetics
