8/15/19 Karolynn Echols, MD Consultant Coloplast, Allergan - - PDF document

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Post-Operative Pain Evaluation Using 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. Azuma1; Krystal Hunter, MBA2; Subhadra Acharya1; Andrea Martin, CRNP3; Karolynn Echols, MD3

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

Karolynn Echols, MD Consultant Coloplast, Allergan Grant- Allergan

Communication is not only the content but also the manner in which it is conveyed.

• non-verbal cues, tone, attitude, body language

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.

Communication: The Basis for Positive Suggestion What is positive suggestion?

It is recognizing all the ways that we communicate with our patients and utilizing those to affect the way that they perceive their experience, both consciously and subconsciously.

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Are patients especially susceptible to suggestion?

• 1. Being a patient: vulnerability, stress, fear, loss of control,

and dependency

• 2. Being in the medical environment: unfamiliarity and

complexity of the people, processes, and objects

How is medical treatment often suggestive?

• Pain has emotional, social, and cognitive aspects besides

physical/sensory effects

• Ex: “Are you in any pain?” suggests that the patient

should be in pain or will be in pain

• Often not intended to be negative

What have previous studies found on positive suggestion and pain?

• Meta-analyses:
• Peerdeman et al. 2016:
• verbal suggestion on clinical pain with medium effect
• Jakubovits et al. 2011:
• Personalized suggestions given during anesthesia
• Less pain on day of surgery, less pain relief required (p=0.02) on post-op

days 1-6

• Keceks et al. 2014:
• Small reduction in pain intensity more so in acute than chronic pain
• Physiology: positive suggestion found to increase pain tolerance via activation
• f the opioid and cannabinoid systems
• In practice: studies have documented the presence of suggestion in patient-

nurse interactions but have not targeted this for intervention.

Why is positive suggestion a worthwhile study topic?

• Simplicity of modifications
• Not costly
• Low risk to patients
• Reduce exposure to analgesics, including opioids
• Nationwide:
• In 2017, opioids were involved in 47,600 overdose deaths (67.8% of

all drug overdose deaths)

• Philadelphia: 84% of the drug deaths involved opioids
• In a nationwide cohort of adults from 2013-2014 who had NOT

been exposed to prescription opiates in the year prior to surgery, 6% had persistent prescription opioid use 90-180 days post-op.

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Methods: Recruitment

• 47 patients recruited; 39 analyzed
• Eligibility: adult patients undergoing same-day or inpatient

gynecological or urogynecological surgery

• Exclusion: decisionally-impaired, participating in another

pain study, unable to understand spoken or written English, pregnant

• Recruitment and consent obtained prior to procedure
• Baseline surveys:
• Catastrophizing (PCS), Anxiety (GAD-7), Depression (PHQ-9)
• Random assignment to comfort group or control group

Excluded (n= 7)

♦ Did not meet inclusion criteria (n= 1) ♦ Declined to participate (n= 6)

Analysed (n= 19) Allocated to comfort group (n= 20)

♦ Received allocated intervention (n= 19) ♦ Did not receive allocated intervention due to

cancellation of surgery (n= 1) Allocated to control group (n= 20)

♦ Received standard of care treatment (n= 20)

Assessed for eligibility (n= 47) Analysed (n= 20)

Allocation Outcome Analysis

Randomized (n= 40)

Participant Flow Diagram Methods: Intervention

Comfort Protocol

1- Provider-patient discussions:

Use the word descriptor “comfort” instead of “pain” Examples:

• Are you comfortable?
• Are you feeling discomfort?
• How comfortable are you feeling?
• I’m sorry you’re feeling
• uncomfortable. What can I do to

make you feel more comfortable?

2- Use of modified VAS Pain Scale

Control Protocol

1- Provider-patient discussions:

Use the word descriptor “pain” as usual

2- Use standard VAS Pain Scale

Methods: Modified VAS Pain Scale

On a scale from 0 to 10, where 0 is greatest comfort, 10 is greatest discomfort and 5 is moderate discomfort, how would you rate your comfort?

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Outcome Measures and Hypothesis

• Primary Outcome: Analgesia administered
• Opioid dosage (in mcg of Fentanyl I.M.)
• Use or non-use of any non-opioid
• Secondary Outcome: VAS Pain Scores over time
• Hypothesis: our intervention will decrease the VAS pain

scores and analgesia administered post operatively.

Baseline Characteristics of Sample

Characteristics Comfort, n=20 Control, n=20 P value Demographics Age (years) mean ± SD 53 ± 13 52 ± 16 0.773 Race/Ethnicity, N (%) Black or African American White or Caucasian Hispanic 7 (35) 11 (55) 3 (15) 8 (40) 11 (55) 1(5) 0.744 1.000 0.292 Surgical History Prior Abdominal Surgery1, N (%) 9 (45) 10 (50) 0.752 Surgery Classification2, N (%) Major Minor 9 (45) 11 (55) 15 (75) 5 (25) 0.053 Possible Pain Predictors Possible Depressive Disorder3, N (%) 1 (5) 5 (25) 0.182 Anxiety4, N (%) Mild Moderate Severe 7 (35) 0 (0) 0 (0) 5 (25) 2 (10) 2(10) 0.212 Pain Catastrophizing5, N (%) 1 (5) 5 (25) 0.182 Prior Depression or Anxiety Diagnosis, N (%) 0 (0) 3 (15) 0.231

1 Includes Cesarean section, hysterectomy,

appendectomy, diagnostic laparoscopy, gastric bypass, myomectomy, bladder surgery, salpingo-

• pherectomy.

2 Surgery was classified as minor unless it

included a major procedure. See Appendix Table for specific procedures and their classification.

3 Possible depressive disorder indicated by a score

• f ≥10 on Patient Health Questionnaire-9 (PHQ9).

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 21 suggest severe anxiety.

5 Pain Catastrophizing measured as a total score

≥30 on the Pain Catastrophizing Scale (PCS). This has been shown to be clinically relevant level of catastrophizing.

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Surgery Classification N Major Total Hysterectomy 19 Cystocele Repair 1 Enterocele Repair 1 Lefort Colpocleisis with Posterior Prolapse Repair, Bilateral Open-Ended Stent Placement, and Ureteral Sling 1 Perineorrhaphy/vaginal paravaginal repair with axis graft, bilateral sacrospinous ligament 1 Pelvic and Periaortic Lymph Node Dissection 2 Robotic Sacrocolpopexy 1 Robotic Myomectomy 1 Abdominoplasty 1 Omentectomy 1 Minor Diagnostic Laparoscopy 6 Bilateral Salpingectomy 17 Bilateral Oopherectomy 5 Cystoscopy 13 Hysteroscopy 3 Dilatation and Curettage 3 Vaginal Laceration Repair 1 Partial Vulvectomy 1 Percutaneous Nerve Stimulation Placement 1 Removal of Gartner’s Duct Cyst 1 Unilateral Oopherectomy 1 Polypectomy 2 Excision of Endometriosis 1 Revision of Vaginal Graft 1 Bladder Biopsy 1 Vulvarplasty with Vaginoplasty and Perineoplasty 1 Coaptite Injection 1

Procedures included Results:

Change Scores P value Change between first and last recorded values: Comfort, n=19 Control, n=20 0.813 0.669 Change Values of Comfort vs. Control Groups1 0.792 Medication, n (%) Comfort, n=19 Control, n=20 Odds Ratio (95% CI) P value Opioid 4 (21) 12 (60) 0.11 (0.01, 1.04) 0.054 Non-opioid 12 (63) 19 (95) 5.53 (1.26, 24.2) 0.023*

1 By Mann Whitney U Test.

*p value ≤0.05

VAS Pain perception scores: no significant change found PACU Analgesia Administration:

• Opioids: non-significant reduction, trend
• Non-opioids: significant reduction, p<0.05

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• Single-blinding:
• The belief of nurses carrying out our protocol may have

affected the way the protocol was delivered.

• Lack of protocol monitoring:
• We were unable to monitor the nurses’ performance of the

protocol.

• Small sample size:
• We hypothesize this may be obscuring a significant reduction in opioid

administration and VAS pain scores.

Limitations

• The goal is effective pain management in which benefit
• utweighs harm.
• The Enhanced Recovery After Surgery (ERAS) Society
• supports minimizing the use of opioids
• recognizes the psycho-social effects of well-being and pain on

surgical outcomes

• Our study offers necessary elucidation of how these concepts can

be put into practice.

• Applicable to other surgical fields and to hospital floors for

extended post op care

• Many studies focus on other phases of surgery; thus, our

intervention's position in immediate postoperative care offers novel insight.

Discussion References:

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Thank you for your attention!

Acknowledgements:

• Our subjects and their families
• Faculty and Staff of Department of Obstetrics and Gynecology,

Thomas Jefferson University Hospital. Especially the nurses of SPU, 5th, and 7th floor PACUs; Drs. Rosenblum, Richard, Kim, Teefey, Murphy; Ms. Sendek; Dr. Braverman; Ms. Brooks

• Drs. Plumb and Brawer and the CwiC Population Health

Program; Dr. Daskalakis and the Dean’s Summer Research Program; all part of SKMC at TJU.

• AUGS/IUGA for this opportunity to present our research