Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

Summary

This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

Timeline

Start

2020-02-10

Primary completion

2022-12-31

Completion

2022-12-31

Outcome

Missed primary endpoint

paper The primary outcome, headache improvement to visual rating scale score of 3 or lower, was not significantly different between groups (64.5% vs 51.6%, P =.30). PMID 37769308 ↗

registry analysis (superiority test); Occipital Nerve Block vs Oral Acetaminophen/Caffeine Group; p = 0.30; Chi-squared NCT03951649 ↗

Publications

• Background Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57. doi: 10.1016/0895-4356(91)90147-2.
• Background Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9. doi: 10.1212/01.wnl.0000252808.97649.21.
• Background Scharff L, Marcus DA, Turk DC. Headache during pregnancy and in the postpartum: a prospective study. Headache. 1997 Apr;37(4):203-10. doi: 10.1046/j.1526-4610.1997.3704203.x.
• Background Bushman ET, Varner MW, Digre KB. Headaches Through a Woman's Life. Obstet Gynecol Surv. 2018 Mar;73(3):161-173. doi: 10.1097/OGX.0000000000000540.
• Background Robbins MS, Farmakidis C, Dayal AK, Lipton RB. Acute headache diagnosis in pregnant women: a hospital-based study. Neurology. 2015 Sep 22;85(12):1024-30. doi: 10.1212/WNL.0000000000001954. Epub 2015 Aug 19.
• Background Loder E, Biondi D. General principles of migraine management: the changing role of prevention. Headache. 2005 Apr;45 Suppl 1:S33-47. doi: 10.1111/j.1526-4610.2005.4501002.x.
• Background Cuadrado ML, Aledo-Serrano A, Navarro P, Lopez-Ruiz P, Fernandez-de-Las-Penas C, Gonzalez-Suarez I, Orviz A, Fernandez-Perez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.
• Background Dach F, Eckeli AL, Ferreira Kdos S, Speciali JG. Nerve block for the treatment of headaches and cranial neuralgias - a practical approach. Headache. 2015 Feb;55 Suppl 1:59-71. doi: 10.1111/head.12516. Epub 2015 Feb 3.
• Background Gul HL, Ozon AO, Karadas O, Koc G, Inan LE. The efficacy of greater occipital nerve blockade in chronic migraine: A placebo-controlled study. Acta Neurol Scand. 2017 Aug;136(2):138-144. doi: 10.1111/ane.12716. Epub 2016 Dec 2.
• Background Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
• Background Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14.
• Background Tobin J, Flitman S. Occipital nerve blocks: when and what to inject? Headache. 2009 Nov-Dec;49(10):1521-33. doi: 10.1111/j.1526-4610.2009.01493.x. Epub 2009 Aug 6.
• Background Blumenfeld A, Ashkenazi A, Napchan U, Bender SD, Klein BC, Berliner R, Ailani J, Schim J, Friedman DI, Charleston L 4th, Young WB, Robertson CE, Dodick DW, Silberstein SD, Robbins MS. Expert consensus recommendations for the performance of peripheral nerve blocks for headaches--a narrative review. Headache. 2013 Mar;53(3):437-46. doi: 10.1111/head.12053. Epub 2013 Feb 13.
• Background Voigt CL, Murphy MO. Occipital nerve blocks in the treatment of headaches: safety and efficacy. J Emerg Med. 2015 Jan;48(1):115-29. doi: 10.1016/j.jemermed.2014.09.007. Epub 2014 Oct 18.
• Background Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.
• Background Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92. doi: 10.1001/archinte.160.22.3486.
• Background Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499.
• Background James AH, Brancazio LR, Price T. Aspirin and reproductive outcomes. Obstet Gynecol Surv. 2008 Jan;63(1):49-57. doi: 10.1097/OGX.0b013e31815e8731.
• Background Korucu O, Dagar S, Corbacioglu SK, Emektar E, Cevik Y. The effectiveness of greater occipital nerve blockade in treating acute migraine-related headaches in emergency departments. Acta Neurol Scand. 2018 Sep;138(3):212-218. doi: 10.1111/ane.12952. Epub 2018 May 10.
• Background Allen SM, Mookadam F, Cha SS, Freeman JA, Starling AJ, Mookadam M. Greater Occipital Nerve Block for Acute Treatment of Migraine Headache: A Large Retrospective Cohort Study. J Am Board Fam Med. 2018 Mar-Apr;31(2):211-218. doi: 10.3122/jabfm.2018.02.170188.
• Background Negro A, Delaruelle Z, Ivanova TA, Khan S, Ornello R, Raffaelli B, Terrin A, Reuter U, Mitsikostas DD; European Headache Federation School of Advanced Studies (EHF-SAS). Headache and pregnancy: a systematic review. J Headache Pain. 2017 Oct 19;18(1):106. doi: 10.1186/s10194-017-0816-0.
• Background Schoen JC, Campbell RL, Sadosty AT. Headache in pregnancy: an approach to emergency department evaluation and management. West J Emerg Med. 2015 Mar;16(2):291-301. doi: 10.5811/westjem.2015.1.23688. Epub 2015 Feb 25.
• Background Lipton RB, Diener HC, Robbins MS, Garas SY, Patel K. Caffeine in the management of patients with headache. J Headache Pain. 2017 Oct 24;18(1):107. doi: 10.1186/s10194-017-0806-2.
• Background Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.
• Bushman ET, Blanchard CT, Cozzi GD, Davis AM, Harper L, Robbins LS, Jones B, Szychowski JM, Digre KB, Casey BM, Tita AT, Sinkey RG. Occipital Nerve Block Compared With Acetaminophen and Caffeine for Headache Treatment in Pregnancy: A Randomized Controlled Trial. Obstet Gynecol. 2023 Nov 1;142(5):1179-1188. doi: 10.1097/AOG.0000000000005386. Epub 2023 Sep 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Acetaminophen	Small molecule	650 mg	Oral
Subject	Bupivacaine	Other / unclassified	0.5 %	Other
Subject	Bupivacaine	Other / unclassified	5 ml	Other
Subject	Caffeine	Small molecule	100 mg	Oral

Indications