8/15/19 Karolynn Echols, MD Consultant Coloplast, Allergan Post-Operative Pain Evaluation Using Grant- Allergan Positive Suggestion (POPE): A Prospective Single-Blinded Randomized Control Trial on Reducing Pain and Opioids: A Pilot Study Presenter: Rikka L. Azuma Authors : Rikka L. Azuma 1 ; Krystal Hunter, MBA 2 ; Subhadra Acharya 1 ; Andrea Martin, CRNP 3 ; Karolynn Echols, MD 3 1 Sidney Kimmel Medical College, Thomas Jefferson University; 2 Cooper Medical School of Rowan University; 3 Department of Obstetrics and Gynecology, Thomas Jefferson University Hospitals What is positive suggestion? Communication: The Basis for Positive Suggestion Communication is not only the content but also the manner in It is recognizing all the ways that we communicate with our which it is conveyed. patients and utilizing those to affect the way that they perceive their experience, both consciously and • non-verbal cues, tone, attitude, body language subconsciously. Conveys our level of: • Attention, interest, certainty, commitment, support, expectation of the patient’s own role to play in their treatment Can be received by the patient on a conscious and subconscious level. 1
8/15/19 Are patients especially susceptible to How is medical treatment often suggestive? suggestion? 1. Being a patient: vulnerability, stress, fear, loss of control, • Pain has emotional, social, and cognitive aspects besides and dependency physical/sensory effects 2. Being in the medical environment: unfamiliarity and • Ex: “Are you in any pain?” suggests that the patient complexity of the people, processes, and objects should be in pain or will be in pain • Often not intended to be negative What have previous studies found on positive Why is positive suggestion a worthwhile study topic? suggestion and pain? • Meta-analyses : • Simplicity of modifications • Peerdeman et al. 2016: • Not costly • verbal suggestion on clinical pain with medium effect • Low risk to patients • Jakubovits et al. 2011: • Personalized suggestions given during anesthesia • Reduce exposure to analgesics, including opioids • Less pain on day of surgery, less pain relief required (p=0.02) on post-op • Nationwide: days 1-6 • In 2017, opioids were involved in 47,600 overdose deaths (67.8% of • Keceks et al. 2014: all drug overdose deaths) • Small reduction in pain intensity more so in acute than chronic pain • Philadelphia: 84% of the drug deaths involved opioids • Physiology : positive suggestion found to increase pain tolerance via activation of the opioid and cannabinoid systems • In a nationwide cohort of adults from 2013-2014 who had NOT • In practice : studies have documented the presence of suggestion in patient- been exposed to prescription opiates in the year prior to nurse interactions but have not targeted this for intervention. surgery, 6% had persistent prescription opioid use 90-180 days post-op. 2
8/15/19 Methods: Recruitment Participant Flow Diagram Assessed for eligibility (n= 47) • 47 patients recruited; 39 analyzed Excluded (n= 7) • Eligibility: adult patients undergoing same-day or inpatient ♦ Did not meet inclusion criteria (n= 1) ♦ Declined to participate (n= 6) gynecological or urogynecological surgery Randomized (n= 40) • Exclusion: decisionally-impaired, participating in another pain study, unable to understand spoken or written English, pregnant Allocation • Recruitment and consent obtained prior to procedure Allocated to comfort group (n= 20) Allocated to control group (n= 20) ♦ Received allocated intervention (n= 19) ♦ Received standard of care treatment (n= 20) • Baseline surveys: ♦ Did not receive allocated intervention due to cancellation of surgery (n= 1) • Catastrophizing (PCS), Anxiety (GAD-7), Depression (PHQ-9) • Random assignment to comfort group or control group Outcome Analysis Analysed (n= 19) Analysed (n= 20) Methods: Intervention Methods: Modified VAS Pain Scale On a scale Comfort Protocol Control Protocol from 0 to 10, where 0 is 1- Provider-patient discussions: 1- Provider-patient discussions: greatest Use the word descriptor “comfort” comfort, 10 is Use the word descriptor “pain” as instead of “pain” usual greatest Examples: discomfort and • Are you comfortable? 5 is moderate • Are you feeling discomfort? • How comfortable are you feeling? discomfort, • I’m sorry you’re feeling how would you uncomfortable. What can I do to rate your make you feel more comfortable? comfort? 2- Use of modified VAS Pain Scale 2- Use standard VAS Pain Scale 3
8/15/19 Outcome Measures and Hypothesis Baseline Characteristics of Sample Characteristics Comfort, Control, P n=20 n=20 value Demographics • Primary Outcome: Analgesia administered Age (years) 53 ± 13 52 ± 16 0.773 mean ± SD • Opioid dosage (in mcg of Fentanyl I.M.) Race/Ethnicity, N (%) Black or African American 7 (35) 8 (40) 0.744 • Use or non-use of any non-opioid White or Caucasian 11 (55) 11 (55) 1.000 Hispanic 3 (15) 1(5) 0.292 Surgical History 1 Includes Cesarean section, hysterectomy, Prior Abdominal Surgery 1 , N (%) 9 (45) 10 (50) 0.752 • Secondary Outcome: VAS Pain Scores over time appendectomy, diagnostic laparoscopy, gastric bypass, myomectomy, bladder surgery, salpingo- Surgery opherectomy. Classification 2 , N (%) 0.053 2 Surgery was classified as minor unless it Major 9 (45) 15 (75) included a major procedure. See Appendix Table • Hypothesis: our intervention will decrease the VAS pain for specific procedures and their classification. Minor 11 (55) 5 (25) 3 Possible depressive disorder indicated by a score Possible Pain Predictors scores and analgesia administered post operatively. of ≥ 10 on Patient Health Questionnaire-9 (PHQ9). Possible Depressive Disorder 3 , N 1 (5) 5 (25) 0.182 4 Anxiety measured with Generalized Anxiety Disorder-7 (GAD-7). Scores of 5-9 suggest mild (%) anxiety, 10 to 14 suggest moderate anxiety, 15 to Anxiety 4 , N (%) 0.212 21 suggest severe anxiety. Mild 7 (35) 5 (25) 5 Pain Catastrophizing measured as a total score Moderate 0 (0) 2 (10) ≥ 30 on the Pain Catastrophizing Scale (PCS). This Severe 0 (0) 2(10) has been shown to be clinically relevant level of catastrophizing. Pain Catastrophizing 5 , N (%) 1 (5) 5 (25) 0.182 Prior Depression or Anxiety Diagnosis, N (%) 0 (0) 3 (15) 0.231 Procedures included Results: Surgery Classification N Major PACU Analgesia Administration: Total Hysterectomy 19 Cystocele Repair 1 • Opioids: non-significant reduction, trend Enterocele Repair 1 Lefort Colpocleisis with Posterior Prolapse Repair, Bilateral Open-Ended Stent 1 • Non-opioids: significant reduction, p<0.05 Placement, and Ureteral Sling Perineorrhaphy/vaginal paravaginal repair with axis graft, bilateral 1 sacrospinous ligament Pelvic and Periaortic Lymph Node Dissection 2 Medication, n Comfort, Control, Odds Ratio (95% P Robotic Sacrocolpopexy 1 Robotic Myomectomy 1 (%) n=19 n=20 CI) value Abdominoplasty 1 Opioid 4 (21) 12 (60) 0.11 (0.01, 1.04) 0.054 Omentectomy 1 Non-opioid 12 (63) 19 (95) 5.53 (1.26, 24.2) 0.023* Minor Diagnostic Laparoscopy 6 *p value ≤ 0.05 Bilateral Salpingectomy 17 Bilateral Oopherectomy 5 Cystoscopy 13 VAS Pain perception scores: no significant change found Hysteroscopy 3 Dilatation and Curettage 3 Vaginal Laceration Repair 1 Partial Vulvectomy 1 Change Scores P value Percutaneous Nerve Stimulation Placement 1 Change between first and last recorded values: Removal of Gartner’s Duct Cyst 1 Comfort, n=19 0.813 Unilateral Oopherectomy 1 Control, n=20 0.669 Polypectomy 2 Excision of Endometriosis 1 Change Values of Comfort vs. Control Groups 1 0.792 Revision of Vaginal Graft 1 1 By Mann Whitney U Test. Bladder Biopsy 1 Vulvarplasty with Vaginoplasty and Perineoplasty 1 Coaptite Injection 1 8/15/19 4
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