Pain with Office Gyn Procedures: Disclosures Tips, Tricks and Evidence

Dr. Meckstroth receives an honorarium from Danco, Inc. to serve as an expert for an FDA‐ mandated hotline for clinicians with questions regarding medical abortion.

Karen R. Meckstroth, MD, MPH Director, UCSF Women’s Options Center Clinical Professor, UCSF Dept. of Obstetrics, Gynecology & Reproductive Sciences Zuckerberg San Francisco General

Overview Components of Pain • Pain and comfort in general • Local anesthetic Attention Cognitive‐evaluation component Thought concerning the cause and Past • Uterine procedures Meaning of significance of the pain experience situation – IUD insertion (Now there are 5!) – Endometrial biopsy Anxiety – Manual uterine aspiration Motivation‐affective Fear component Depression • Quick tips for simple procedures: – Cervical polyp removal, vulvar biopsy, IUD removal, Quality colposcopy and biopsy Sensory‐discriminative Location • Not today: hysteroscopy, saline sono, LEEP, cryo Intensity component

AMA Pathophysiology of Pain 2005, Melzack Acta Anesth Scand 1999 The Peak‐End Rule Cultural Differences and Pain • People judge an experience largely based on how • Cultural differences exist in the understanding and they felt at its peak (most intense point) and its end, report of pain not on the sum or average • Unfair and unhelpful to make assumptions • “Duration neglect” ‐ judgment of unpleasantness of • painful experiences depends little on the duration Multiple studies document inferior treatment of acute (ED) and postoperative pain in U.S. minorities

Fredrickson and Kahneman 1993 and many after Anderson et al. Racial and Ethnic Disparities in Pain: Causes and Consequences of Unequal Care. J. Pain 2009

Clinician characteristics and acute pain Measuring Pain • Physician non-white race associated with No objective pain indicator significantly better pain treatment in ED1 • Satisfaction • Provider gender as opposed to patient gender • Recommend to a friend was a factor: • Choose again – Female physicians more likely to • % with severe pain (often 7‐10/10) administer analgesics than male physicians (66% vs 57%, P = 0.009)2 • McGill pain questionnaire • Pain scales – Verbal 0‐10, 0‐100; Visual Analog Scales – Clinically significant difference? 1.5 – 2 /10

1. Heins J. Pain 2010; 2. Safdar Pain Medicine 2009 Pain Descriptors and Factors Associated with Discomfort Experimental Cervical Dilation with Routine Pelvic Exams • Mean pain 3.2/10 • 17% had pain of 6‐10/10 with pelvic exam • 30% of those with a history of sexual abuse • Factors associated with high pain: Age < 26 (OR=2.75) Presence of one or more mental health problems (OR=1.9) History of sexual abuse (OR=1.85) Dissatisfaction with present sexual life (OR=1.7) Negative emotional contact with the examiner (OR=8.2)

Bajaj. Pain 2002, Arendt Eu J Pain 2004 Adjusted odds ratios, Hilden et al., Acta Ob G Scand. 2003

Minimizing Pain with a Speculum: 201 • Ask if they are ready! • Gel lubrication significantly decreases pain1 Creating rapport is pain control. • Use the right size (shortest possible for uterine procedures, open angle for large buttocks) • Avoid scraping sensitive anterior wall (don’t start at 90 degrees then rotate) • Don’t open more than needed. • Avoid “popping” the cervix into view or snapping it at time of speculum removal • Move slowly

Gungorduk K et al. Eur J ObG and Repro Bio 2015 Language Language considerations… Instead of: Try: “Most patients are worried about • “Relax” “try taking a deep breath” pain, and they are often surprised when it is easier than they had Blending “It’s a natural reaction to lift expected. As we proceed, let us up. See if you can let your compassion, hips be heavy on the table.” know how you are feeling so that medical fact, and we can make adjustments. We want this to go well for you.” positive suggestion • You might feel “a pinch” “You might feel a or ”a stick and a burn” sensation” “a twinge”

“I can see you’ve had • “You’re doing great” practice with relaxation.”

Trauma‐Informed Care for ALL Strategies for Acute Pain

Patient in • Knock before entering • Ask before doing anything (esp. touching) Multimodal pain Preemptive Control • Discuss the signal to pause management analgesia • Meet patient when clothed More than 1 class of meds or Intervention more effective Establish Trust • Ask about preferences, concerns, interests analgesic technique PRIOR to tissue injury • Partner/friend present local anesthetic + NSAID + Increased pain response to Calm, Respectful • Keep patient’s body covered narcotic + benzodiazepine + subsequent stimulation Atmosphere • Language, avoid interruptions, room temp nonpharmacologic (“wind‐up” or strategies “hyperanalgesia”) • Move & speak slowly, esp. during exam Low Stimulation • Consider topical anesthetic, avoid noise

Good resource: https://hiveonline.org/wp- Crews. JAMA 2002 content/uploads/2016/06/Landau-Breakout-Beyond-Compassion.pdf Abortion Anesthesia: Levels of Sedation What Women Choose

Minimal Sedation Moderate Deep (anxiolysis) Sedation Sedation Given the choice of 40% Example  Oral lorazepam Fentanyl 50‐100 Add propofol general vs. local ONLY Local and/or hydrocodone mg + midazolam 1‐ 3 mg IV Ambulatory 60% Nearly all women Responsiveness Normal response to Purposeful Purposeful Avoid side effects General verbal stimulation response to response after would prefer no pain verbal or tactile repeated or painful Feel awake No pain stimulation stimulation (whether awake or Airway Unaffected No intervention Intervention may asleep) though other Less anxiety 2 required be required preferences vary Spontaneous ventilation Unaffected Adequate May be inadequate Cardiovascular function Unaffected Usually maintained Usually maintained

Patient reaction defines level of sedation, not medication dose 1.Clark et al. Contraception 2002 2.Allen et al. Contraception 2012

LOCAL ANESTHESIA Nonpharmacologic pain management Other specialties expect it Patient control: to work. Participation in decisions1 They aim to block all the Counseling techniques Diversion of attention nerves they will irritate and Positive suggestion, “Vocal local” use as much as needed Guided imagery Visual distraction within safety range Hypnosis6 Ceiling art3 “I would never do a block and not test it to be sure Heat2 Music4a 5 it worked.” Acupuncture (but not pt choice –Dentist to me, 2003 TENS, TEAS by headphones4b)

2. Atkin ObGyn 2001; 3. Carwile, JLGTD 2014; 4.Cepeda.Cochrane Review 2006 4b. Guerrero Contrac 2012; 5.Kotani Anesth 2001; 6. Famonville. Pain 1997 Cervical & Uterine Nerves Variables in LA effect

Uterine fundus • Agent Sympathetic nerves via: • Dose • infundibulopelvic pelvic ligament Bottom Line: • Volume and concentration  utero‐ovarian ligament • Distance to nerves • inf hypogastric nerve through TEST for analgesia • Size/type of nerves before beginning uterosacral ligaments T10 ‐ L1 • Tissue perfusion (vasodilation) procedure and add Lower uterus/cervix more if safe to do • Temperature of injection • Parasympathetic Frankenhauser • pH of injection plexus lateral to cervix, S2 ‐ S4 • Depth of injection Sensory nerves! • Rate of injection

Tingaker. Repro bio & endoc 2006

Maximum Dosing Lidocaine Toxicity & Side Effects

Local Anesthetic Onset Max Dose (mg/kg) Max Dose (mg) 55kg pt dose (mins) without/with epi without/with epi without/with

Lidocaine 4‐7 4.5/7 mg/kg 300/500 mg 25/38 mL Bupivacaine 10‐20 2.5 mg/kg 175 mg 55 mL Chloroprocaine fast 11/14 mg/kg 800/1000 mg 60/77 mL

• Rough estimates that are not evidence‐based. • Lower peak levels and slower absorption with vasoconstrictor • Bupivacaine with less difference since med is vasoconstrictive

Carin MA et al. Neoreviews, 2008 Prevent Local Anesthetic Systemic Toxicity (LAST) “Paracervical Block”

 Aspirate for blood prior to injection  Monitor total dose  Monitor patient symptoms; Stop after partial dose to check symptoms Hybrid  Use larger volume of more dilute solution  Inject multiple sites/depths Want tissue distension  Prepare for toxic and allergic reactions in dense cervical stroma Deep injection rather than areolar more painful but Treatment: 100 mL 20% intralipid IV paracervical tissue more effective

Standard 20 mL block is not enough. Local Anesthetic can HURT Can we do better? • Most painful part of procedure sometimes • Deep blocks hurt more Larger dose Add MORE if pt feels any pain with dilation. Consider after uterine involution. • Minimize pain with block: ✅ Topical anesthetic first or if pain with injection Minimize block Buffer. Inject ahead of the needle. ✅ Buffered lidocaine (2mL in 200 mg lidocaine) pain Small gauge. Topical gel or spray. ✅ Small gauge needle (25G) ✅ Slow injection Aim for all Inject at internal os, uterosacral, fundus if ✅ Next injection in anesthetized area nerves possible ✅ Inject ahead of needle Wait for it to RCT’s without difference. Obs studies, ✅ Distraction (tap leg) work pharmacokinetics & neurobiology say WAIT

1 Wiebe Am J Ob Gyn, 1992, 2. Stubblefielf. Int J Gynecol Obstet 1989, 3. Wiebe Int J Gyn Obstet 1. Cochrane review 2010; 2. Saxena Contracep 2003, Guney Int J Ob Gyn 2007; 3.Waddell J 1995, 4. Wiebe Am J Ob Gyn, 1992, 5. Phair Am J Ob Gyn, 2002, 6. Wiebe Contraception. 2003 Min Inv Gyn 2008; 4. Cochrane review 2015, 5. Ireland Ob Gyn Surv 2016 Topical cervical anesthesia Intrauterine anesthesia

Cervical procedures 20% gel improved pain with: • 5mL 2% lidocaine • Cervical biopsy • 14 to 18 gauge angiocath • Paracervical block (NOT with ECC) • Tenaculum placement • Advance through cervix, SLOW infusion into cavity • Hold syringe at cervix for 2 minutes Intrauterine procedures • Aspiration: 2 sprays 10% lidocaine + 8 mL PCB improved pain 6.6  2.4/10.2 • Can combine with paracervical block • EMB: 4 sprays reduced pain 5.1  3.5/10 3 • IUD: 4 sprays reduced pain 3.2  1.0/10 (parous women)4 Mostly negative evidence for gel 1,5,6 1. Rabin ObGyn 1989 2. Karasahin Contracep 2011 3. Aksoy J Ob Gyn 2015; 4. Aksoy. FP & Repro HC 2014; 5.Maguire Contrac 2012; 6.Allen Contrac 2015

INTRAUTERINE PROCEDURES Intrauterine Local Anesthesia WHICH DO YOU DO? EMB • Uterine aspiration Lost IUD Significant improvement1,3 Removal 5mL of 2% lidocaine •EMB Saline Sono • Saline sono • IUD insertion Significant improvement MUA 5mL of 4% lidocaine2 • Hysteroscopy

HSC Mixed evidence.4-6++

Sys Rev Mercier ObGyn 2012; 1. Guney 2006; 2. Edelman 2006; 3. Guney J Min Inv gyn 2007; 4. Frishman ObGyn 2004, Costello Fert Steril 2002. Isley Contr 2012 PAIN WITH INTRAUTERINE PROCEDURES Mean Pain / 10 Misoprostol before intrauterine procedures

Uterine Aspiration 5‐7 Proc pain may improve but significant MVA side effects and pain before.1,5 EMB 4‐7 HSC Improved pain but ONLY with scopes > Saline Sono 2‐5 6mm3,5

IUD insertion 3‐7 Some with improvement, most with no EMB difference and increased cramping 2.5 Hysteroscopy 5‐7 Most studies show it does NOT help. IUC Increases pre‐procedure pain4,5

1. Cochrane review 2010; 2. Saxena Contracep 2003, Guney Int J Ob Gyn 2007; 3.Waddell J Min Inv Gyn 2008; 4. Cochrane review 2015, 5. Ireland Ob Gyn Surv 2016

Do you give NSAIDs prior to uterine NSAIDs for Uterine Procedures procedures?

• Clearly effective for dysmenorrhea and uterine aspiration • Usually • Little difference in efficacy between NSAID types in • Sometimes population, but large inter-individual difference • Rarely • Mixed evidence, but biologically plausible + safe + • I don’t do uterine procedures, but would recommend validation of need for pain control • • Ibuprofen has min effect on platelet aggregation, but I don’t do uterine procedures, wouldn’t recommend naproxen, tramadol or ketorolac may be better? except where evidence is clear

• Studies show modest reduction in intra- & post- uterine procedure pain

Ireland, Allen. Ob & Gyn Sur 2016; AMA Pathophys of Pain 2005 NSAID for IUD insertion IUD Types In Nuliparas: Copper Liletta Mirena Kyleena Skyla Hormone none LNG LNG LNG LNG Dose ‐ 52 mg 52 mg 19.5 mg 13.5 mg Release ‐ 20 20 17.5 14 mcg/d 10 at 5 yrs 10 at 5 yrs 7.4 at 5 yrs 5 at 3 yrs Years of 10‐12 5‐7 5‐7 53 use (FDA 10) (FDA 5) (FDA 5) Special Non‐ Generic Low Smaller, little Smaller, v. In Multiparas: issues hormonal, Mirena, systemic, lower dose, low dose, Tramadol 50mg Naproxen 550mg Placebo heavier non‐profit 90% less less no ovarian 2.3/10 > 2.9/10 > 4.9/10 bleeding company bleeding amenorrhea change

Ngo et al. ObGyn 2015

IUD Insertion Steps Preparation Tenaculum Placement Bimanual Inject here Speculum • If you place it, you’ll likely USE it Aneseptic • More stretch receptors than pinpoint 1 Tenaculum PAIN • Most effective: Intracervical injection 2 3 Sounding • Also helpful: Forced cough Spray or gel Insertion • I use 3‐5 mL with 25G needle and think no one should Cut strings EVER feel a tenaculum placed. Remove inst. • 1‐2 mm deep (superficial!) and inject slowly Post‐procedure

1. Naki Ob Gyn Invest 2011 & Allen 2013; 2. Bogani Eur J Ob G 2014; 2. Gooldhwaite Contrac 2014; 3. Rabin 1989; Davies 1997; Costello 2005 Block vs. No Block (20 mL 1% lido) Block vs. No Block (20 mL 1% lido) Pain with IUD insertion, nulliparas Pain with IUD insertion, nulliparas Median Pain Scores for All Time Points Median Pain Scores for All Time Points 70 70 60 60 50 * * 50 * * 40 40 * Prior study by Mody of 10 mL block 30 30 20 20 noted pain with insertion 62  24 /100 10 10 0 0 (not significant)

No PCB PCB No PCB PCB

Mody et al. ObGyn 2018 Mody et al. ObGyn 2018; Mody. Contrac 2012

Intrauterine Lidocaine for EMB Endometrial Biopsy 2% 5mL for 3 mins

10 Placebo 2% lidocaine intrauterine • Half of patients describe it as 9 “moderately” or “severely” painful 8 7 • Naproxen decreases pain 6 5 4 3  No effect on 2 pathology 1 0  = Paracervical block for EMB

Kosus M et al. Pain Res Manag, 2014; Mercier RJ et al. Obstet Gynecol, 2012, Dogan et al ObGyn 2004; Somchit et al. J Med Assoc Thai 2015 Ireland et al Obs Gyn Surv 2016 EMB Uterine Aspiration

Using a tenaculum for • Mean pain 5‐7 in most Randomized studies EMB with pipelle: an RCT N=188 UCSF Gyn clinic & • Same procedure for Women’s Options Center Without With miscarriage and abortion tenaculum tenaculum • Ibuprofen 800 mg (N=61) (N=57) • Evidence doesn’t support • Lorazepam 1‐3mg if desired oral relaxation or low dose Unable to Mean PAIN Mean PAIN • Tylenol #3 or Norco if desired IV, but patients have perform (N=3) 4.4 + 1.6 7.7 + 1.5 • Block (details later) preferences • Inadequate Inadequate Non‐pharmacological specimen specimen (N=3) (N=9)

Kucukgoz Gulec U et al. Arch Gynecol Obstet, 2014

RCT Oral Meds vs. Moderate Sedation Considerations

All: PO IV • 10% enrollment (1302 eligible  130 enrolled) 10 mg 100 mcg Ibuprofen “Caucasian, interested in the research question” Cervical block oxycodone vs. fentanyl + + • Blinded, but 85% guessed correctly 20 mL 1% lido 1 mg SL 2 mg lorazepam midazolam • All women in each arm got same meds

Intraoperative pain: 61 /100 vs. 36 /100 • Narcotic heavy oral meds Severe pain (70+): 46% vs. 15%

Allen ObGyn 2009 Allen ObGyn 2009 What U.S. Abortion Providers Use Benzodiazepines for Aspiration • Anxiety increases volume of pain signals and Local cervical decreases ability to cope 21% +/‐ oral meds • 1mg lorazepam: Anxiety scores drop instead of rise. Pain higher than those choosing nothing Local cervical + 46% • 10mg midazolam PO 30‐60 min prior: moderate – less anxiety pre‐op sedation – less nausea 33% Deep sedation – more sleepy and amnesia after or general – No change in satisfaction

Wiebe Contracep 2003; Allen Contracep 2006; O’Connell 2008 Lowenstein Contracep 2006; Bayer ObG 2017

Finally…The RCT to Show Cervical Vasopressin in Block Helps Cervical Block For Uterine Aspiration • 20 mL 1% buffered lidocaine • Increases safe amount of local anesthetic • Slow, deep injection at tenaculum + 4 sites • Prolongs effect of block • Stratified by <8 weeks (early), 8‐10 weeks (late) • Decreases blood loss (2nd trimester)1 Pain /100 BLOCK SHAM • early/late early/late May decrease re‐aspiration 2 p=.001 • Shown to decrease force for dilation with HSC With block 55 49/58 30 24/35 p<.001 Dilation 42 34/51 79 75/83 p<.001 Aspiration 63 58/67 89 88/89 • And that it works for dilator placement: 54  13/1002

1. Schulz et al. Lancet 1885; 2. Phillips ObGyn 1997 Renner. Ob Gyn May 2012; 2. Soon. ObG 2017 QUICK PAIN TIPS FOR Cervical block for uterine aspiration at UCSF WOC SIMPLE GYN PROCEDURES

1) Start with 25G needle Equipment: WHICH PROCEDURES DO YOU DO? 2) 3‐4 mL for tenaculum • 25G 1.5in or spinal needle 3) ~25 mL 4‐point paracervical • 22G spinal needle • IUD removal 4) Wait a bit to check for • Control syringe • Cervical polyp removal nausea/dizziness • Vulvar biopsy 5) ~17 mL with 22G spinal needle Recipe = 42mL: • through os at internal os and above • 20 mL 1% lidocaine Colpo and cervical biopsy 6) Check for pain with small dilators • 20 mL saline • All of the above 7) If any pain, wait longer and add • 2 mL bicarb 8.4% more plain local • 3‐4u vasopressin

IUD Removal with Strings IUD Removal WITHOUT Strings • No training necessary! 1. Confirm IUD in uterus with sono • Most important: offer other form (Remember KUB required to of contraception or preconception confirm IUD is gone) discussion Equipment: 2. Try cytobrush in cervix Ring forceps 1) Discuss possible pain 3. Consent if using forceps 2) Ask pt. to cough 4. Can try below internal os 3) Pull quickly on strings as she without tenaculum or block coughs (helps with the visceral feeling 5. Recommend tenaculum and pt often has when you remove it) block if above internal os 4) Consider block on occasion 6. Consider ultrasound Too thin Cervical Polyp Removal Vulvar Biopsy (or HPV or skin tag removal)

• Can remove cervical polyps <2cm on • Topical! a thinner stalk (mobile) eg. 2.5% lidocaine + 2% prilocaine • Equipment: • Then usually inject local w 25‐27G 1. Ring forceps needle, 0.5‐1mL 2. Silver nitrate sticks

Typically well tolerated without analgesia. Occasionally, twisting is painful and procedure should be done with paracervical block

Colpo and Cervical Biopsy Colpo and Cervical Biopsy Visual distraction reduces pain • Mean pain scores 3.0 and 3.51 • Training necessary (except for gross lesion) 321 women Most effective: undergoing colpo • Superficial 0.5 mL 1% lidocaine with 27G needle2 6 mos before and after – Significant pain reduction 4 1.2/10 renovation – Pain for injection 1.5/10 54% reduction in pain • Forced cough also helpful5 Likely NOT effective: Music also shown to • NSAIDs • Topical anesthetic 3,4,5 be helpful

1. Church ObGyn 2001, 2. Oyama Am J ObG 2003; 3. Shaughnessy J Fam Pract Carwile, JLGTD 2014 1998; 4. Wong BJOG 2008; 5. Ireland Ob Gyn Sur 2016 In Summary…

 Cultivate empathy  Demonstrate you care about patient comfort  Talk to patients about reasonable pain control options (even if you recommend against them or can’t offer them)  Individualize pre‐medication (and other care!)  Optimize local anesthesia  Pain scales aren‘t perfect, but are a good tool.