- Guest Post by Dr. Bob Twillman
Earlier this week, I got myself into some very hot water by tweeting a link to a story from MedPageToday. The article reported on a study presented at a meeting of the Society of Maternal-Fetal Medicine, investigating whether, in women who had had Cesarean deliveries (CDs), adding opioids to a post-partum regimen of ibuprofen plus acetaminophen provided additional pain relief. The headline on that article provoked me, and while, in no way did I intend my tweet to be an endorsement of the study’s findings, within the span of about three tweets, I felt like I was being perceived as a misogynist who thought women needed nothing for CD pain and should be expected to go right back to work in the fields the next day. Nothing could be further from the truth, and closer examination of the study in question makes me think it never should have seen the light of day.
The researchers conducted an open label trial in which women who had CDs were discharged from the hospital with a randomly selected pain regimen. One group received ibuprofen 600 mg every six hours plus acetaminophen 325 mg, one to two every four hours. The other group received the same dose of ibuprofen, but instead of single-agent acetaminophen, they were prescribed hydrocodone/acetaminophen 5/325, also one to two every four hours. Note that the only difference between the two regimens was 5 to 10 mg of hydrocodone every four hours. Two to four weeks later (mean = 15 and 17 days), the patients were asked to rate their pain on a visual analogue scale (VAS).
In analyzing the results, the authors note that the mean difference in VAS pain ratings was 4.89 mm on (presumably, since the authors didn’t specify) a 100 mm scale; that difference has a 95% confidence interval from -2.19 to 11.9—signifying no statistical difference between the groups. But wait—the authors determined that the treatments should be considered equivalent only if the confidence interval was between -10 and +10 mm. How they made this determination, and whether they did so before or after running the test, was not stated. So, even though the statistical test was non-significant, the authors concluded that there was, in fact, a significant difference, with the opioid group faring worse.
Closer examination of the data, however, reveals something more telling: the mean VAS score for the non-opioid group (two to four weeks post-partum) was 12.3, while the mean score for the opioid group was 15.9. In other words, using the common 0-10 scale used to rate pain, the average pain scores were 1.23 and 1.59. I have more pain than that when I get up in the morning! To say that one of these groups has significantly more pain than the other reminds me of one of my favorite aphorisms: “Twice nothing is still nothing!”
One wonders how much pain the authors would have found at 2-4 weeks post-partum if they had given the women placebos.
By waiting until two to four weeks post-partum to measure pain, the authors completely ignored the time frame when pain medications might be most helpful, i.e., while the surgical incision was healing. The important question is not how much pain a woman has after her CD incision has healed, but how much pain she has while it is healing—something the authors completely ignored.
The primary danger in publishing scientific nonsense like this is that someone will see the headline, read the abstract, and conclude that all women having CD can do without opioids. This study does not lend itself to that conclusion. In answer to the MedPageToday headline (Pain After C-Section: Are Opioids Really Necessary?), all we can really say is that this study doesn’t tell us the answer.
It is true that there are physiological reasons to expect that ibuprofen and acetaminophen could be helpful in reducing post-CD pain, but we need a much-better designed study to determine if opioids add significantly to those effects. Maybe opioids really aren’t necessary. I don’t know, because I’ve never had a CD, but that looks like a significant surgery to me, and if it was my significant other having the procedure, I’d recommend the opioids.
There is one more thing that will probably keep me in hot water, but it probably needs to be said: given the prevailing practice in this country of prescribing opioids after a CD, it is statistically unlikely that any of the women who tweeted back at me, attesting to the necessity of opioids, had actually used only ibuprofen and acetaminophen after their procedures. They only know their own experience and can attest to the fact that their opioid regimens reduced their pain, but they can’t tell us how much more or less pain they would have had with only ibuprofen and acetaminophen. Don’t misunderstand me—I am not advocating for avoiding opioids in this setting, but there is still an open question as to how much they really are needed—especially if state-of-the-art treatments like liposomal bupivacaine was used.
In the widespread zeal to reduce opioid prescribing, it is inevitable that unwitting researchers and reporters will conduct, and then report on, studies that purport to show that opioids produce no more pain relief than non-opioid pain medications. There may be elements of truth in those reports, but we need to keep everyone honest by examining the study’s methods closely and identifying possible sources of bias when we find them.
Dr. Fudin: To add icing on Dr. Twillman’s post, I recently experienced a situation where a young woman with preeclampsia (well-known to me) underwent an emergency CD. Post CD, she was denied opioids because “we try to avoid them in young woman due to potential for abuse and addiction”. In the meantime, her blood pressure was 178/105. I couldn’t believe that the doctor told me “naproxen doesn’t raise the blood pressure too much”. She knew I was a pharmacist which was even more infuriating. I asked her if she evaluated this patient for opioid addiction risk – she looked at me like I had three heads. Turns out there was no risk, and if anything, a negative risk! I made it crystal clear to the OB-GYN attending that she was dead wrong, that NSAIDs where clearly contraindicated in this situation, in favor of opioids, and if the end result was seizure, stroke, blindness, or death, she would be sure to see me in court! THANK YOU DR. TWILLMAN FOR CRITIQUING THIS MISGUIDED STUDY.
As always, comments are encouraged and welcome!!!
A clinical psychologist, Dr. Twillman is the former executive director of the Academy of Integrative Pain Management. He advocates widely for rational pain management policy that promotes the availability of comprehensive integrative pain care.
Thank you for this article! As a women who had an unexpected C-section and also feeling like “hey I am a pain pharmacist I don’t need opioids” I also tried to go without the percocet POD#1 and ended up crying in the shower pressing the call button and NEEDING HELP. Not only could I not get up on my own, but I could not feed my son. I do not advocate for 2-4 weeks of opioids post op, but being able to heal while also being able to walk up the stairs in my own home was a necessity. Using APAP and NSAIDs (again because I don’t have any other risk factors) was also great but opioids were need the first week because it was major surgery! I once had a doctor, a women, who I respect as a provider state, “giving an opioid to someone after a CD is like giving a bazooka to a mosquito bite.” I needed opioids to heal, recover, and bond with my baby and it truly is a shame when providers do not see it that way and are more concerned about prescribing opioids than allowing a women that just went through a mini war to heal.
Thank you for this great response Dr. Cleary!
I’ve had two c-sections.
I decided to forego percocet when I was scheduled to receive it the second time post-op. I’d been taking the maximum dose of ibuprofen around the clock.
Thirteen hours had passed after declining my second dose of percocet when I woke up in horrific pain. I was doubled-over in pain. The nurse gave me the percocet but insisted that I needed to get up to walk in order to prevent a blood clot. I was still doubled-over in pain while walking in the hall of the hospital.
I will never forget that pain.
I have a high pain threshold, and during my second c-section we quickly learned that the spinal block didn’t work; I felt all three slices, but that pain didn’t even come close to the post-op pain after my first c-section.
Additionally, I am a rapid metabolizer, and when I had finished my prescription for percocet many days after my first c-section, I had to have my doctor call in a prescription for Vicodin.
Withholding opioids after a c-section is cruel and inhumane.
Why the hell aren’t doctors having conversations with patients about the patient’s after surgery pain management needs and preferences as a requirement prior to ANY surgery? Some patients don’t want opioids (or nsaids or other pain treatments) for various reasons, others with chronic pain may need MORE than the usual doses, and some don’t know and need flexibility, Inflexibility, prejudice and “one size fits all” has no place in medical care.
When are the powers that be going to recognize that we are all different and one size does not fit all. That is why for the safety and welfare of the patient the doctor needs to be able to tailor pain management as well as treatment for any conditions while in his or her care based on what his or her patient actually needs at the time. And all of that is subject to the patients health history and problems. And everyone’s pain tolerance is different. One patient might get by with OTCs while another needs the opiate. Also this is not cookie cutter surgery. Baby position, location of nerves, size of incision, surgeon’s skill, size of baby, amount of pulling to get the baby out, amount of bleeding and swelling an individual might have all have an effect on the amount of pain someone might have and the amount and type of medication they might need. Not to mention a person’s genetic make-up determines how they might metabolize a medication. Each person needs to be treated based on their individual situation period.
Well, Jeff, its Opioid Porn again I guess! A slightly different “take” on this subject, because we are on the opposite side of this pendulum: as a clinical pharmacist in a hospital that performs C sections, we initiated a pharmacy pain stewardship initiative: scheduled acetaminophen 1000mg po every 6 hours, ibuprofen 600mg every 6 hours, lidocaine patch for incisional pain kept on 24 hours, and oxycodone 5 or 10mg every 4 hours as needed for moderate or severe pain, respectively. We did this because prior, all of these medications were prescribed “if needed” and no chance to pre-empt pain. (Why is it so difficult for providers to prescribe around the clock non-opioids?) Our findings: patients used 20% less opioid, there was a 41% decrease in opioid administration for severe pain, and a 43% increase in patients receiving an opioid for moderate pain, meaning less amount of opioid administered. Not all patients used opioids. We did not remove the outliers, we did have a couple of patients with OUD on Suboxone but we probably did in the historical group as well. The obstetricians were pleased and perhaps surprised. There was no correlation between amount used in hospital compared to discharge quantity. Some who received none were prescribed 30 tablets on discharge, some who received 30 tablets as inpatients received 12 tablets on discharge. This was not research, no stats applied…but my point is can’t we do research that makes sense! Thanks for revealing this study Dr. Twillman.
Lynn, Thanks for the comments. Here’s the ironic thing… You did the study right and didn’t attempt to publish it; they did the study wrong and did attempt to publish it.
God help us all. And I do mean ALL. Not one of us is but a few steps in life from being the victim of the growing inhumanity against people in pain. If you have a neurological system, you are a candidate for inhumane levels of pain by those who either think your pain doesn’t matter because they aren’t in pain. Or they who have something to gain by your pain. I’ve toughed out a lot of pain in life. Believe people who say they are in pain. We aren’t stooping the war on drugs by denying pain medicine, we aren’t even creating a drug war if we give an addict pain medicine occasionally, erring on the side of never letting someone suffer inhumane pain in the name of stooping that one addict. Which is worse? I climbed to the top of Timp and thought I was invincible. I worked 2 jobs through college. Occasionally 3. I. Was. Tough! 3 C sections I bounced right back from. I. Was. Tough. I know intolerable from tolerable pain. I hope you doubters never know the difference. But I hope you can imagine it. And FIGHT those with agendas that always lead to their power and money increasing at the expense of exploiting the vulnerable. Whenever you hear the vulnerable screaming into the void, please suspect that the void is created by the power-hungry who are exploiting them.
I was SO TOUGH that I suffered through psoriatic arthritis, enthesopathy of the pelvis to the point of looking like Swiss Cheese, 4 herniated discs, assorted osteophytes and stenosis, an annular tear, and stage 1,2, and 3 COPD with emphysema thinking that everyone must feel like this after a hard days work. By the time I was forced to seek assistance, I first was subjected to all the not very effective gabapentin/Cymbalta/ injections/ N-said/RFA/ etc before opioid therapy which was never titrated to sufficient pain control was finally implemented. After those wasted years I discovered that my COPD was at end stage with an FEV1 less than 20% of normal and I’m terminally ill. I simply felt so bad for so long that I forgot how normal people feel.
Excellent and astute analysis! Also, minor (‘twice of nothing’ as Bob said) differences can also be due to other methodological reasons than being randomized to opioids…the two groups look different at baseline on some known risk factors for pain outcomes.. e.g. more SES disadvantage (Medicaid) in the opioid group. Unfortunately, media and most consumers of the so-called evidence will go by the authors’ conclusions alone.
Thank you Salimah. “…consumers of the so-called evidence will go by the authors’ conclusions alone” – ain’t that the truth!!!
Note also that the opioid group (with a supposedly lower pain level were surveyed, on average, two days later in their course. Normally, that might not be significant, but for such a small difference, on a recovery trajectory, it could have had an effect.
I just don’t take heed in these types of studes. The reason being is I’ve had many friends over the years who have had C-sections. Some have experienced horrible pain while others have had very little. Pain tolerance is just to individualized to do any type of group study. I don’t understand why that fact has not been realized yet,
Terri, That is a VERY valid point!!!
I had two c-sections and I can point blank attest that I would not have been able to recover well without them. But one has to remember if you are breastfeeding that one needs to be careful how much one takes as it could affect the baby, making them more sleepy, however, c-sections are very painful recoveries, and it is vital that the pain is treated bc we also are dealing with lack of sleep and major surgery AND we have to take care of a newborn. Most people who have major surgery do not have to then take care of a baby, in fact they are advised to get plenty of rest and to not lift anything over 5-10 pounds.
There are so many health systems trying to not prescribe opioids after surgery. Failing to offer opioids after surgery without patient informed consent is a human rights issue. On twitter @mattbc noted: “15 second hypothetical: You operate on a prisoner of war and deliberately withhold available opioids. Congratulations, you’re a war criminal.”
Anne, So true – I love the analogy!
Great work, Bob and Jeff!!!
Thank you Michael, but all the credit here goes to Bob for exposing this this for what it is. I just provided the medium.