The impact of biological sex in peripheral nerve blockade : A prospective pharmacodynamic, pharmacokinetic and morphometric study in volunteers
Copyright: © 2024 Zadrazil et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited..
STUDY OBJECTIVE: The impact of biological sex in peripheral regional anaesthesia is largely unknown. We therefore designed a prospective study in volunteers to investigate the impact of biological sex on pharmacodynamic, pharmacokinetic and morphometric characteristics for peripheral nerve blockade.
METHODS: The initial study plan was powered to include 90 volunteers to find a difference of 35 min in duration of sensory block (primary outcome variable) with 80% power and alpha error at 5%. After discussions in ethical review, a pilot study of 2 x 12 volunteers from each sex were studied. Female and male volunteers received ultrasound guided nerve blockade with 3.0 mL ropivacaine 7.5 mg mL-1. Sensory duration of blockade, as the primary outcome, was evaluated by pinprick testing. Secondary outcomes were sensory onset time of blockade, pharmacokinetic characteristics and the visibility of ulnar nerves using ultrasound. Analyses included Mann-Whitney U-statistics with P<0.05 (two-sided) as significant.
RESULTS: After 24 participants, the median (IQR) duration of sensory blockade was 450 (420; 503) min in women and 480 (450; 510) min in men (P = 0.49). Sensory onset time of blockade, and ultrasound visibility of nerves were also similar between the study groups. The total drug exposure across time (AUC0-infinity) was significantly higher in women (P = 0.017). After a the planned power re-analysis after these 24 study paticipants, which suggested that > 400 subjects would be required with 80% power and alpha error of 5% to find significance for the primary outcome parameter for marginal differences, we terminated the study at this point.
CONCLUSIONS: We did not detect significant differences between female and male study participants in terms of pharmacodynamic and morphometric characteristics after ultrasound guided ulnar nerve blocks. Women did show significantly greater pharmacokinetic ropivacaine exposures. The results of this study indicate that peripheral regional block pharmacodynamic characteristics are independent of the biological sex, whereas pharmacokinetic parameters are sex-dependent.
| Medienart: |
E-Artikel |
|---|
| Erscheinungsjahr: |
2024 |
|---|---|
| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:19 |
|---|---|
| Enthalten in: |
PloS one - 19(2024), 1 vom: 26., Seite e0297095 |
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Zadrazil, Markus [VerfasserIn] |
|---|
| Links: |
|---|
| Themen: |
7IO5LYA57N |
|---|
| Anmerkungen: |
Date Completed 29.01.2024 Date Revised 29.01.2024 published: Electronic-eCollection Citation Status MEDLINE |
|---|
| doi: |
10.1371/journal.pone.0297095 |
|---|
| funding: |
|
|---|---|
| Förderinstitution / Projekttitel: |
|
| PPN (Katalog-ID): |
NLM367677687 |
|---|
| LEADER | 01000caa a22002652 4500 | ||
|---|---|---|---|
| 001 | NLM367677687 | ||
| 003 | DE-627 | ||
| 005 | 20240129232217.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 240127s2024 xx |||||o 00| ||eng c | ||
| 024 | 7 | |a 10.1371/journal.pone.0297095 |2 doi | |
| 028 | 5 | 2 | |a pubmed24n1274.xml |
| 035 | |a (DE-627)NLM367677687 | ||
| 035 | |a (NLM)38277353 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 100 | 1 | |a Zadrazil, Markus |e verfasserin |4 aut | |
| 245 | 1 | 4 | |a The impact of biological sex in peripheral nerve blockade |b A prospective pharmacodynamic, pharmacokinetic and morphometric study in volunteers |
| 264 | 1 | |c 2024 | |
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ƒaComputermedien |b c |2 rdamedia | ||
| 338 | |a ƒa Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Date Completed 29.01.2024 | ||
| 500 | |a Date Revised 29.01.2024 | ||
| 500 | |a published: Electronic-eCollection | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright: © 2024 Zadrazil et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. | ||
| 520 | |a STUDY OBJECTIVE: The impact of biological sex in peripheral regional anaesthesia is largely unknown. We therefore designed a prospective study in volunteers to investigate the impact of biological sex on pharmacodynamic, pharmacokinetic and morphometric characteristics for peripheral nerve blockade | ||
| 520 | |a METHODS: The initial study plan was powered to include 90 volunteers to find a difference of 35 min in duration of sensory block (primary outcome variable) with 80% power and alpha error at 5%. After discussions in ethical review, a pilot study of 2 x 12 volunteers from each sex were studied. Female and male volunteers received ultrasound guided nerve blockade with 3.0 mL ropivacaine 7.5 mg mL-1. Sensory duration of blockade, as the primary outcome, was evaluated by pinprick testing. Secondary outcomes were sensory onset time of blockade, pharmacokinetic characteristics and the visibility of ulnar nerves using ultrasound. Analyses included Mann-Whitney U-statistics with P<0.05 (two-sided) as significant | ||
| 520 | |a RESULTS: After 24 participants, the median (IQR) duration of sensory blockade was 450 (420; 503) min in women and 480 (450; 510) min in men (P = 0.49). Sensory onset time of blockade, and ultrasound visibility of nerves were also similar between the study groups. The total drug exposure across time (AUC0-infinity) was significantly higher in women (P = 0.017). After a the planned power re-analysis after these 24 study paticipants, which suggested that > 400 subjects would be required with 80% power and alpha error of 5% to find significance for the primary outcome parameter for marginal differences, we terminated the study at this point | ||
| 520 | |a CONCLUSIONS: We did not detect significant differences between female and male study participants in terms of pharmacodynamic and morphometric characteristics after ultrasound guided ulnar nerve blocks. Women did show significantly greater pharmacokinetic ropivacaine exposures. The results of this study indicate that peripheral regional block pharmacodynamic characteristics are independent of the biological sex, whereas pharmacokinetic parameters are sex-dependent | ||
| 650 | 4 | |a Journal Article | |
| 650 | 7 | |a Ropivacaine |2 NLM | |
| 650 | 7 | |a 7IO5LYA57N |2 NLM | |
| 650 | 7 | |a Anesthetics, Local |2 NLM | |
| 650 | 7 | |a Amides |2 NLM | |
| 700 | 1 | |a Marhofer, Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Columb, Malachy |e verfasserin |4 aut | |
| 700 | 1 | |a Opfermann, Philipp |e verfasserin |4 aut | |
| 700 | 1 | |a Schmid, Werner |e verfasserin |4 aut | |
| 700 | 1 | |a Marhofer, Daniela |e verfasserin |4 aut | |
| 700 | 1 | |a Stimpfl, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Reichel, Sabine |e verfasserin |4 aut | |
| 700 | 1 | |a Al Jalali, Valentin |e verfasserin |4 aut | |
| 700 | 1 | |a Zeitlinger, Markus |e verfasserin |4 aut | |
| 773 | 0 | 8 | |i Enthalten in |t PloS one |d 2006 |g 19(2024), 1 vom: 26., Seite e0297095 |w (DE-627)NLM167327399 |x 1932-6203 |7 nnns |
| 773 | 1 | 8 | |g volume:19 |g year:2024 |g number:1 |g day:26 |g pages:e0297095 |
| 856 | 4 | 0 | |u http://dx.doi.org/10.1371/journal.pone.0297095 |3 Volltext |
| 912 | |a GBV_USEFLAG_A | ||
| 912 | |a GBV_NLM | ||
| 951 | |a AR | ||
| 952 | |d 19 |j 2024 |e 1 |b 26 |h e0297095 | ||